Genetic, immune and treatment-related differences in cancers of the mouth and throat in India.
Phase 2
- Conditions
- Health Condition 1: C32- Malignant neoplasm of larynxHealth Condition 2: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Registration Number
- CTRI/2020/10/028482
- Lead Sponsor
- ational Institutes of Health USA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1) Squamous Cancer of oropharynx, larynx or hypopharynx
2) Stage III-IV;
3) Planned for curative intent treatment with radiation & concomitant platinum based chemotherapy;
4) Creatinine clearance (more than or equal to 50 mL/min prior to starting chemotherapy)
5) WHO performance status 0 or 1
Exclusion Criteria
1) Documented evidence of pre-existing swallowing dysfunction (not related to HNC);
2) Previous radiotherapy to the head and neck region;
3) Major head and neck surgery (excluding biopsies/tonsillectomy);
4) Tracheostomy placement before the start of chemoradiation;
5) Previous or concurrent illness, which in the investigatorâ??s opinion would interfere with completion of therapy, trial assessments or follow-up.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Symptomatic aspiration pneumonia (i.e., clinical or radiological evidence of pneumonia; and symptoms of aspiration â?? e.g. cough on swallow or documented silent aspiration on clinical swallowing tests/FEES); <br/ ><br>2) Death due to any cause during or within 3 months of completion of radical intent chemoradiation.Timepoint: Three months of completion of Radiotherapy and concomitant chemotherapy
- Secondary Outcome Measures
Name Time Method 1) Weight loss <br/ ><br>2) Enteral feeding tube dependenceTimepoint: At completion of treatment and at 3 months of treatment completion.