Status:
UNKNOWN
Oral Cancer Adjuvant Therapy (OCAT) Trial
Lead Sponsor:
Tata Memorial Hospital
Conditions:
Mouth Neoplasms
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
To demonstrate whether addition of Concurrent chemotherapy to post-operative adjuvant radiotherapy OR shortening of duration of post-operative radiotherapy, by administering 6 fractions / week instead...
Detailed Description
Locally advanced, stage III and IVA, resectable, squamous cell carcinomas of oral cavity are conventionally treated with surgery, followed by post-operative radiotherapy. Local-regional recurrence rem...
Eligibility Criteria
Inclusion
- Previously untreated, resectable, loco-regionally advanced, stage III \& IV, biopsy-proven squamous cell carcinoma of the oral cavity. (Clinically lower stage patients will also be included if upstaged to pathological stage III or IV after Surgery)
- One or more of the following must be present:
- extracapsular nodal extension, involvement of \> 2 regional lymph nodes, margin of resection with invasive cancer (on histopathology) Extensive soft tissue and / or skin infiltration requiring major reconstructive procedure.
- Peri-neural invasion with positive lymph node(s). Lymphovascular embolisation with positive lymph node(s). Age \> 18. Karnofsky performance status of \> 60. WBC \> 3500, platelets \> 100,000 Serum creatinine \< 1.2 mg / m2 Signed study-specific informed consent form. Protocol treatment must begin within 8 weeks surgery.
Exclusion
- Gross (visible or palpable) residual disease left after surgery. Prior chemotherapy or radiation therapy to the head and neck region.
- Evidence of distant metastasis. Any post-operative complication which will delay starting of adjuvant treatment for more than 8 weeks.
- Presence of synchronous or concurrent head and neck primary tumors. Prior malignancy within the previous 5 years. Patients who because of their medical status are not candidates for the proposed treatment.
- KPS \< 60. Age \> 65 years. Poor expected follow up.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2017
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT00193843
Start Date
June 1 2005
End Date
June 1 2017
Last Update
December 26 2005
Active Locations (1)
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1
Dr. Mandar. S. Deshpande, Tata Memorial Hospital, Parel
Mumbai, Maharashtra, India, 400012