Impact of Neo adjuvant chemotherapy on surgical decision and peri-operative outcome in patients with very advanced buccal cancers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. Surgical conversion Rate
研究概览
简要总结
Title: Impact of NACT on surgical decision and perioperative outcome in patient with very advance buccal cancer
Objective:
primary:
1. Surgical conversion Rate:
2. Data will be analysed to see how many patients who received neo-adjuvant chemotherapy as a primary treatment undergo surgery. Clinical and radiological data will also be recorded to identify the factors associated with non-operability decisions. All patients with involvement of masticator space will also be stratified as per classification system given by Mahajan et al. and data will be recorded to see which category of patients undergoing surgery.
3. Clinical and radiological factors associated with operability and chemotherapy effectiveness:
a. Patients undergoing surgery after neo-adjuvant will be identified and clinical and radiological data will be recorded to see which subset of populations respond better to chemotherapy. Data will also be recorded regarding chemotherapy regimen used. Clinical and radiological factors which will be recorded includes: skin involvement, infratemporal fossa involvement, soft tissue swelling upto zygoma.
4. To evaluate surgical margins in patients who received neo-adjuvant chemotherapy before surgery:
a. Data regarding surgical margins will be assessed from the pathological reports. Surgical margins will be classified as free, close and involved.
5. Surgical outcomes:
a. Surgical outcomes will be recorded as per classification system given by Clavein and Dindo
secondary:
1. Total Duration of hospital stay after surgery:
a. For calculation of number of days, day will be calculated from date of surgery to day of discharge.
2. Radiological assessment of tumor response post neo-adjuvant chemotherapy in prospectively involved patients:
Response will be assessed as per RECIST guidelines
To achieve my objectives:
-
Patients post NACT radiological imaging ill will compared with pre-NACT imaging.
-
Response will be assesed
-
Any complication occured will be assessed
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •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) .
- •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.
- •Gingivo- buccal complex cancers with extensive skin involvement.
- •Skin edema reaching upto the level of zygoma.
- •Lateral pterygoid muscle, temporalis insertion or retroantral fat involvement.
- •Performance status: 0-1
- •Medically fit for definitive surgery.
排除标准
- •All patients with disease extension to infra-notch area and pterygo-maxillary fissure involvement will not be included in the study.
结局指标
主要结局
1. Surgical conversion Rate
时间窗: 3 weeks
3. Clinical and radiological factors associated with operability and chemotherapy effectiveness:
时间窗: 3 weeks
4. To evaluate surgical margins in patients who received neo-adjuvant chemotherapy before surgery:
时间窗: 3 weeks
5. Surgical outcomes
时间窗: 3 weeks
次要结局
- 1. Total Duration of hospital stay after surgery:(a. For calculation of number of days, day will be calculated from date of surgery to day of discharge.)
研究者
Akash Mishra
All India Institute of Medical Sciences