NCT07195734Toboroz2. fázis
Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
A Phase II Randomized Trial of Neoadjuvant Chemotherapy or Chemo-Immunotherapy in Patients With Recurrent/Persistent PD-L1 Enriched Squamous Cell Carcinoma of the Head and Neck Undergoing Salvage Surgery (NEOPOLIS)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 26.
Rövid összefoglaló (regiszter, angolul)
This phase II trial tests the addition of chemotherapy, with carboplatin and paclitaxel, or chemo-immunotherapy, with carboplatin, paclitaxel and cemiplimab to standard salvage surgery followed by post operative radiation therapy and cisplatin for high risk patients, for the treatment of patients with PD-L1 positive head and neck squamous cell carcinoma that has come back and spread to nearby tissue or lymph nodes after a period of improvement (locally recurrent) or is persistent. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Salvage surgery is surgery that takes place to remove tumor tissue after a failure of other treatment. High risk patients also receive radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Adding chemotherapy or chemo-immunotherapy to standard salvage surgery may kill more tumor cells than salvage surgery alone in patients with PD-L1 positive locally recurrent or persistent head and neck squamous cell carcinoma.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 180 (tervezett)
- Első benyújtás
- 2025. szept. 26.
- Kezdés
- 2026. ápr. 24.
- Elsődleges befejezés
- 2033. febr. 1.
- Fő szponzor
- National Cancer Institute (NCI)
- Betegségek
- Fej-nyaki daganatok
- NCT-szám
- NCT07195734
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 180
- 2026. ápr. 24. és az elsődleges befejezés (2033. febr. 1.) között
- 115 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Kiket keres a vizsgálat
- Pathologically (histologically or cytologically) proven diagnosis of locally recurrent or persistent squamous cell carcinoma of head and neck (SCCHN) arising within the oral cavity, oropharynx, larynx, or hypopharynx
- PD-L1 combined positive score (CPS) ≥ 1 using a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory
- Verify insurance (or other payment) coverage for neoadjuvant chemotherapy
- Measurable disease as defined by RECIST 1.1
- Patients must have locally recurrent or persistent SCCHN arising within the oral cavity, oropharynx, larynx, or hypopharynx (American Joint Committee on Cancer [AJCC] Cancer Staging Manual, 8th Edition) AND are deemed candidates for salvage surgery:
- P16 positive oropharynx patients with T2, T3, T4, N0, N1, N2 and all other patients with T2, T3, T4a, N0, N1, N2a, N2b, N2c, N3a are eligible.
- Patients must be deemed surgically resectable without gross residual disease.
- For patients with oral cavity SCCHN, only those with recurrent or persistent disease after prior surgery are eligible.
- Patients who are candidates for salvage laryngectomy to treat recurrent laryngeal cancer and who are having salvage surgery for curative intent are eligible.
- Patients with resectable lymph node-only recurrence are eligible.
- No major vascular involvement (> 180° involvement of the common carotid or internal carotid artery), jugular foramen involvement, or prevertebral, paraspinous muscle involvement precluding a curative resection
- No evidence of distant metastatic disease
- The following minimum diagnostic workup is required:
- General history and physical examination.
- Diagnostic-quality neck CT and PET/CT of neck (PET with attenuation-correction CT of neck, chest, and abdomen)
- Age ≥ 18
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Negative urine or serum pregnancy test (in persons of childbearing potential) within 30 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
- Platelets ≥ 100,000 cells/mm\^3
- Hemoglobin ≥ 8.0 g/dL (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] ≥ 8.0 g/dL is acceptable)
- Adequate renal function defined as creatinine clearance (CrCL) > 50 mL/min by the Cockcroft-Gault formula
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (Not applicable to patients with known Gilbert's syndrome)
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 x institutional ULN
- Only patients who received prior radiation therapy in the definitive or post-operative setting (limited to one course) are eligible.
- Prior radiation therapy must have been completed at least 6 months prior to registration with the majority of the index persistent/recurrent cancer volume (> 50%) irradiated to ≥ 40 Gy at the time
- Prior systemic therapy including immunotherapy with anti-PD1 or anti-PDL1 within the definitive setting (neo-adjuvant, or adjuvant) is permitted and must have been completed at least 4 months prior to registration
- Prior systemic therapy including immunotherapy for treatment of recurrent or metastatic SCCHN is not permitted
- No investigational anti-cancer agents received within 4 weeks prior to registration
- No New York Heart Association Functional Classification III or IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification)
- No active infection requiring IV antibiotics, IV antiviral, or IV antifungal treatments
- No peripheral neuropathy grade 3 or 4
- No history of interstitial lung disease
- No active, noninfectious pneumonitis requiring immunosuppressive therapy
- No history of a solid organ transplant (other than corneal transplant)
- No active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease-modifying agents, corticosteroids [> 10 mg prednisone/day or equivalent] or immunosuppressive drugs)
- NOTE: Patients meeting the following criteria are not considered immunosuppressed and are eligible to enroll:
- Patients who require a brief course of steroids (e.g., prophylaxis for imaging assessments due to hypersensitivity to contrast agents) are not excluded
- Patients with type I diabetes mellitus, and endocrinopathies (including hypothyroidism due to autoimmune thyroiditis) only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
- Physiologic replacement doses ≤ 10 mg prednisone/day or equivalent are allowed. Inhaled or topical steroids are permitted
- No history of allergic reaction to the study agent, compounds of similar chemical or biologic composition to the study agent, and immune checkpoint inhibitors (or any of its excipients)
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (115)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| UI Health Care Mission Cancer and Blood - Ankeny Clinic | Ankeny | Egyesült Államok | Toboroz |
| University of Michigan Rogel Cancer Center | Ann Arbor | Egyesült Államok | Toboroz |
| Emory Proton Therapy Center | Atlanta | Egyesült Államok | Toboroz |
| Emory University Hospital Midtown | Atlanta | Egyesült Államok | Toboroz |
| LSU Health Baton Rouge-North Clinic | Baton Rouge | Egyesült Államok | Toboroz |
| Our Lady of The Lake | Baton Rouge | Egyesült Államok | Toboroz |
| Our Lady of the Lake Physician Group | Baton Rouge | Egyesült Államok | Toboroz |
| Lafayette Family Cancer Center-EMMC | Brewer | Egyesült Államok | Toboroz |
| University of Michigan - Brighton Center for Specialty Care | Brighton | Egyesült Államok | Toboroz |
| Cooper Hospital University Medical Center | Camden | Egyesült Államok | Toboroz |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | Egyesült Államok | Toboroz |
| Medical University of South Carolina | Charleston | Egyesült Államok | Toboroz |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | Egyesült Államok | Toboroz |
| Northwestern University | Chicago | Egyesült Államok | Toboroz |
| Rush MD Anderson Cancer Center | Chicago | Egyesült Államok | Toboroz |
| Siteman Cancer Center at Saint Peters Hospital | City of Saint Peters | Egyesült Államok | Toboroz |
| Clackamas Radiation Oncology Center | Clackamas | Egyesült Államok | Toboroz |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic | Clive | Egyesült Államok | Toboroz |
| Atrium Health Cabarrus/LCI-Concord | Concord | Egyesült Államok | Toboroz |
| Methodist Jennie Edmundson Hospital | Council Bluffs | Egyesült Államok | Felfüggesztve |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Egyesült Államok | Toboroz |
| Carle at The Riverfront | Danville | Egyesült Államok | Toboroz |
| Northwestern Medicine Cancer Center Kishwaukee | DeKalb | Egyesült Államok | Toboroz |
| UI Health Care Mission Cancer and Blood - Laurel Clinic | Des Moines | Egyesült Államok | Toboroz |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic | Des Moines | Egyesült Államok | Toboroz |
| Broadlawns Medical Center | Des Moines | Egyesült Államok | Toboroz |
| Mercy Medical Center - Des Moines | Des Moines | Egyesült Államok | Toboroz |
| Iowa Methodist Medical Center | Des Moines | Egyesült Államok | Toboroz |
| Wayne State University/Karmanos Cancer Institute | Detroit | Egyesült Államok | Toboroz |
| Henry Ford Hospital | Detroit | Egyesült Államok | Toboroz |
| Carle Physician Group-Effingham | Effingham | Egyesült Államok | Toboroz |
| Saint Vincent Hospital | Erie | Egyesült Államok | Toboroz |
| UPMC Hillman Cancer Center Erie | Erie | Egyesült Államok | Toboroz |
| Weisberg Cancer Treatment Center | Farmington Hills | Egyesült Államok | Toboroz |
| UPMC Cancer Center at UPMC Horizon | Farrell | Egyesült Államok | Toboroz |
| Northwestern Medicine Cancer Center Delnor | Geneva | Egyesült Államok | Toboroz |
| Northwestern Medicine Glenview Outpatient Center | Glenview | Egyesült Államok | Toboroz |
| Northwestern Medicine Grayslake Outpatient Center | Grayslake | Egyesült Államok | Toboroz |
| Legacy Mount Hood Medical Center | Gresham | Egyesült Államok | Toboroz |
| IRMC Cancer Center | Indiana | Egyesült Államok | Toboroz |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care | Irvine | Egyesült Államok | Toboroz |
| University of Mississippi Medical Center | Jackson | Egyesült Államok | Toboroz |
| Jefferson Hospital | Jefferson Hills | Egyesült Államok | Toboroz |
| Jersey City Medical Center | Jersey City | Egyesült Államok | Toboroz |
| University of Wisconsin Carbone Cancer Center - Johnson Creek | Johnson Creek | Egyesült Államok | Toboroz |
| UPMC-Johnstown/John P. Murtha Regional Cancer Center | Johnstown | Egyesült Államok | Toboroz |
| University of Kansas Cancer Center | Kansas City | Egyesült Államok | Toboroz |
| University of Kansas Cancer Center - North | Kansas City | Egyesült Államok | Toboroz |
| University of Kansas Cancer Center - Briarcliff | Kansas City | Egyesült Államok | Toboroz |
| Gundersen Lutheran Medical Center | La Crosse | Egyesült Államok | Toboroz |
| Northwestern Medicine Lake Forest Hospital | Lake Forest | Egyesült Államok | Toboroz |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | Egyesült Államok | Toboroz |
| University of Kansas Cancer Center - Lee's Summit | Lee's Summit | Egyesült Államok | Toboroz |
| Rush MD Anderson Cancer Center at Rush Lisle | Lisle | Egyesült Államok | Toboroz |
| Cooperman Barnabas Medical Center | Livingston | Egyesült Államok | Toboroz |
| Monmouth Medical Center | Long Branch | Egyesült Államok | Toboroz |
| USC / Norris Comprehensive Cancer Center | Los Angeles | Egyesült Államok | Toboroz |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center | Madison | Egyesült Államok | Toboroz |
| University of Wisconsin Carbone Cancer Center - University Hospital | Madison | Egyesült Államok | Toboroz |
| Carle Physician Group-Mattoon/Charleston | Mattoon | Egyesült Államok | Toboroz |
| Froedtert Menomonee Falls Hospital | Menomonee Falls | Egyesült Államok | Toboroz |
| Medical College of Wisconsin | Milwaukee | Egyesült Államok | Toboroz |
| Forbes Hospital | Monroeville | Egyesült Államok | Toboroz |
| UPMC Hillman Cancer Center - Monroeville | Monroeville | Egyesült Államok | Toboroz |
| UPMC Cancer Center - Monroeville | Monroeville | Egyesült Államok | Toboroz |
| Vanderbilt University/Ingram Cancer Center | Nashville | Egyesült Államok | Toboroz |
| Rutgers New Jersey Medical School | Newark | Egyesült Államok | Toboroz |
| Providence Newberg Medical Center | Newberg | Egyesült Államok | Toboroz |
| Froedtert and MCW Moorland Reserve Health Center | New Berlin | Egyesült Államok | Toboroz |
| Rutgers Cancer Institute of New Jersey | New Brunswick | Egyesült Államok | Toboroz |
| Northwestern Medicine Oak Brook | Oak Brook | Egyesült Államok | Toboroz |
| Drexel Town Square Health Center | Oak Creek | Egyesült Államok | Toboroz |
| University of Oklahoma Health Sciences Center | Oklahoma City | Egyesült Államok | Toboroz |
| Nebraska Cancer Specialists/Oncology Hematology West PC - MECC | Omaha | Egyesült Államok | Toboroz |
| Nebraska Methodist Hospital | Omaha | Egyesült Államok | Toboroz |
| UC Irvine Health- Chao Family Comprehensive Cancer Center | Orange | Egyesült Államok | Toboroz |
| Providence Willamette Falls Medical Center | Oregon City | Egyesült Államok | Toboroz |
| Northwestern Medicine Orland Park | Orland Park | Egyesült Államok | Toboroz |
| University of Kansas Cancer Center-Overland Park | Overland Park | Egyesült Államok | Toboroz |
| Stanford Cancer Institute Palo Alto | Palo Alto | Egyesült Államok | Toboroz |
| Thomas Jefferson University Hospital | Philadelphia | Egyesült Államok | Toboroz |
| UPMC-Shadyside Hospital | Pittsburgh | Egyesült Államok | Toboroz |
| UPMC-Saint Clair Hospital Cancer Center | Pittsburgh | Egyesült Államok | Toboroz |
| UPMC Hillman Cancer Center | Pittsburgh | Egyesült Államok | Toboroz |
| Allegheny General Hospital | Pittsburgh | Egyesült Államok | Toboroz |
| UPMC-Saint Margaret | Pittsburgh | Egyesült Államok | Toboroz |
| Providence Portland Medical Center | Portland | Egyesült Államok | Toboroz |
| Providence Saint Vincent Medical Center | Portland | Egyesült Államok | Toboroz |
| Legacy Good Samaritan Hospital and Medical Center | Portland | Egyesült Államok | Toboroz |
| University of Rochester | Rochester | Egyesült Államok | Toboroz |
| Sutter Medical Center Sacramento | Sacramento | Egyesült Államok | Toboroz |
| University of California Davis Comprehensive Cancer Center | Sacramento | Egyesült Államok | Toboroz |
| UPMC Cancer Center at UPMC Northwest | Seneca | Egyesült Államok | Toboroz |
| Memorial Hospital East | Shiloh | Egyesült Államok | Toboroz |
| Siteman Cancer Center at Christian Hospital | St Louis | Egyesült Államok | Toboroz |
| Siteman Cancer Center-South County | St Louis | Egyesült Államok | Toboroz |
| Washington University School of Medicine | St Louis | Egyesült Államok | Toboroz |
| Stony Brook University Medical Center | Stony Brook | Egyesült Államok | Toboroz |
| ProMedica Flower Hospital | Sylvania | Egyesült Államok | Toboroz |
| Community Medical Center | Toms River | Egyesült Államok | Toboroz |
| Legacy Meridian Park Hospital | Tualatin | Egyesült Államok | Toboroz |
| University of Arizona Cancer Center-North Campus | Tucson | Egyesült Államok | Toboroz |
| Banner University Medical Center - Tucson | Tucson | Egyesült Államok | Toboroz |
| Carle Cancer Center | Urbana | Egyesült Államok | Toboroz |
| Legacy Salmon Creek Hospital | Vancouver | Egyesült Államok | Toboroz |
| Legacy Cancer Institute Medical Oncology and Day Treatment | Vancouver | Egyesült Államok | Toboroz |
| Northwestern Medicine Cancer Center Warrenville | Warrenville | Egyesült Államok | Toboroz |
| UPMC Cancer Center-Washington | Washington | Egyesült Államok | Toboroz |
| UPMC Washington Hospital Radiation Oncology | Washington | Egyesült Államok | Toboroz |
| UI Health Care Mission Cancer and Blood - Waukee Clinic | Waukee | Egyesült Államok | Toboroz |
| Wilmot Cancer Institute at Webster | Webster | Egyesült Államok | Toboroz |
| Froedtert West Bend Hospital/Kraemer Cancer Center | West Bend | Egyesült Államok | Toboroz |
| University of Kansas Hospital-Westwood Cancer Center | Westwood | Egyesült Államok | Toboroz |
| Wexford Health and Wellness Pavilion | Wexford | Egyesült Államok | Toboroz |
| Asplundh Cancer Pavilion | Willow Grove | Egyesült Államok | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.