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Résztvevőt keres itt: Egyesült Államok3. fázis

Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula

A legfontosabb adatok

Hol
Aitkin, Albuquerque, Allentown, Ann Arbor, Ashland, Atlanta, Battle Creek, Baxter, Bethlehem, Birmingham, Brainerd, Burlington, Chadds Ford, Charlotte, Chicago, Cincinnati, Columbus, Concord, Crosslake, Daphne, Deer River, Detroit Lakes, Duarte, Duluth, Easton, Elkton, Ely, Fairhope, Fargo, Farmington, Fosston, Geneva, Gilbert, Grand Rapids, Hayward, Hibbing, Indianapolis, International Falls, Jamestown, Johns Creek, Knoxville, La Jolla, Lexington, Livingston, Loma Linda, Los Angeles, Marshfield, Memphis, Mobile, Moose Lake, Mukwonago, Muskegon, New Brunswick, New Orleans, Newark, Niles, Norton Shores, Oak Brook, Oconomowoc, Omaha, Orland Park, Park Rapids, Pequot Lakes, Pine River, Quakertown, Reed City, Reno, Richmond, Roanoke, Rochester, Ruskin, Saint Joseph, Sainte Genevieve, San Diego, Sandstone, Saraland, Seattle, Sioux Falls, Spooner, St Louis, Staples, Stroudsburg, Sullivan, Sunset Hills, Superior, Syracuse, Tampa, Virginia, Warrenville, Waukesha, Wesley Chapel, West Chester, Wilkes-Barre, Wilmington, Winchester és Wyoming (Egyesült Államok)Mind a 118 helyszín megnézése
Fázis
3. fázis

AI-kivonat: kiket keres a vizsgálat

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat olyan felnőtteket keres, akiknek hasnyálmirigyrákjuk vagy rákká válhatható hasnyálmirigy-elváltozásuk van, és hasnyálmirigy-farokeltávolító műtétjük van betervezve. A műtét előtt adott lanreotid hatását vizsgálják a hasnyálmirigy-sipoly megelőzésére.

Életkor
18 éves vagy idősebb
Nem
Minden nem csatlakozhat
A betegség stádiuma
Hasnyálmirigyrák vagy rákká válhatható hasnyálmirigy-elváltozás, szövettani vagy képalkotó vizsgálattal igazolva. Tervezett (elektív) distalis pancreatectomia a regisztrációt követő 60 napon belül.
Korábbi kezelés
A csatlakozás előtti 180 napban nem kaphatott szomatosztatin-analógot. Nem kapott sugárkezelést a hasnyálmirigy daganata miatt. Nem kapott peptid receptor radionuklid terápiát (PRRT).

A részvétel fő kizáró okai

  • Ismert felszívódási zavar (malabszorpciós szindróma) a kórtörténetben
  • Olyan műtét, amelyhez módosított Appleby-típusú eljárás, több szerv eltávolítása vagy daganatkimagzás (enukleáció) kell
  • Közepes vagy súlyos májkárosodás (AST 190 U/L felett vagy ALT 320 U/L felett)
  • Terhesség vagy szoptatás
  • Túl gyenge vesefunkció (kreatinin-clearance 50 mL/perc alatt)

Gépi kiolvasás: 2026. november 12.

Helyszínek itt: Egyesült Államok

  • Riverwood Healthcare CenterAitkin, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • University of New Mexico Cancer CenterAlbuquerque, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Saint Luke's Cancer Center - AllentownAllentown, Egyesült ÁllamokContact: Darius C. Desai (principal investigator)Résztvevőt keres
  • University of Michigan Rogel Cancer CenterAnn Arbor, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Duluth Clinic AshlandAshland, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Northwest Wisconsin Cancer CenterAshland, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Emory Saint Joseph's HospitalAtlanta, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Emory University Hospital MidtownAtlanta, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Emory University Hospital/Winship Cancer InstituteAtlanta, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Grady Health SystemAtlanta, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Bronson Battle CreekBattle Creek, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Essentia Health - Baxter ClinicBaxter, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Saint Luke's University Hospital-Bethlehem CampusBethlehem, Egyesült ÁllamokContact: Darius C. Desai (principal investigator)Résztvevőt keres
  • University of Alabama at Birmingham Cancer CenterBirmingham, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Essentia Health Saint Joseph's Medical CenterBrainerd, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • University of Vermont and State Agricultural CollegeBurlington, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • University of Vermont Medical CenterBurlington, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Christiana Care Health System-Concord Health CenterChadds Ford, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Carolinas Medical Center/Levine Cancer InstituteCharlotte, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Northwestern UniversityChicago, Egyesült ÁllamokContact: Akhil Chawla (principal investigator)Résztvevőt keres
  • University of IllinoisChicago, Egyesült ÁllamokContact: Aslam Ejaz (principal investigator)Résztvevőt keres
  • University of Cincinnati Cancer Center-UC Medical CenterCincinnati, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Ohio State University Comprehensive Cancer CenterColumbus, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Atrium Health Cabarrus/LCI-ConcordConcord, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Essentia Health - Saint Joseph's Crosslake ClinicCrosslake, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Gulf Health Hospitals Inc/Infirmary Cancer Care - MalbisDaphne, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Essentia Health - Deer River ClinicDeer River, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Essentia Health Saint Mary's - Detroit Lakes ClinicDetroit Lakes, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • City of Hope Comprehensive Cancer CenterDuarte, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Essentia Health Cancer CenterDuluth, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Essentia Health Saint Mary's Medical CenterDuluth, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Miller-Dwan HospitalDuluth, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Saint Luke's Hospital-Anderson CampusEaston, Egyesült ÁllamokContact: Darius C. Desai (principal investigator)Résztvevőt keres
  • Christiana Care - Union HospitalElkton, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Essentia Health - Ely ClinicEly, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Thomas HospitalFairhope, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Essentia Health Cancer Center-South University ClinicFargo, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Sanford Broadway Medical CenterFargo, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Sanford Roger Maris Cancer CenterFargo, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Parkland Health Center - FarmingtonFarmington, Egyesült ÁllamokContact: Bryan A. Faller (principal investigator)Résztvevőt keres
  • Essentia Health - FosstonFosston, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Northwestern Medicine Cancer Center DelnorGeneva, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Banner MD Anderson Cancer CenterGilbert, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Corewell Health Grand Rapids Hospitals - Butterworth HospitalGrand Rapids, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's HospitalGrand Rapids, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Trinity Health Grand Rapids HospitalGrand Rapids, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Essentia Health-Hayward ClinicHayward, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Tamarack Health Hayward Medical CenterHayward, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Essentia Health Hibbing ClinicHibbing, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Indiana University/Melvin and Bren Simon Cancer CenterIndianapolis, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Essentia Health - International Falls ClinicInternational Falls, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Essentia Health - Jamestown ClinicJamestown, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Emory Johns Creek HospitalJohns Creek, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • University of Tennessee - KnoxvilleKnoxville, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • UC San Diego Moores Cancer CenterLa Jolla, Egyesült ÁllamokContact: Andrew M. Lowy (principal investigator)Résztvevőt keres
  • University of Kentucky/Markey Cancer CenterLexington, Egyesült ÁllamokContact: Michael J. Cavnar (principal investigator)Résztvevőt keres
  • Saint Barnabas Medical CenterLivingston, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Veterans Affairs Loma Linda Healthcare SystemLoma Linda, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • USC / Norris Comprehensive Cancer CenterLos Angeles, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Marshfield Medical Center-MarshfieldMarshfield, Egyesült ÁllamokContact: Jessica A. Wernberg (principal investigator)Résztvevőt keres
  • Baptist Memorial Hospital and Cancer Center-MemphisMemphis, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Mobile Infirmary Medical CenterMobile, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Essentia Health - Moose Lake ClinicMoose Lake, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • ProHealth D N Greenwald CenterMukwonago, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Trinity Health Muskegon HospitalMuskegon, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Rutgers Cancer Institute of New JerseyNew Brunswick, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • University Medical Center New OrleansNew Orleans, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Christiana Care Health System-Christiana HospitalNewark, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Helen F Graham Cancer CenterNewark, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Medical Oncology Hematology Consultants PANewark, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Corewell Health Lakeland Hospitals - Niles HospitalNiles, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Cancer and Hematology Centers of Western Michigan - Norton ShoresNorton Shores, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Northwestern Medicine Oak BrookOak Brook, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • ProHealth Oconomowoc Memorial HospitalOconomowoc, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • University of Nebraska Medical CenterOmaha, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Northwestern Medicine Orland ParkOrland Park, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Essentia Health - Park RapidsPark Rapids, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Essentia Health - Saint Joseph's Pequot Lakes ClinicPequot Lakes, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Essentia Health - Saint Joseph's Pine River ClinicPine River, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Saint Luke's Hospital - Upper Bucks CampusQuakertown, Egyesült ÁllamokContact: Darius C. Desai (principal investigator)Résztvevőt keres
  • Corewell Health Reed City HospitalReed City, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Renown Regional Medical CenterReno, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • VCU Massey Cancer Center at Stony PointRichmond, Egyesült ÁllamokContact: Leopoldo J. Fernandez (principal investigator)Résztvevőt keres
  • VCU Massey Comprehensive Cancer CenterRichmond, Egyesült ÁllamokContact: Leopoldo J. Fernandez (principal investigator)Résztvevőt keres
  • Carilion Roanoke Memorial HospitalRoanoke, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • University of RochesterRochester, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Moffitt Cancer Center at SouthShoreRuskin, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Corewell Health Lakeland Hospitals - Marie Yeager Cancer CenterSaint Joseph, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Corewell Health Lakeland Hospitals - Saint Joseph HospitalSaint Joseph, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Sainte Genevieve County Memorial HospitalSainte Genevieve, Egyesült ÁllamokContact: Bryan A. Faller (principal investigator)Résztvevőt keres
  • UC San Diego Medical Center - HillcrestSan Diego, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Essentia Health SandstoneSandstone, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Gulf Health Hospitals Inc/Infirmary Cancer Care - SaralandSaraland, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Fred Hutchinson Cancer CenterSeattle, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • University of Washington Medical Center - MontlakeSeattle, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Sanford Cancer Center Oncology ClinicSioux Falls, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Sanford USD Medical Center - Sioux FallsSioux Falls, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Essentia Health-Spooner ClinicSpooner, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Missouri Baptist Medical CenterSt Louis, Egyesült ÁllamokContact: Bryan A. Faller (principal investigator)Résztvevőt keres
  • Essentia Health - Saint Joseph's Staples ClinicStaples, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Saint Luke's Hospital - Monroe CampusStroudsburg, Egyesült ÁllamokContact: Darius C. Desai (principal investigator)Résztvevőt keres
  • Missouri Baptist Sullivan HospitalSullivan, Egyesült ÁllamokContact: Bryan A. Faller (principal investigator)Résztvevőt keres
  • BJC Outpatient Center at Sunset HillsSunset Hills, Egyesült ÁllamokContact: Bryan A. Faller (principal investigator)Résztvevőt keres
  • Essentia Health Saint Mary's Hospital - SuperiorSuperior, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • State University of New York Upstate Medical UniversitySyracuse, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Moffitt Cancer Center - McKinley CampusTampa, Egyesült ÁllamokContact: Andrew J. Sinnamon (principal investigator)Résztvevőt keres
  • Moffitt Cancer CenterTampa, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Moffitt Cancer Center-International PlazaTampa, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Essentia Health Virginia ClinicVirginia, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Northwestern Medicine Cancer Center WarrenvilleWarrenville, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • ProHealth Waukesha Memorial HospitalWaukesha, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • UW Cancer Center at ProHealth CareWaukesha, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Moffitt Cancer Center at Wesley ChapelWesley Chapel, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • University of Cincinnati Cancer Center-West ChesterWest Chester, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Geisinger Wyoming Valley/Henry Cancer CenterWilkes-Barre, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Christiana Care Health System-Wilmington HospitalWilmington, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • Valley Health / Winchester Medical CenterWinchester, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part
  • University of Michigan Health - WestWyoming, Egyesült ÁllamokContact: Andrea GarciaNo longer taking part

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

A vizsgálat adatai

Ki végzi
SWOG Cancer Research Network
Azonosító
NCT06807437
A regiszteradat frissítve
2026. november 6.
Eredeti leírás
This phase III trial compares the effect of using lanreotide before surgery to surgery alone in preventing pancreatic fistulas in patients with pancreatic cancer or a pancreatic lesion that could become cancerous. Lanreotide, a type of somatostatin analog similar to somatostatin (a hormone made by the body), and is used to treat certain types of gastroenteropancreatic neuroendocrine tumors, and carcinoid syndrome. It may help stop the body from making extra amounts of certain hormones, including growth hormone, insulin, glucagon, and hormones that affect digestion. It may also help keep certain types of tumor cells from growing. Patients with pancreatic cancer or pancreatic lesions may undergo surgery to remove parts of the pancreas, also called a distal pancreatectomy. Patients may experience complications after surgery, including pancreatic fistulas. A pancreatic fistula occurs when there is a small leak from the pancreas, causing fluids to collect. This can often lead to infection and other problems. Giving lanreotide before undergoing distal pancreatectomy may be more effective than surgery alone in preventing the development of a pancreatic fistula in patients with pancreatic cancer or a pancreatic lesion that could become cancerous.A teljes eredeti leírásKevesebb

A Randomized Phase III Blinded Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula

This phase III trial compares the effect of using lanreotide before surgery to surgery alone in preventing pancreatic fistulas in patients with pancreatic cancer or a pancreatic lesion that could become cancerous. Lanreotide, a type of somatostatin analog similar to somatostatin (a hormone made by the body), and is used to treat certain types of gastroenteropancreatic neuroendocrine tumors, and carcinoid syndrome. It may help stop the body from making extra amounts of certain hormones, including growth hormone, insulin, glucagon, and hormones that affect digestion. It may also help keep certain types of tumor cells from growing. Patients with pancreatic cancer or pancreatic lesions may undergo surgery to remove parts of the pancreas, also called a distal pancreatectomy. Patients may experience complications after surgery, including pancreatic fistulas. A pancreatic fistula occurs when there is a small leak from the pancreas, causing fluids to collect. This can often lead to infection and other problems. Giving lanreotide before undergoing distal pancreatectomy may be more effective than surgery alone in preventing the development of a pancreatic fistula in patients with pancreatic cancer or a pancreatic lesion that could become cancerous.

Bevonási feltételek: Participants must have histologically or radiographically confirmed diagnosis of pancreatic cancer or a pancreatic lesion with malignant potential; Participants must have an elective distal pancreatectomy planned to occur within 60 days after registration/randomization date; Participants must not have a known history of a prior diagnosis of malabsorption syndrome; Participants must not have been treated with any somatostatin analogue within 180 days prior to registration/randomization; Participants must not have been treated with radiation therapy for their pancreas malignancy at any time prior to registration/randomization; Participants must not have been treated with peptide receptor radionuclide therapy (PRRT) at any time prior to registration/randomization; Participants must be ≥ 18 years old; Participants must have a complete documented medical history and physical exam within 28 days prior to registration/randomization; Participants must have a creatinine ≤ the institutional upper limit of normal (IULN) OR a measured OR calculated creatinine clearance ≥ 50 mL/min using the following Cockcroft -Gault formula within 60 days prior to registration/randomization; Participants must complete a pre-registration screening to identify any of the medications below, allowing the study team and treating physician to develop a monitoring plan as needed. Participants taking medications with known interactions with lanreotide may remain eligible if appropriate monitoring and management are in place. These medications include:; Diabetes medications (insulin or oral hypoglycemics): Blood sugar will be monitored, and medication dose adjustments made as needed; Cyclosporine: Dosage adjustments may be required to maintain therapeutic levels; Bromocriptine: Dose adjustments may be considered to account for absorption changes; Heart medications (e.g., beta blockers): Heart rate will be monitored, and medication doses adjusted if necessary; CYP3A4-metabolized medications: Dose adjustments may be considered to avoid increased exposure; In the opinion of the treating surgeon, based on preoperative data, the participant must not require a modified Appleby-type procedure (distal pancreatectomy with celiac axis resection) or multivisceral resection (e.g., stomach, colon, etc.) at the time of distal pancreatectomy; NOTE: planned removal of the gallbladder or spleen at the time of distal pancreatectomy is not considered multivisceral resection and is permissible; In the opinion of the treating surgeon, based on preoperative data, the participant must not require a tumor enucleation; Participants must not have moderate to severe hepatic impairment as defined by liver enzyme elevation more than 5 times the institutional upper limit of normal (either aspartate aminotransferase [AST] > 190 U/L or alanine aminotransferase [ALT] > 320 U/L) within 60 days prior to registration/randomization. Transient elevation at the time of screening that resolves prior to study enrollment is acceptable; Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped); Individuals who are of reproductive potential must have agreed to use an effective contraceptive method during the whole period of the study and for three months after the study drug administration, with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen; Participants must be offered the opportunity to participate in specimen banking; Participants who can complete EORTC QLQ-C30, EORTC QLQ-PAN26, and EQ-5D-5L forms in English or Spanish, must be offered the opportunity to participate in the quality-of-life study; NOTE: As a part of the OPEN registration process, the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system; Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines; For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations.

ClinicalTrials.gov NCT06807437