Clinical trial · Interventional
Cetuximab and Combination Chemotherapy in Patients With Stage III-IV Resectable Oropharynx Cancer
Induction Chemotherapy With Cetuximab, Docetaxel, Cisplatin, and Fluorouracil (ETPF) in Patient With Resectable Stage III-IV Squamous Cell Carcinoma of the Oropharynx
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with cetuximab may kill more tumor cells. PURPOSE: This phase II clinical trial is studying how well cetuximab given together with combination chemotherapy works in treating patients with stage III or stage IV oropharynx cancer that can be removed by surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- cetuximab
- description
- Cetuximab by intravenous (IV) infusion over 1-2 h on day
- interventionNames
- Drug: cisplatin
- Drug: docetaxel
- Drug: fluorouracil
- Drug: Cetuximab
Primary outcomes (1)
- measure
- Clinical and Radiological Complete Clinical Response (crCR) Rate at 3 Months
- timeFrame
- at 3 months after ETPF combination
- description
- The evaluation of tumor response rate was assessed by computed tomography scan of the neck and chest at Baseline, then at 3 months from inclusion using RECIST1.0 criteria and clinical examination
Secondary outcomes (5)
- measure
- Complete Clinical Response (cCR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the oropharynx * Stage III (T3 or T1-2, N1-2, M0) or nonmetastatic stage IV (T4 or T1-3, N3, M0) disease * Resectable disease * Measurable or evaluable disease * Tumor tissue available PATIENT CHARACTERISTICS: Inclusion criteria: * WHO performance status 0-1 * ANC ≥ 1,500/mm3 * Platelet count ≥ 100,000/mm3 * Hemoglobin ≥ 9 g/dL * Creatinine \< 1.5 times upper limit of normal (ULN) * Creatinine clearance ≥ 60 mL/min * AST and ALT \< 5 times ULN * Bilirubin \< 1.5 times ULN * Not pregnant or nursing * Fertile patients must use effective contraception * Affiliated with social security (including CMU) Exclusion criteria: * Cardiovascular accident (myocardial infarction, cerebral vascular accident) within the past 6 months * Serious and/or uncontrolled cardiac or respiratory disease (pulmonary fibrosis, interstitial pneumopathy) * Other cancer within the past 5 years except for resected skin cancer, localized cutaneous or totally resected melanoma, or resected carcinoma in situ of the cervix * Auditory condition precluding the use of cisplatin * Contraindication due to psychological, social, or geographical reasons that may impede proper monitoring of treatment * Persons under guardianship or trusteeship, or prisoners of law PRIOR CONCURRENT THERAPY: * No prior treatment, including chemotherapy or radiotherapy * No concurrent phenytoin, live attenuated vaccines, or parenteral aminoglycosides
References
Publications (1)
- RESULTChibaudel B, Lacave R, Lefevre M, Soussan P, Antoine M, Perie S, Belloc JB, Banal A, Albert S, Chabolle F, Ceruse P, Baril P, Gatineau M, Housset M, Moukoko R, Benetkiewicz M, de Gramont A, Bonnetain F, Lacau St Guily J. Induction therapy with cetuximab plus docetaxel, cisplatin, and 5-fluorouracil (ETPF) in patients with resectable nonmetastatic stage III or IV squamous cell carcinoma of the oropharynx. A GERCOR phase II ECHO-07 study. Cancer Med. 2015 May;4(5):721-31. doi: 10.1002/cam4.408. Epub 2015 Feb 14. PMID 25684313