Phase II Open Label Study to Investigate Impact of Adaptive Radiotherapy on Quality of Life Score in Patients with Locally Advanced Head and Neck Cancers
Phase 2
Completed
- Conditions
- Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Registration Number
- CTRI/2021/09/036821
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 34
Inclusion Criteria
1. Patients with histologically proven Squamous Cell Carcinoma of head and neck region
2. Age <70 years
3. Primary tumour sites in oral cavity, oropharynx, hypopharynx and larynx.
4.Stage III-IVB by AJCC Cancer Staging Manual Eight Edition, 2018
5.Eastern Cooperative Oncology Group (ECOG) performance status <=2
6.All patients fit for chemo-radiation/Radiation Therapy
Exclusion Criteria
1. Patients with resection of the primary tumour or recurrent disease
2. Patients with distant metastasis
3. Patients who have received prior NACT or surgery
4. Patients who have received prior radiation therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the quality of life in Locally advanced Head and Neck cancer patients undergoing IMRT/Chemo-IMRT with mid treatment adaptive replanningTimepoint: 6 months
- Secondary Outcome Measures
Name Time Method 1. To asses acute toxicity during 6 weeks in patients of Locally advanced Head and Neck cancers undergoing IMRT with mid treatment adaptive replanning <br/ ><br>2. To assess the incidence of xerostomia at 6 months in patients of Locally advanced Head and Neck cancers undergoing IMRT with mid treatment adaptive replanning <br/ ><br>Timepoint: 6 months