CompletedPhase 2

Cetuximab and Combination Chemotherapy in Patients With Stage III-IV Resectable Oropharynx Cancer

France42 participantsStarted 2008-02-01

Plain-language summary

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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 aminoglycoside…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical and Radiological Complete Clinical Response (crCR) Rate at 3 Months

Timeframe: at 3 months after ETPF combination

Trial details

NCT IDNCT00665392

SponsorGERCOR - Multidisciplinary Oncology Cooperative Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-02-01

Results submitted2016-12-21

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