A Randomized Trial comparing 6 ½ weeks radiotherapy treatment (66 Grey total radiation dose) combined with chemotherapy versus 5 weeks accelerated radiotherapy alone (67.5 Grey) in Stage III/IV (locally advanced ) Oropharyngeal cancers.
Phase 3
Completed
- Conditions
- Health Condition 1: null- CANCER
- Registration Number
- CTRI/2012/01/002369
- Lead Sponsor
- PGIMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1.Biopsy proven cases of squamous cell carcinoma of oropharynx with no prior cancer directed treatment.
2.Tumor staged as III/IV as per the AJCC staging system.
3.Patient with a Karnofsky performance score (10) of 70 and above.
4.Patient who sign the informed consent and are ready to be on follow up as required.
Exclusion Criteria
1.Age < 18 years or >70 years
2.Pregnant women
3.Prior invasive malignancy.
4.Patients with simultaneous primaries or bilateral tumors are excluded
5.N3 nodal status.
6.Uncontrolled co morbid conditions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method locoregional control, <br/ ><br>disease free survival,Timepoint: 6 MONTHS
- Secondary Outcome Measures
Name Time Method acute and late toxicity, <br/ ><br>Quality of lifeTimepoint: 6 MONTHS