PILOT Phase of a trial looking at benefits of Hyperfractionated IMRT in locally advanced head and neck cancer.
Phase 1
Completed
- Registration Number
- CTRI/2010/091/000428
- Lead Sponsor
- Chriatian Medical College , Vellore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 3
Inclusion Criteria
Age < 70 yrs
Squamous cell carcinoma of oropharynx or hypopharynx
T3, T4 and N0 or N+ and M0 / Stage III & Stage IV A and B
ECOG/ Performance score of 1 and 2
Hb > 8.0 mg/dL
Exclusion Criteria
History of prior irradiation to the loco-regional site
History of prior surgery or chemotherapy
ECOG/ Performance score of > 2
Prior and concomitant associated diseases which are contraindications to radiotherapy like connective tissue disorders.
Hb < 8.0 mg/dL
Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine whether Hyper fractionated IMRT in locally advanced T3 T4, N0 N+ squamous cell carcinoma of the oropharynx and hypopharynx leads to a reduction in acute toxicity as compared to the historical data from the standard fractionated intensity modulated chemo-radiotherapy.Timepoint: Week 1,2, 3 4 , 5, 6th, 6th week post radiotherapy, 6th month and end of first year
- Secondary Outcome Measures
Name Time Method econdary OutcomeTimepoints<br>? To evaluate the incidence of late effects, grade 3 and 4 Xerostomia and dysphagia during the first year following the treatment evaluated using CTC AE v 3.0. ? To assess the Quality of life (QoL) using EORTC head and neck module for QoL ? To assess the loco regional control at the end of first year following completion of therapy.Timepoint: Week 1,2, 3 4 , 5, 6th, 6th week post radiotherapy, 6th month and end of first year