An Experimental Study to Compare Treatment Response and Toxicities of Concurrent Chemoradiation With Weekly Cisplatin and Three Weekly Cisplatin in Locally Advanced Head and Neck Cancer.

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare treatment responses and toxicities of concurrent chemo-radiation with weekly and three weekly Cisplatin in locally advanced Head & Neck Cancer. Half of the participants received Cisplatin (40 mg/m2) weekly with radiotherapy, while the other half received Cisplatin (100 mg/m2) thrice weekly with radiotherapy. Radiotherapy continued five days per week for six and half weeks.

Official Title
-----------------
Comparison Between Two Regimens of Chemotherapy Concurrent With Radiotherapy in Locally Advanced Head and Neck Cancer

Conditions
-----------------
Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: Cisplatin 40 mg/m2
* Drug: Cisplatin 100 mg/m2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy proved, previously untreated, Squamous cell carcinoma of head & neck Stages III to IVB Exclusion Criteria: Patients with history of prior chemotherapy or radiotherapy to the head and neck region. Initial surgery (excluding diagnostic biopsy) of the primary site. Patients with synchronous primaries. Those who are not willing to be included in the study. Pregnant or lactating woman. Serious medical illness Prisoners.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Weekly Cisplatin<br>Inj. Cisplatin 40 mg /m2 intravenous infusion delivered concurrently with radiotherapy on a weekly basis. | Drug: Cisplatin 40 mg/m2<br>* Cisplatin 40 mg/m2, weekly, concurrent with Radiotherapy<br>|
| Experimental: Three weekly Cisplatin<br>Inj. Cisplatin 100 mg/m2 intravenous infusion delivered on a three weekly basis on days 1, 22 and 43 delivered concurrently with radiotherapy. | Drug: Cisplatin 100 mg/m2<br>* Cisplatin 100 mg/m2, three weekly, concurrent with Radiotherapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loco-regional tumor control after completion of treatment | Response Evaluation Criteria in Solid Tumors was used to measure outcome: Complete response (CR): Disappearance of all target lesions. Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions. Progressive disease (PD): At least a 20% increase in the sum of diameters of target lesions. Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. | 6 months | 
| Treatment related toxicities during and after treatment | National Cancer Institute's Common Terminology Criteria for Advanced Events (version 4.03) was used measure toxicities. | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Locally advanced, Head and Neck Cancer, Concurrent, Weekly Cisplatin, Three weekly Cisplatin, Radiotherapy