A Randomized controlled study to evaluate accelerated fractionation(6days/week radiation) with standard best practice(5days/week radiation) in Head and Neck cancers with weekly Concurrent chemotherapy in both arm
Phase 3
- Conditions
- Health Condition 1: null- Histologically proven case of Head and Neck Cancer
- Registration Number
- CTRI/2013/02/003410
- Lead Sponsor
- ICMR concept of proposal accepted
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
a. Informed consent
b.Karnofsky performance scale between 70-100
c. Histologic proof of squamous cell carcinoma of larynx, oropharynx or hypopharynx, that is treatment naïve.
d.Stage IIâ??IVA.
e.No evidence of distant metastases {Chest X ray, USG abdomen or PETCT(optional).
f. a. No prior radiation treatment to the head and neck or any prior chemotherapy.
Exclusion Criteria
a.Synchronous malignancy
b. Comobid condition like acute infections, chronic diseases such as renal, heart, liver (except Diabetes, Hypertension or Asthma).
c.Any condition that in the Investigators opinion may impact the safety of the procedure.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the therapeutic gain(efficacy) in terms Loco-regional control of accelerated treatment (6fraction/week) along with concurrent chemotherapy as compared to standard Radiotherapy of 5 fraction per week and concurrent chemotherapy in patients with head and neck cancersTimepoint: At 2 years
- Secondary Outcome Measures
Name Time Method Impact of quality of life of this accelerated chemoradiation with EORTC H& N 35 Quality of life questionnaireTimepoint: At treatment completion and subsequent follow up;To assess the tolerability of 6 days of radiotherapy and chemotherapy (acute and late toxicity).Timepoint: At treatment completion and subsequent follow up;To evaluate the therapeutic gain in terms of disease free survival and overall survival.Timepoint: At 2 years