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Accelerated Fractionation Radiotherapy (AFRT) Versus Concurrent Chemoradiotherapy (Crt) In Locally Advanced Head And Neck Squamous Cell Carcinoma

NCT01291095 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2011-03-04

No results posted yet for this study

Summary

The aim of this trial is to compare the accelerated fractionation radiotherapy and concurrent chemo-radiotherapy in locally advanced head and neck squamous cell carcinoma patients in terms of loco-regional control, toxicities and quality of life.

Conditions

Interventions

DRUG

CISPLATIN

IN CRT ARM:RADIATION ONE FRACTION PER DAY, ON FIVE CONSECUTIVE DAYS FROM MONDAY TO FRIDAY ALONG WITH INTRAVENOUS CISPLATIN 40mg/m2 WEEKLY FOR SEVEN DOSES. IN AFRT ARM: PATIENTS WILL NOT RECEIVE ANY CHEMOTHERAPY WITH CISPLATIN

RADIATION

EXTERNAL BEAM RADIOTHERAPY

Patients assigned to CRT arm will be given radiation one fraction per day, on five consecutive days from Monday to Friday along with intravenous cisplatin 40 mg/m2 weekly for seven doses (a minimum of 5weekly chemotherapy). Patients assigned to AFRT arm will undergo radiation similarly one fraction per day and then the sixth fraction will be given on another day (Saturday) or as an extra fraction on one of the first five days, but always allowing at least a 6-hour interval between fractions on same day. If any unintended interruption of the treatment occurs, this missing treatment will be given as soon as possible, preferably within a week, but not allowing more than 14 Gy to be given during any 7-day period.

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • Dr SUDEEP DAS, MBBS · ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI, INDIA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-07-31
Completion
2012-12-31

Countries

  • India

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01291095 on ClinicalTrials.gov