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 .
- Conditions
- Head and Neck Cancer
- Registration Number
- CTRI/2012/06/002717
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Head and Neck cancer (HNSCC )patients present as advance and incurable stage in nearly 30-35% in India.These patients are neither suitable for surgery nor fit for curative RT or chemo-RT approaches.At the same time these advance HNSCC patients are not well defined in Western literature.These patients are similar to lung,Esophagus,Gall Bladder and need Palliative anti-cancer therapy and/or best supportive care.If adding concurrent IV bolus chemotherapy gives an added advantage over palliative RT with toxicities that are acceptable than it will have paradigm change in therapeutic modality in such a group of patients,which comprises nearly one third of HNSCC patients in a country with limited resources.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 100
- 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 –oral cavity, oropharynx, hypopharynx.
- 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. 6 months from the date of randomization. 2.Proportion of patients eligible for radical RT versus radical CT and RT in each treatment arm. 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. 2. To compare progression free survival and overall survival between two groups
Trial Locations
- Locations (1)
institute rotary cancer hospital,all india institute of medical sciences
🇮🇳South, DELHI, India
institute rotary cancer hospital,all india institute of medical sciences🇮🇳South, DELHI, IndiaDr Arvind KumarPrincipal investigator9871584654hidrarvind@gmail.com