Randomised trial to study the additional impact of brachytherapy (internal radiation) over high precision external radiotherapy for reduction of dryness of mouth in patients with early stage cancer of oropharynx.
Phase 3
- Conditions
- Health Condition 1: null- head and neck cancers
- Registration Number
- CTRI/2010/091/001329
- Lead Sponsor
- Tata Memorial CentreDAECTC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 157
Inclusion Criteria
1.Patients with OPC
2.Willing for definitive treatment at TMH
3.Early stage T1-2N0M0
4.Squamous cell carcinoma
5.Age>18
6.Fit for radical treatment
7.Karnofsky Performance score >60
8.No prior history of therapeutic irradiation
9.Normal liver and renal functiontests.
10.Informed Consent
11.Tumor topology suitable for BT
12.Willing for follow up and follow up investigations
Exclusion Criteria
1.Patients unfit for BT procedure due to medical comorbidities
2.Advanced stage T3,4/N1-3/M1 disease
3.Prior history of malignancy
4.Pregnancy and lactating women
5.Non squamous histology
6.Tumor topology not suitable for BT.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in the xerostomia evaluated at 6 months.Timepoint: NA;To compare the local control rates, disease free and overall survival in two two groups.Timepoint: NA;To study quality of life in the two groups.<br><br>To assess reduction in doses to constrictirs and larynx with the two modalities.Timepoint: NA
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI