A study on carcinoma of oral cavity undergoing surgery and then treated with radiation therapy with lesser number of treatment fractions
- Conditions
- Health Condition 1: C060- Malignant neoplasm of cheek mucosaHealth Condition 2: C049- Malignant neoplasm of floor of mouth, unspecifiedHealth Condition 3: C039- Malignant neoplasm of gum, unspecifiedHealth Condition 4: C029- Malignant neoplasm of tongue, unspecified
- Registration Number
- CTRI/2023/02/049519
- Lead Sponsor
- Dr RMLIMS Lucknow
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Post-operative patients (age 18-80 years) of oral cavity squamous cell carcinoma (excluding lip).
2. Karnofsky performance status 70 or above
3. One or more of the following risk factors: pT3/pT4, Node positive, Close margin (1-5mm), Perineural invasion present, Lympho-vascular invasion present, depth of invasion >= 4mm for tongue and >=7 mm for buccal mucosa
4. Patients with indications for chemo-radiation but who are
5. unfit for chemotherapy due to associated comorbid conditions or poor GC
6. unwilling to undergo chemotherapy
1. Patients with absolute indications for concurrent chemo-radiotherapy (margin positive disease, extra-capsular extension)
2. Patients who have received neoadjuvant chemotherapy.
3. Any histopathology other than SCC
4. Previous radiotherapy to the head and neck region
5. Patients with absolute indications for concurrent chemoradiotherapy.
6. Synchronous or metachronous malignancy
7. Pregnant or lactating women
8. Uncontrolled concurrent illness like DM, HTN
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the acute toxicity in the patients of post-operative oral cavity Squamous Cell Carcinoma (OCSCC) treated with Hypo-fractionated intensity modulated radiotherapy. <br/ ><br> <br/ ><br>Timepoint: During radiotherapy, acute toxicity will be assessed at every week (Week 1- Week 5), then every 2 weekly for 2 months and then at 3 months after completion of radiotherapy <br/ ><br>
- Secondary Outcome Measures
Name Time Method To evaluate the efficacy in terms of loco-regional control (LRC) and late toxicity in the patients of post-operative oral cavity Squamous Cell Carcinoma (OCSCC) treated with Hypo-fractionated intensity modulated radiotherapy. <br/ ><br>Timepoint: Late toxicity will be evaluated starting from 3 months after completion of radiotherapy and will be assessed at 3 months, 6 months, 12 months, 18 months and 24 months from the date of completion of radiotherapy <br/ ><br>Loco-regional control will be assessed at 18 months and 24 months after completion of radiotherapy