A pilot study to evaluate a novel regimen of radiotherapy in post-operative patients of head and neck cancers
- Conditions
- Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Registration Number
- CTRI/2021/07/034608
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients with resected head and neck squamous cell cancers with clinical/pathological stage III or stage IV and/or with indications of adjuvant radiotherapy post-surgery
2.WHO ECOG Performance Score of 2 or less.
3.Patients 18 to 70 years age
4.Haemoglobin > 10gm/dL, TLC > 4000/mm3 and Platelet count > 100,000/mm3.
5.Normal liver, renal lung and cardiac function.
6.No evidence of a second primary elsewhere in the body.
1.Cancers with histology other than squamous cell carcinoma
2.Patients who are medically unfit for surgery or not willing for surgery.
3.Distant metastases (Stage IVC)
4.Patients with history of prior malignancy.
5.Patients having received prior chemotherapy and radiotherapy to the head and neck.
6.Patients having undergone surgery involving primary tumour or lymph nodes (except diagnostic biopsy)
7.Patients with signs of severe ischaemic disease, severe arteriosclerosis, active coronary artery disease, cardiac arrhythmia, congestive cardiac failure, and a history of peripheral neuropathy or cerebral stroke.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of acute radiation-induced toxicities or complicationsTimepoint: Less than 90 days
- Secondary Outcome Measures
Name Time Method Disease free survivalTimepoint: 2 years;Locoregional controlTimepoint: 2 years;Overall survivalTimepoint: 2 years;Quality of lifeTimepoint: Immediately post treatment, and at 2 years