CompletedPhase 2/3

TPF Induction Chemotherapy for Locally Advanced and Resectable Oral Squamous Cell Carcinoma

China256 participantsStarted 2008-01

Plain-language summary

Induction chemotherapy is regarded as an effective way to reduce or downgrade the locally advanced or aggressive cancers, and to improve the chance of eradication of the locoregional lesions by radical surgery and/or radiotherapy. However, there are still debates on the clinical value of induction chemotherapy for patients with advanced and resectable oral squamous cell carcinoma. The hypothesis of this study is that the induction chemotherapy of TPF (docetaxel, cisplatin, and 5-fluorouracil) protocol could benefit the patients with locally advanced oral squamous cell carcinoma. The endpoints of this study are the survival rate, local control, and safety.

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.

Inclusion Criteria: * Written informed consent prior to any study activities * Age 18-75 years old * Histological biopsy confirming oral squamous cell carcinoma (tongue, gingiva, buccal mucosa, floor of mouth, palate, and retromolar region) * Clinical stage III/IVA (T1-2, N1-2, M0 or T3-4, N0-2, M0, UICC 2002), resectable lesions * Karnofsky performance status (KPS) \> 60 * Adequate hematologic function: white blood cell \> 3,000/mm\^3, hemoglobin \> 8g/L, platelet count \> 80,000/mm\^3 * Hepatic function: ALAT/ASAT \< 2.5 times the upper limit of normal (ULN), bilirubin \< 1.5 times ULN * Renal function: serum creatinine \< 1.5 x ULN * Life expectancy ≥ 6 months Exclusion Criteria: * Evidence of distant metastatic disease and other cancers * Surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy) before study treatment * Previous radiotherapy for the primary tumor or lymph nodes * Prior chemotherapy or immunotherapy for the primary tumor * Other previous malignancy within 5 years * Systematic diseases history of severe pulmonary or cardiac diseases * Creatinine Clearance \< 30 ml/min * Legal incapacity or limited legal capacity * Pregnancy (confirmed by serum or urine β-HCG) or lactation period

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

Survival rate

Timeframe: Up to 5 years

Trial details

NCT IDNCT01542931

SponsorShanghai Jiao Tong University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-12

View on ClinicalTrials.gov More Stage III Oral Cavity Squamous Cell Carcinoma trials