A Phase 2 Open label Randomised Controlled Trial Comparing Modified TPF with Docetaxel-Platinum Regimen as Neoadjuvant Chemotherapy in Locally Advanced Resectable Oral Cavity Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- To compare between the two study arms the overall response rates after neoadjuvant chemotherapy
研究概览
简要总结
The study intends to find a regimen which will be more efficacious yet tolerable in comparison to a platinum-taxol based two drug regimen. This new regimen, if found to be superior may replace the standard 3 weekly TPF regimen in different settings. It has been shown in multiple studies that three drug regimen (standard TPF) although efficacious is associated with significant incidence of adverse events thus, limiting its use in clinics. Besides, a 5 day infusion protocol is another deterrent due to logistic issues of limited indoor beds in hospitals.
The selection of patient population of resectable oral cavity cancers is based on the newly generated interest on less demolitive surgery post NACT, including mandibular preservation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Histologically confirmed squamous cell carcinoma of the oral cavity Patients with a resectable lesion, with clinical stage III or IVA disease (T3N0 or T1-3N1-2M0 or T4aN0-2M0 according to Union for International Cancer Control [2018]).
- •ECOG PS 0-1 Meeting the following standard values of general laboratory tests completed within 7 days prior to randomization and values are within the parameters required by the protocol: a) WBC count more than 4,000/μL, hemoglobin more than 8 g/L, platelet count more than 100,000/μL b) ALT and AST less than 2.5× the upper limit of normal c) Total bilirubin less than 1.5× the upper limit of normal d) Serum creatinine less than 1.5× the upper limit of normal Written informed consent.
排除标准
- •Distant metastasis or other cancers Have undergone surgery involving primary tumor or lymph nodes (except diagnostic biopsy) Have received any prior radiotherapy or chemotherapy Have had other malignancies within 5 years Have creatinine clearance less than 60 mL/min.
- •Cisplatin ineligible patients Unstable angina within 3 weeks, or with a history of myocardial infarction within last 6 months Pregnant or breastfeeding females or those not willing for contraception.
结局指标
主要结局
To compare between the two study arms the overall response rates after neoadjuvant chemotherapy
时间窗: 12-14 weeks
次要结局
- Evaluate the rate of pathologic complete response (pCR) in both arms (primary tumor & node)(16 weeks)
- Evaluate major pathological response in primary tumor in both arms(16 weeks)
- Compare the accuracy of contrast-enhanced CT vs 18FDG-PET-CT in predicting complete pathological & major pathological response post NACT in both arms
- Evaluate the incidence & severity of adverse events according to the CTCAE v5.0 criteria in both arms(2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks in Arm B)
- Assess patient-reported outcomes using the EORTC H&N 43 & EORTC QLQ-C30 questionnaire in both study groups.(0 weeks, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks in Arm B)
- Assessment of tumor shrinkage pattern & margin sterility, pre & post NACT(16 weeks)
- To study genetic signatures of tumors with favourable as well as unfavourable pathological response(20 weeks)
研究者
Dr Akash Kumar
AIIMS, New Delhi