We are comparing two arm of treatment ,compare short course palliative Radiotherapy with short course concurrent palliative Chemotherapy plus radiotherapy in advanced and unresectable head and neck cancer .
Phase 2
- Conditions
- Health Condition 1: null- Head and Neck Cancer
- Registration Number
- CTRI/2012/06/002717
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
A Biopsy proven Squamous cell carcinoma of the Head and Neck region.
B ECOG Performance Status of 1/2/3.
C T4b and /or N3 TUMOUR that had been unanimously defined as inoperable and incurable by multidisciplinary team members.
D Sites â??oral cavity, oropharynx, hypopharynx.
Exclusion Criteria
A Patients with ECOG PS 4
B Non-squamous histology.
C H/o previous malignancy at same or other site.
D Patients who has received Radiotherapy or Chemotherapy in the past either from IRCH or from other centre.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To assess locoregional disease control at 6 months between patients with short course palliative Radiotherapy PRT versus patients with short course concurrent palliative Chemotherapy plus radiotherapy CTRT in advanced and unresectable head and neck cancer. <br/ ><br>2.Proportion of patients eligible for radical RT versus radical CT and RT in each treatment arm. <br/ ><br>Timepoint: 6 months from the date of randomization.
- Secondary Outcome Measures
Name Time Method 1. To assess for degree of symptom relief & palliation between two groups. <br/ ><br>2. To compare progression free survival and overall survival between two groups <br/ ><br>3. To compare toxicity between two groups. <br/ ><br>Timepoint: at one month and six month.