Optimum radiation dose for palliation in head and neck Squamous cell carcinoma ââ?¬â?? A phase 3 randomized controlled trial (OpRaH)
Phase 3
- Conditions
- Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
- Registration Number
- CTRI/2020/06/025574
- Lead Sponsor
- AIIMS New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
cT4b disease not amenable to surgery in larynx/ Hypopharynx/ Nasopharynx/ Oropharynx/ Oral cavity
Histologically proven squamous cell carcinoma
Not suitable for curative radiation
Non-metastatic disease
Age > 18 years and < 75 years
ECOG PS < 3
Carotid encasement < 180 degree
Exclusion Criteria
Skin ulceration > 2 cm or fistula present
Carotid encasement > 180 degree
Skull base particularly foramen lacerum involvement
Metastatic disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare Progression free survival between high palliative radiation dose (30 Gy/ 5#/ on alternate days) versus low palliative dose (20 Gy/ 5#/ 5 days)Timepoint: To compare Progression free survival between high palliative radiation dose (30 Gy/ 5#/ on alternate days) versus low palliative dose (20 Gy/ 5#/ 5 days)
- Secondary Outcome Measures
Name Time Method To compare acute toxicity between the two radiation doses <br/ ><br>c) To compare Quality of life between the two arms with QOL ââ?¬â?? HN35 questionnaire <br/ ><br>d) To correlate effect of radiotherapy on immune function on flow cytometry of peripheral blood mononuclear cells and cytokine levels and survivalTimepoint: QOL every months after RT