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| ID | Type | Description | Link |
|---|---|---|---|
| RES/SCM/61/2023/89 | Other Identifier | RAJIV GANDHI CANCER INSTITUTE AND REASEARCH CENTRE,INDIA |
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to study role of chemotherapy treatment for gall bladder cancer before surgery as compared to surgery directly
Gallbladder cancer is a highly aggressive disease with a late presentation and poor prognosis. Complete surgical excision remains the only potentially curative treatment for early-stage gallbladder cancer.
The use and benefit of chemotherapy in gallbladder cancer before surgery , that is , in the neoadjuvant setting, is not well studied and, to our knowledge, neoadjuvant chemotherapy has not been evaluated in any randomized clinical trial.
Neoadjuvant chemotherapy aims to achieve tumor downstaging, increase the radical surgical resection rate, reduce metastases. This study will compare the effectiveness of chemotherapy before surgery in locally advanced gall bladder cancer versus upfront surgery with respect to survival and completeness of resection of disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| upfront surgery | Experimental | after staging workup and biopsy, patient being taken up for upfront surgical exploration will undergo staging laparoscopy followed by exploration and interaortocaval lymphnode sampling. After ruling out distant metastasis, local resectability will be reassessed and curative surgery will be performed. . Post-operative complications were recorded and graded according Clavien Dindo classification |
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| Neoadjuvant chemotherapy followed by surgery | Experimental | NACT group will receive gemcitabine and platinum combination. Most common regimen comprised of gemcitabine (1000 mg/ m2 intravenously over 30-60 min) on days 1 and 8, and cisplatin (75 mg/ m2 intravenously over 2 h) on day 1, every 21 days. In case of renal compromise, carboplatin was used. Response was assessed using CECT abdomen and PET scan. Chemotherapy related toxicity will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v 5 .0. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neoadjuvant chemotherapy | Drug | NACT group will receive gemcitabine and platinum combination. Most common regimen comprised of gemcitabine (1000 mg/ m2 intravenously over 30-60 min) on days 1 and 8, and cisplatin (75 mg/ m2 intravenously over 2 h) on day 1, every 21 days. In case of renal compromise, carboplatin was used. Response was assessed using CECT abdomen and PET scan. Chemotherapy related toxicity will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v 5 .0. PAtients will undergo curative surgery after neoadjuvant chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| improvement in 3 year overall survival | To compare the 3 year overall survival with Neoadjuvant chemotherapy and surgery versus upfront surgery in locally advanced resectable gall bladder cancer | 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| post operative outcomes | To compare mortality and morbidity rate in two groups | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shivendra Singh, Mch | Contact | +919818975024 | shiven_24@yahoo.co.in | |
| Shaifali Goel, DrNB | Contact | +918368382060 | doctor.shaifali@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Shivendra Singh, Mch Surgical gastroenterology | Rajiv Gandhi Cancer Institute and Research Centre | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rajiv Gandhi Cancer Institute and Research Centre | Recruiting | Delhi | National Capital Territory of Delhi | 110085 | India |
Institutional Policy
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| ID | Term |
|---|---|
| D005706 | Gallbladder Neoplasms |
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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| curative surgery | Procedure | Patient being taken up for surgical exploration will undergo staging laparoscopy followed by exploration and interaortocaval lymphnode sampling. After ruling out distant metastasis, local resectability will be reassessed and curative surgery will be performed. . Post-operative complications were recorded and graded according Clavien Dindo classification |
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| Rajiv Gandhi Cancer Institute and Research Centre | Recruiting | Delhi | National Capital Territory of Delhi | 110085 | India |
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| Rajiv Gandhi Cancer Institute and Research Centre | Recruiting | Delhi | National Capital Territory of Delhi | 110085 | India |
| D001660 |
| Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D005705 | Gallbladder Diseases |