Comparison Between Two Regimens of Chemotherapy Concurrent With Radiotherapy in Locally Advanced Head and Neck Cancer
Overview
- Phase
- Phase 4
- Intervention
- Cisplatin 40 mg/m2
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Loco-regional tumor control after completion of treatment
- Status
- Completed
- Last Updated
- 6 years ago
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.
Investigators
Dr. Ishtiaq-Ur-Rahim
Principal Investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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.
Arms & Interventions
Weekly Cisplatin
Inj. Cisplatin 40 mg /m2 intravenous infusion delivered concurrently with radiotherapy on a weekly basis.
Intervention: Cisplatin 40 mg/m2
Three weekly Cisplatin
Inj. Cisplatin 100 mg/m2 intravenous infusion delivered on a three weekly basis on days 1, 22 and 43 delivered concurrently with radiotherapy.
Intervention: Cisplatin 100 mg/m2
Outcomes
Primary Outcomes
Loco-regional tumor control after completion of treatment
Time Frame: 6 months
Response Evaluation Criteria in Solid Tumors was used to measure outcome: 1. Complete response (CR): Disappearance of all target lesions. 2. Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions. 3. Progressive disease (PD): At least a 20% increase in the sum of diameters of target lesions. 4. Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Treatment related toxicities during and after treatment
Time Frame: 8 months
National Cancer Institute's Common Terminology Criteria for Advanced Events (version 4.03) was used measure toxicities.