margins after chemotherapy in surgery of oral cancer

Phase 3

• Conditions: Health Condition 1: C069- Malignant neoplasm of mouth, unspecifiedHealth Condition 2: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx

• Registration Number: CTRI/2022/03/040885
• Lead Sponsor: BBCI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

STAGE: T4A, T4b

1.Age: 18 years of age and above

2.Site: oral cavity (8 subsites: mucosal lip, buccal mucosa, lower and upper alveolar ridge,

RMT, floor of mouth, hard palate, anterior2/3 rd of tongue.

3.Operability: border line operable cases

4. Gc: ecog-0/1

5. Comorbidities: controlled HTN, controlled DM, systolic dysfunction less than or equal to

grade2.

6.Prior treatment for cancer: nil

Exclusion Criteria

1.Early stages of oral cancer (STAGE1,2,3)

2. Age less than 18 years

3. Gc-PS: more than or equal to 2

4.PRIOR TREATMENT FOR HEAD AND NECK CANCER IN LESS THAN 5 YEARS

5. Non responders to NACT clinically after 2nd cycle.

6. Comorbidities: uncontrolled HTN, uncontrolled DM, systolic dysfunction more than grade 2

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare pathological margins in patients of oral cancer <br/ ><br>Who under go surgery after NACT <br/ ><br>Timepoint: 1month and 6months

Secondary Outcome Measures

Name	Time	Method
Margin positivity rate T4aVST4b <br/ ><br>â?¢Short term recurrence T4aVST4bTimepoint: 6 MONTHS