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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
Recruiting
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
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 –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
NameTimeMethod
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
NameTimeMethod
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, India
Dr Arvind Kumar
Principal investigator
9871584654
hidrarvind@gmail.com

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