Perioperative Gemcitabine based chemotherapy versus upfront resection followed by adjuvant capecitabine with and chemo-radiation in operable Stage III Gall bladder cancers (GBC) – A Randomised, open-label, Two-Arm phase III Prospective Clinical Trial
概览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 294
- 试验地点
- 1
- 主要终点
- To evaluate difference in OS at 36 months between perioperative gemcitabine-cisplatin-
概览
简要总结
Short title : Perioperative Gemcitabine based chemotherapy vs surgery and adjuvant capecitabine with chemoradiation in operable GBC
Indication
Patients with operable gallbladder cancer to find out whether the addition of chemotherapy before the surgery improves the survival.
Type of study
Randomized, open label phase III clinical trial
Study design
Patients with operable Gall Bladder Cancer will undergo randomization into one of two arms
Arm A (Perioperative Arm)
Patients will receive perioperative therapy in this arm - Surgery will be sandwiched between chemotherapy before and after surgery in this arm.
Gemcitabine (G) 800mg/m2 plus Nab-paclitaxel (NabP) 100mg/m2 plus Cisplatin (C) 25mg/m2 (GCNabP)
D1, D8, q 21 days
1 cycle = 21 days
Patient will receive 2-4 cycles of GCNabP followed by assessment for surgery. Post-surgery, patient will receive 2-4 cycles of GC. Patient will be planned for a total of 6 to 8 cycles of chemotherapy perioperatively.
Arm B –(Surgery followed by Capecitabine and capecitabine radiation concurrently)
Patient will undergo upfront surgery in this arm, followed by adjuvant oral chemotherapy.
Surgery→
Capecitabine 6 #
And capecitabine plus radiation
Sample size
294 patients
Study duration
7 years
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 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Histologically confirmed adenocarcinoma (FNAC or biopsy) of the gallbladder 2.No radiological or clinical evidence of metastatic disease and no evidence of metastatic disease as discovered by on-table evaluation during definitive surgery 3.Patients presenting with pT3 or/and pN + disease after simple cholecystectomies who are non-metastatic and still resectable 4.The patients who present with upfront cT3 and or cN+ disease and are non-metastatic and resectable 5.The patients who present with upfront cT2 and cN+ disease and are non-metastatic and resectable 6.Operable disease decided in MDT 7.ECOG performance status
- •1 8.Patient does not have any contraindications to receive chemotherapy 9.Adequate hematological, hepatic and renal function parameters.
- •hematological- Hb greater than 80 g/L, ANC greater than or equal to 1.5 x 109/L, platelets greater than or equal to 100 x 109/L. Liver functions- bilirubin lesser than or equal to 2 x upper limit normal (ULN), AST/ALT lesser than or equal to 5 x ULN, S. albumin greater than or equal to 2.8 g/L 10.Renal function- Creatinine lesser than or equal to 1.5 ULN, Creatinine clearance greater than or equal to 50 mL/min. 11.Women of childbearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial.
排除标准
- •1.Known hypersensitivity or contraindications against gemcitabine, cisplatin, Nab-Paclitaxel or CAPECITABINE or radiation therapy.
- •2.Radiological T1 patients will not be included if radiologists are sure about the cT1 at presentation 3.Clinically significant active coronary heart disease, cardiomyopathy, valvular heart disease or congestive heart failure, NYHA III-IV, 4.Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix 5.Other severe internal disease or acute infection 6.Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
结局指标
主要结局
To evaluate difference in OS at 36 months between perioperative gemcitabine-cisplatin-
时间窗: To evaluate difference in OS at 36 months between perioperative gemcitabine-cisplatin- | nabPaclitaxel (sequence of neoadjuvant Gemcitabine-Cisplatin - nabPAclitaxel followed by | surgery and adjuvant gemcitabine-cisplatin) and upfront surgery and adjuvant oral | CAPECITABINEand concurrent cape-RT for in operable Gall BladderCancers. | Assessments will be done at baseline and after every 4 cycles
nabPaclitaxel (sequence of neoadjuvant Gemcitabine-Cisplatin - nabPAclitaxel followed by
时间窗: To evaluate difference in OS at 36 months between perioperative gemcitabine-cisplatin- | nabPaclitaxel (sequence of neoadjuvant Gemcitabine-Cisplatin - nabPAclitaxel followed by | surgery and adjuvant gemcitabine-cisplatin) and upfront surgery and adjuvant oral | CAPECITABINEand concurrent cape-RT for in operable Gall BladderCancers. | Assessments will be done at baseline and after every 4 cycles
surgery and adjuvant gemcitabine-cisplatin) and upfront surgery and adjuvant oral
时间窗: To evaluate difference in OS at 36 months between perioperative gemcitabine-cisplatin- | nabPaclitaxel (sequence of neoadjuvant Gemcitabine-Cisplatin - nabPAclitaxel followed by | surgery and adjuvant gemcitabine-cisplatin) and upfront surgery and adjuvant oral | CAPECITABINEand concurrent cape-RT for in operable Gall BladderCancers. | Assessments will be done at baseline and after every 4 cycles
CAPECITABINEand concurrent cape-RT for in operable Gall BladderCancers.
时间窗: To evaluate difference in OS at 36 months between perioperative gemcitabine-cisplatin- | nabPaclitaxel (sequence of neoadjuvant Gemcitabine-Cisplatin - nabPAclitaxel followed by | surgery and adjuvant gemcitabine-cisplatin) and upfront surgery and adjuvant oral | CAPECITABINEand concurrent cape-RT for in operable Gall BladderCancers. | Assessments will be done at baseline and after every 4 cycles
次要结局
- To evaluate difference in DFS at 36 months between perioperative gemcitabine-cisplatin-(nabPaclitaxel (sequence of neoadjuvant Gemcitabine-Cisplatin - nabPAclitaxel followed)
研究者
Dr Vikas Ostwal
Tata Memorial Hospital