RecruitingPhase 2NCT02290145

Cyclin D1 Based TPF Induction Chemotherapy for Oral Squamous Cell Carcinoma Patients at Clinical N2 Stage

Cyclin D1 Based TPF(Docetaxel, Cisplatin and 5-fluorouracil) Induction Chemotherapy for OSCC(Oral Squamous Cell Carcinoma) Patients at cN2(Clinical Node 2) Stage: a Phase II Randomized Controlled Trial


Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

48 participants

Start Date

Dec 1, 2016

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to To confirm the predictive value of CCND1 for TPF induction in cN2 patients with OSCC


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether a specific protein marker (Cyclin D1) in tumors can help predict which oral cancer patients will respond best to a three-drug chemotherapy combination (called TPF) given before surgery or radiation. **You may be eligible if...** - You are between 18 and 75 years old - You have been confirmed by biopsy to have squamous cell carcinoma (a common type of cancer) in your mouth or oral cavity - Your tumor shows high expression of the Cyclin D1 protein - Your cancer is at clinical stage III or IVA with lymph node involvement (N2) and can be surgically removed - Your blood counts and organ function meet the required levels **You may NOT be eligible if...** - Your cancer is at a different stage or location - Your Cyclin D1 expression is low - Your general health or organ function is too poor for chemotherapy - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTPF group

The patients in the experimental group received the TPF induction chemotherapy for 2 cycles followed by radical surgery and post-operative radiotherapy. docetaxel:75mg/m2 cisplatin:75 mg/m2 5-Fu:750 mg/m2/day

PROCEDUREsurgery group

The patients in the control group received the radical surgery and post-operative radiotherapy.

RADIATIONPost-operative radiotherapy

Radiotherapy was arranged 4 to 6 weeks after surgery. Routine external beam radiotherapy, such as conformal or intensity modulated radiotherapy was performed, and the dose was 1.8-2 Gy/day, 5 days/week for 6 weeks, and totally 54-60 Gy.


Locations(1)

Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

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NCT02290145


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