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.

Phase 4

Completed

• Conditions: Head and Neck Squamous Cell Carcinoma
• Interventions: Drug: Cisplatin 40 mg/m2; Drug: Cisplatin 100 mg/m2

• Registration Number: NCT03998696
• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2018-06-30
• Study Completion: 2018-12-31
• Status Verified: 2019-06
• Study First Submitted: 2019-06-22
• Study First Submitted QC: 2019-06-25
• Study First Posted: 2019-06-26
• Last Update Submitted: 2019-06-26
• Last Update Posted: 2019-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weekly Cisplatin	Cisplatin 40 mg/m2	Inj. Cisplatin 40 mg /m2 intravenous infusion delivered concurrently with radiotherapy on a weekly basis.
Three weekly Cisplatin	Cisplatin 100 mg/m2	Inj. Cisplatin 100 mg/m2 intravenous infusion delivered on a three weekly basis on days 1, 22 and 43 delivered concurrently with radiotherapy.

Primary Outcome Measures

Name	Time	Method
Loco-regional tumor control after completion of treatment	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	8 months	National Cancer Institute's Common Terminology Criteria for Advanced Events (version 4.03) was used measure toxicities.

Trial Locations

Locations (1)

Bangabandhu Sheikh Mujib Medical University; 🇧🇩 Dhaka, Bangladesh