Gemcitabine-cisplatin-albumin bound paclitaxel (GAP) versus gemcitabine-platinum (GP) in advanced gallbladder cancers (GBC) - a randomized parallel design phase III clinical trial (GAP-GB)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 255
- 试验地点
- 6
- 主要终点
- The primary endpoint of the study is to compare the overall survival (OS) of the GAP regimen to Gemcitabine platinum combination.
研究概览
简要总结
Study Title: Gemcitabine-cisplatin-albumin bound paclitaxel (GAP) versus gemcitabine-platinum (GP) in advanced gallbladder cancers (GBC) - a randomized parallel design phase III clinical trial (GAP-GB)
**Indication:**Advanced/metastatic gallbladder cancer (GBC) fit for first line chemotherapy
Type of study : Randomized parallel design two-arm phase III open label
Total around 350 patients will be screened and 255 eligible patients shall be included in this study over 36 months ’period. Patients will be followed for 12 months.
This study will assess the prolongation oflife with 2 different chemotherapy regimens, which are Gemcitabine – Cisplatin – Nab-Paclitaxel (GAP) (3 drugs) and gemcitabine-platinum (GP) combination (2 drugs). Both the regimes are part of standard chemotherapy options in advanced gallbladder cancers. Either of them can be used to treat advanced gallbladder cancers. The side effect profiles of each regime are different. The aim is to look at the superiority of the 3-drug combination against 2 drug combination regimens in prolonging the life. So, this study will look at two standard treatment options in terms of benefit vs. side effects.
The Investigator or a person designated will collect informed consent from all participants, before which the Investigator or co-investigator must inform each participant of the objectives, benefits, risks, and requirements of the study.
Subjects fulfill all in-/exclusion criteria, having provided written informed consent on the approved informed consent form are eligible for participation in the study. They would then be randomized in 1:1 ratio into either of the two arms viz Arm A or Arm B.
The mentioned drug regimens in both arms will be administered as follows:
Arm A
GAP regimen
Gemcitabine (800 mg/m2 IV on day 1 and day 8) plus
Cisplatin (25 mg/m2 IV on day 1 and day 8) plus
Nab Paclitaxel (100 mg/ m2 IV on day 1 and day 8)
Chemotherapy will be repeated every 21 days and considered as one cycle.
Arm B
GP regimens
In Arm B, the patient will receive one of the 3 following chemotherapy treatments
1.Gemcitabine (1000 mg/m2 IV on day 1 and day 8) plus
Cisplatin (25 mg/m2 IV on day 1 and day 8) plus
Every 3 weeks
2.Gemcitabine (1000 mg/m2 IV on day 1 and day 8) plus
Carboplatin (AUC 5/6 on day 1) plus
Every 3 weeks
3.Gemcitabine (1000 mg/m2 IV on day 1) plus
Oxaliplatin (100 mg/m2 IV on day 1) plus
Every 2 weeks
Quality of life analysis will also be conducted in the study.
For all patients, the cost of standard testing and therapywill be borne by the patient. As both arms are standard of care, the cost of serious adverse events and hospitalization of the patients, will be borne by the patient.
This trial is an investigator-initiated trial and will be conducted as per ICMR guidelines. Medical care will be provided for any complications arising from treatment. There will be no compensation provided in the study.
The complete evaluation of results and compilation of statistics will be performed 6-12 months after the last patient has been entered into trial and all follow-up formalities are completed.
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 95.00 Year(s)（—）
- 性别
- All
入选标准
- •Histologically confirmed adenocarcinoma of the gallbladder with the following specifications
- •Locally advanced unresectable or metastatic on radiology
- •Age more than 18 years
- •ECOG performance status 0-2
- •Patient who can give informed consent for the study.
- •Patient does not have any contraindications to receive chemotherapy
- •Adequate Hematological, hepatic and renal function parameters
- •ECG within acceptable limits
- •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
- •Distal cholangiocarcinoma,intrahepatic or perihilar cholangiocarcinomas
- •Known hypersensitivity or contraindications against gemcitabine, cisplatin, oxaliplatin,albumin bound paclitaxel and carboplatin
- •Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure,NYHA III to IV, clinically significant valvular defect
- •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
- •Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy
- •Other severe internal disease or acute infection
- •Baseline neuropathy more than NCI Grade I
- •Chronic inflammatory bowel disease
- •On treatment participation in another clinical study in the period 30 days prior to inclusion and during the study
- •Subject pregnant or breastfeeding, or planning to become pregnant within 6 months after the end of treatment.
- •Patients who have completed adjuvant Gem or Platinum based chemotherapy within 6 months.
结局指标
主要结局
The primary endpoint of the study is to compare the overall survival (OS) of the GAP regimen to Gemcitabine platinum combination.
时间窗: The study duration is of 48 months. | Total around 350 patients will be screened and 255 eligible patients shall be included in this study over 36 months period.Patients will be followed for 12 months. | Response assessment scans will be performed at baseline and after every 4 cycles. | QOL analysis will be conducted at the following time intervals (approximate) at Baseline | At approximately 3 months and 6 months post starting therapy.
次要结局
- Secondary endpoints The secondary endpoints and objectives include(1. To compare the progression free survival (PFS) of the GAP regimen to Gemcitabine platinum combination.)
研究者
Dr Anant Ramaswamy
Tata Memorial Hospital