Comparison of Response and Acute Toxicities of Concurrent Chemoradiation with Weekly Cisplatin Vs. Paclitaxel/Carboplatin in Locally Advanced Squamous Cell Carcinoma of Head & Neck: A Short-term Phase III Clinical Trial.

Phase 2

Conditions: C76.0
Head, face and neck

Registration Number: DRKS00012877

Lead Sponsor: Dr. Md Shuayb, MBBS, MSc, FCPS, Specialist, Oncology & Radiotherapy Centre, Square Hospitals Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 100

Inclusion Criteria

1) SCCHN proved by histopathology.
2) AJCC stage-III, IVA and IVB.
3) Age: 18 to 75.
4) Eastern Cooperative Oncology Group (ECOG) performance status = 2.
5) Biochemical tests values: WBC= 3.5×10^9/L, Neutrophils =1.5×10^9/L, Platelets =100×10^9/L, haemoglobin =9gm/dl, Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin =1.5×the upper limit of the institutional normal range, Creatinine concentration=120 umol/L, and creatinine clearance =50 ml/min.
6) No serious diseases of important organs.
7) Written informed consent signed prior to enrollment.

Exclusion Criteria

1) Prior chemotherapy or head & neck irradiation,
2) Pregnant or lactating woman,
3) Serious diseases (include significant cardiovascular disease or uncontrolled diabetes) of important organs,
4) Other malignancies,
5) Active uncontrolled infection,
6) Joined in other clinical trial,
7) Stage IVB with cricoid cartilage invasion.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
What: Treatment Response<br><br>When: 6 weeks after completion of Treatment<br><br>How: The treatment response evaluation will be performed according to the Response Evaluation Criteria in Solid Tumours (RECIST), version 1.1 as Complete response (CR), partial response (PR), progressive disease (PD), stable disease (SD) using the data of Panendoscopic evaluation and CT scans of neck & face obtained 6 weeks after therapy. Pathologic confirmation will be required for patients suspected to have clinical evidence of residual disease at the primary site 6 weeks after therapy.

Secondary Outcome Measures

Name	Time	Method
What: Acute toxicities<br><br>When: Weekly during treatment and 6 weeks after completion of treatment.<br><br>How: Acute toxicities of the two regimens will be evaluated by determining the frequency of severe (= grade 3) toxicities based on RTOG Acute Radiation Morbidity Criteria using the information of history and physical examinations, ECOG performance status, CBC, electrolyte, creatinine, SGPT.