Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors
A legfontosabb adatok
- Ki végzi
- Children's Oncology Group
- Hol
- Calgary, Edmonton, Halifax, Hamilton, Kingston, London, Montreal, Ottawa, Québec, Sherbrooke, St. John's, Toronto, Vancouver és Winnipeg (Kanada)Mind a 17 helyszín megnézéseMég 8 másik országban, 612 helyszínen
- Azonosító
- Állapot
- Toboroz
- Fázis
- 3. fázis
- Résztvevők
- 1780 fő, tervezett
- Kezdés
- 2017. máj. 25.
- Várható befejezés
- 2027. jún. 30.
- A vizsgálat típusa
- Beavatkozással járó, 5 csoport
- A vizsgált kezelések
- Best Practice
- Biopsy Procedure
- Biospecimen Collection
- Bleomycin Sulfate
- Carboplatin
- Cisplatin
- Computed Tomography
- Etoposide
- Magnetic Resonance Imaging
- Pulmonary Function Test
- Questionnaire Administration
- A regiszteradat frissítve
- 2026. augusztus 25.
Ki vehet részt
MI-összefoglaló
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 újonnan diagnosztizált csírasejtes daganatban szenvedő gyermekeket és felnőtteket keres. Az I. stádiumú, alacsony kockázatú daganatokat a műtét után megfigyelik. A magasabb stádiumú daganatokat karboplatinnal vagy ciszplatinnal kezelik.
- Életkor
- Alacsony kockázatú I. stádiumú daganat: bármely életkor. 1. standard kockázat: 11 évesnél fiatalabb. 2. standard kockázat: 11 évtől 25 évesnél fiatalabbig.
- Nem
- Nemtől függetlenül bárki csatlakozhat.
- A betegség stádiuma
- Újonnan diagnosztizált, agyon kívüli csírasejtes daganat. Alacsony kockázat: I. stádiumú petefészek éretlen teratóma, I. stádiumú nem-szeminóma vagy I. stádiumú hererák szeminóma. Standard kockázat: II. vagy magasabb stádiumú rosszindulatú csírasejtes daganat a petefészekben, a hererben vagy a nemi szerveken kívül.
- Korábbi kezelés
- Nem lehetett korábban kemoterápia vagy más egész testre ható kezelés ennek a daganatnak a miatt. Sugárkezelés sem lehetett, kivéve az agyi áttétek besugárzását az 1. standard kockázatnál.
- Biomarker vagy leletérték
- A 11 évtől 25 évesnél fiatalabb korcsoportban a heredaganatnak jó kockázatúnak kell lennie. A műtét után az alfa-FP < 1,000 ng/mL, a béta-HCG < 5,000 IU/mL és az LDH < 3.0 x normál érték.
A részvétel fő kizáró okai
- A tiszta szeminóma nem csatlakozhat a standard kockázatú ágakhoz
- Tiszta érett teratóma, vagy tiszta éretlen teratóma 1000 ng/mL vagy magasabb AFP-vel
- Rossz kockázatú csírasejtes daganat, vagy az agy elsődleges csírasejtes daganata
- A bleomicin használatát kizáró tüdőbetegség (standard kockázatú ágak)
- Terhes vagy szoptató betegek, akik kemoterápiát kapnának
A regiszter feltételei, szó szerint
Mind a 32 feltétel megnézéseKevesebb
Ki vehet részt
- There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT [all sites])
- Standard risk 1: Patients must be < 11 years of age at enrollment
- Standard risk 2: Patients must be >= 11 and < 25 years of age at enrollment
- Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with malignant germ cell tumor (stage II or higher); Histologic confirmation of a primary extracranial germ cell tumor in any of the categories outlined below is required of all patients at enrollment , with the following exceptions:; Among patients were initially diagnosed with completely resected non-seminoma malignant GCT and later recur during observation post surgery, a diagnostic biopsy is not required for enrollment if elevated tumor markers rise to > 5 x upper limit of normal (ULN) on at least 2 measurements taken at least 1 week apart. The pathology report of initial surgery should be provided; Patients may be enrolled without histologic or cytologic confirmation in the rare case where there are exceptionally raised tumor markers (alpha fetoprotein [AFP- ≥ 500 ng/mL or HCG ≥ 500 IU/L) and radiologic features consistent with GCT. In addition, the treating clinician must deem that the patient's tumor is not suitable for upfront resection and that a biopsy is not in the patient's best interest; or that there is a need to start therapy urgently
- Low risk immature teratoma (IT); site: ovarian; stage: any; grade: any; histology: pure immature teratoma, mixed immature and mature teratoma, (may contain microscopic foci of yolk sac tumor [< 3 mm], but no other pathological evidence of MGCT); tumor markers: alpha-FP =< 1,000 ng/mL, beta-HCG institutional normal; all ages
- Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB, American Joint Committee on Cancer (AJCC) testicular stage IA, IB and IS; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages
- Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; AJCC testicular stage IA IB, and IS; histology: must contain only seminoma; may contain immature/mature teratoma; may NOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages
- Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV, FIGO stage IC-IV, (International Germ Cell Consensus Classification [IGCCC] criteria DO NOT apply); histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) < 11
- Standard risk 2 (SR2); Site: ovarian; stage: COG stage II, III, and III-X, FIGO stage IC, II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) >= 11 and < 25; Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma: must be IGCCC good risk; post op: alpha-FP < 1,000 ng/mL, beta-HCG < 5,000 IU/mL and lactate dehydrogenase (LDH) < 3.0 x normal; age (years) >= 11 and < 25
- Notes:; IGCCC criteria only apply to SR2 patients with a testicular primary tumor; Use post-op tumor marker levels to determine IGCCC risk group; Pure seminoma patients are not eligible for the standard risk arms of the study; For the low risk stage I non-seminoma MGCT and the standard risk arms, components of yolk sac tumor, embryonal carcinoma, or choriocarcinoma can be mixed with other forms of GCT, such as seminoma or mature or immature teratoma; if yolk sac tumor is the only malignant component present, then it must be deemed by the pathologist to be greater than a "microscopic component" of yolk sac tumor
- Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, 2 or 3; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
- Organ function requirements apply ONLY to patients who will receive chemotherapy (SR1 and SR2 patients)
- Adequate renal function defined as:
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m\^2 (within 7 days prior to enrollment) OR
- A serum creatinine based on age/sex as follows (within 7 days prior to enrollment): (mg/dL); 1 month to < 6 months male: 0.4 female: 0.4; 6 months to < 1 year male: 0.5 female: 0.5; 1 to < 2 years male: 0.6 female: 0.6; 2 to < 6 years male: 0.8 female: 0.8; 6 to < 10 years male: 1 female: 1; 10 to < 13 years male: 1.2 female: 1.2; 13 to < 16 years: male: 1.5 female: 1.4; >= 16 years male: 1.7 female: 1.4
- Total bilirubin =< 2 x upper limit of normal (ULN) for age (within 7 days prior to enrollment); Unless due to Gilbert's disease, malignant involvement of liver or vanishing bile duct syndrome
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x upper limit of normal (ULN) (within 7 days prior to enrollment); Unless due to Gilbert's disease, malignant involvement of liver or vanishing bile duct syndrome
- Peripheral absolute neutrophil count (ANC) >= 750/mm\^3 (within 7 days prior to enrollment) AND
- Platelet count >= 75,000/mm\^3 (within 7 days prior to enrollment)
- Patients enrolling on the standard risk arms must be medically fit to receive protocol treatment and with no contraindications to protocol treatment
- Eligibility criteria to participate in the pilot study of the AYA-Hears instrument (patient reported outcomes [PROs] of ototoxicity) Note: participants in group 1 will not receive AGCT1531 protocol-directed therapy; all other AYA-HEARS patients must be enrolled on the AGCT1531 SR2 arm in order to participate
- >= 11 and < 25 years old at enrollment
- Able to fluently speak and read English
- Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor
- Followed for cancer or survivorship care at one of the following institutions:; Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center; Dana Farber/Harvard Cancer Center; Hospital for Sick Children; Children's Hospital of Eastern Ontario; Oregon Health and Science University; Seattle Children's Hospital; Yale University
Ki nem vehet részt
- Patients must have had no prior systemic therapy for the current cancer diagnosis
- Patients must have had no prior radiation therapy with the exception of CNS irradiation of brain metastases; (this exception only applies to SR1 patients; any patients over age 11 with distant metastases to brain [stage IV disease] would be considered poor risk and therefore not eligible for this trial)
- Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients])
- Lactating females who plan to breastfeed their infants; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients])
- Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients])
- Patients with significant, pre-existing co-morbid respiratory disease that contraindicate the use of bleomycin are ineligible for the standard risk arms of the trial
- Patients with any diagnoses not listed including:; Stage I testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection); Pure ovarian or extragonadal dysgerminoma/seminoma; Pure mature teratoma; Pure immature teratoma with alpha-fetoprotein (AFP) >= 1000 ng/mL; "Poor risk" GCT (age >= 11 years old and COG stage IV ovarian, COG stage II- IV extragonadal, or IGCCC intermediate or poor risk testicular), or; Primary central nervous system (CNS) germ cell tumor; Germ cell tumor with somatic malignant transformation; Spermatocytic seminoma
Helyszínek itt: Kanada
Még 8 másik országban, 612 helyszínen
- Alberta Children's HospitalCalgary, KanadaContact: Victor A. Lewis (principal investigator)Résztvevőt keres
- University of Alberta HospitalEdmonton, KanadaContact: Sarah J. McKillop (principal investigator)Résztvevőt keres
- IWK Health CentreHalifax, KanadaContact: Chelsea Ash (principal investigator)Résztvevőt keres
- McMaster Children's Hospital at Hamilton Health SciencesHamilton, KanadaContact: Uma H. Athale (principal investigator)Résztvevőt keres
- Kingston Health Sciences CentreKingston, KanadaContact: Laura Wheaton (principal investigator)Résztvevőt keres
- Children's HospitalLondon, KanadaContact: Shayna M. Zelcer (principal investigator)Résztvevőt keres
- Centre Hospitalier Universitaire Sainte-JustineMontreal, KanadaContact: Monia Marzouki (principal investigator)Résztvevőt keres
- The Montreal Children's Hospital of the MUHCMontreal, KanadaContact: Stephanie Mourad (principal investigator)Résztvevőt keres
- Children'S Hospital Of Eastern OntarioOttawa, KanadaContact: Donna L. Johnston (principal investigator)Résztvevőt keres
- CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)Québec, KanadaContact: Bruno Michon (principal investigator)Résztvevőt keres
- Centre Hospitalier Universitaire de Sherbrooke-FleurimontSherbrooke, KanadaContact: Josee Brossard (principal investigator)Résztvevőt keres
- Janeway Child Health CentreSt. John's, KanadaContact: Lisa A. Goodyear (principal investigator)Résztvevőt keres
- Hospital for Sick ChildrenToronto, KanadaContact: Furqan Shaikh (principal investigator)Résztvevőt keres
- Odette Cancer Centre, Sunnybrook Health Sciences CentreToronto, KanadaContact: Allan L. Covens (principal investigator)Résztvevőt keres
- University Health Network, Princess Margaret HospitalToronto, KanadaContact: Robert J. Hamilton (principal investigator)Résztvevőt keres
- British Columbia Children's HospitalVancouver, KanadaContact: Rebecca J. Deyell (principal investigator)Résztvevőt keres
- CancerCare ManitobaWinnipeg, KanadaContact: Stephanie M. Villeneuve (principal investigator)Résztvevőt keres
A vizsgálatról
Mit akar kideríteni a vizsgálat
This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Chemotherapy drugs, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic standard risk germ cell tumors.
A vizsgálat 5 csoportja
- Arm I (bleomycin, carboplatin, etoposide)A vizsgált kezelés
Patients receive bleomycin IV over 10 minutes and carboplatin IV over 1 hour on day 1. Patients also receive etoposide IV over 1-2 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.
Kezelés: Biopsy Procedure, Biospecimen Collection, Bleomycin Sulfate, Carboplatin, Computed Tomography, Etoposide, Magnetic Resonance Imaging, Pulmonary Function Test és Questionnaire Administration
- Arm II (bleomycin, etoposide, cisplatin)A vizsgált kezelés
Patients receive bleomycin IV over 10 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.
Kezelés: Biopsy Procedure, Biospecimen Collection, Bleomycin Sulfate, Cisplatin, Computed Tomography, Etoposide, Magnetic Resonance Imaging, Pulmonary Function Test és Questionnaire Administration
- Arm III (bleomycin, etoposide, carboplatin)A vizsgált kezelés
Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.
Kezelés: Biopsy Procedure, Biospecimen Collection, Bleomycin Sulfate, Carboplatin, Computed Tomography, Etoposide, Magnetic Resonance Imaging, Pulmonary Function Test és Questionnaire Administration
- Arm IV (bleomycin, etoposide, cisplatin)A vizsgált kezelés
Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.
Kezelés: Biopsy Procedure, Biospecimen Collection, Bleomycin Sulfate, Cisplatin, Computed Tomography, Etoposide, Magnetic Resonance Imaging, Pulmonary Function Test és Questionnaire Administration
- Low-Risk (observation)A vizsgált kezelés
Patients with low-risk stage I grade 2, 3 ovarian immature teratoma or stage I non-seminoma or seminoma MGCTs undergo observation and can transfer to standard risk arm when eligibility criteria are met. Patients with stage I seminoma testicular MGCT undergo observation, and those with residual/recurrent disease are treated at the discretion of their physician. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial.
Kezelés: Best Practice, Biopsy Procedure, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging és Questionnaire Administration
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients With Germ Cell Tumors
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 12.
- A regiszteradat frissítve
- 2026. augusztus 25.