Impact of NACT on surgical decision and peri-operative outcome in patients with very advanced buccal cancer
- Conditions
- Health Condition 1: 4- Measurement and Monitoring
- Registration Number
- CTRI/2024/06/069588
- Lead Sponsor
- AIIMS, New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
. All patients age 18 years and above with the confirmed diagnosis of locally advanced non metastatic carcinoma- buccal mucosa who were deemed as borderline resectable on multi-disciplinary team discussion and received neo-adjuvant chemotherapy before definitive surgery from January 1 , 2019 to Feb 2023 at both the centres( retrospective study) .
2. For prospective part of study, all newly diagnosed locally advanced- non metastatic carcinoma buccal mucosa patients who will be fulfilling below mentioned criteria for borderline resectability will be included.
a. Gingivo- buccal complex cancers with extensive skin involvement.
b. Skin edema reaching upto the level of zygoma.
c. Lateral pterygoid muscle, temporalis insertion or retroantral fat involvement.
3. Performance status: 0-1
4. Medically fit for definitive surgery
All patients with disease extension to infra-notch area and pterygo-maxillary fissure involvement will not be included in the study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Surgical conversion Rate <br/ ><br>3.Clinical and radiological factors associated with operability and chemotherapy effectiveness: <br/ ><br>4.To evaluate surgical margins in patients who received neo-adjuvant chemotherapy before surgery: <br/ ><br>5.Surgical outcomesTimepoint: 3 weeks
- Secondary Outcome Measures
Name Time Method 1.Total Duration of hospital stay after surgery: <br/ ><br>a.For calculation of number of days, day will be calculated from date of surgery to day of discharge. <br/ ><br>2.Radiological assessment of tumor response post neo-adjuvant chemotherapy in prospectively involved patients: <br/ ><br>a.Response will be assessed as per RECIST guidelines <br/ ><br>Timepoint: 3 weeks