Status: New
| Name & address of the Laboratory/Organization | Tata Memorial Centre | |
| Website address | https://tmc.gov.in | |
| Affiliated to which Department/Ministry | Department Of Atomic Energy (DAE) | |
| CSR Registration Number | CSR00001287 | |
| Registration under 12A | 12A Registration no. - INS/12128 Provisional approval no.- AAATT3620RE20214 | |
| Registration under 80G | DIT(E)/ITO(Tech)/80G/2010-11 Provisional approval no.- AAATT3620RF20241 | |
| Name of the CSR Nodal | Dr. Heena Shaikh | |
| Contact information of CSR Nodal | +91-22 -68735000 Extn: 5483, hshaikh@actrec.gov.in | |
| Principal Investigator | Dr.Vikas Ostwal, hshaikh@actrec.gov.in | |
| Co- Principal Investigator (Co-PI) | ||
| Objective on the basis of need | We are conducting this study to evaluate the possible benefit of three-drug chemotherapy before the surgery in comparison to direct surgery and then chemotherapy (a current standard) in operable Gall Bladder Cancers. This is to reduce recurrences and deaths of these cancers in spite of surgery and chemotherapy. The primary objective of this study is to assess whether placing three drugs chemotherapy before the surgery can improve and prolong life more as compared to the current standard of surgery and chemotherapy with one or two drugs in operable Gall Bladder Cancers |
| Executive summary of the proposed project (In 250 words) | The primary modality of treatment for operable Gall Bladder Cancers is surgery and one or two drugs chemotherapy. However, a significant proportion of patients with Stage II (50%-60%) and Stage III (70%-90%) cancers develop reoccurrence and death leading to shorter life spans despite these treatments. When we give chemotherapy, especially with three drug options to these patients, they have a possible chance of benefitting by reducing the tumor size and killing the circulating microscopic cells. We are benching on translating these benefits to improve the life span and cure rates. In this study, we will include patients with operable gallbladder cancer to find out whether the addition of chemotherapy before the surgery improves survival. This is a randomized, phase III clinical trial. A total of 294 patients will be enrolled in the study. Arm A (Perioperative Arm) in which the surgery will be sandwiched between chemotherapy. Gemcitabine (G) 800mg/m2 plus Nab-paclitaxel (NabP) 100mg/m2 plus Cisplatin (C) 25mg/m2 (GCNabP) on day 1 and day 8 every 21 days which makes 1 cycle. Patient will receive 2-4 cycles of GCNabP followed by assessment for surgery. 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). The patient will undergo upfront surgery in this arm, followed by adjuvant oral chemotherapy plus radiation The complete evaluation of results and compilation of statistics will be performed approximately 24 months after the last patient has been entered into trial and all follow-up formalities are completed. |
| Technology Readiness Level (If not a new project but an advancement of existing know how) | The lack of initial adequate randomized phase III data suggesting a definitive benefit to adjuvant therapy has hampered the uptake of this modality in Gall bladder cancers (GBC) till recently. However, now we have three randomized trials and many other studies showing a controversial benefit of one of two drug chemotherapy after surgery, and these studies showed not much increment in the cure rates! This brings the novelty in this study of placing the chemotherapy (not only 1/ 2 but 3 drug chemotherapy) before the curative surgery to kill the micrometastasis / circulating microscopic cells and reduce the tumor size, making surgery easy and smaller and avoiding intraoperative surgery failure. |
| Outomes or Deliverables | Through this study, we expect 15% more patients surviving longer with pre-surgery three-drug chemotherapy compared to surgery followed by chemotherapy. |
| Project aligned with which most relevant UN SDGs | Goal 3 - Good Health & Well-Being |
| Duration (In years) | 7 years |
| Expected Impact | We expect 15% improvements in survival at 3 years with perioperative injectable chemotherapy. This will be helpful for patients with operable gallbladder cancers in India. |
| Implementation model (self- implemented/ outsourced partnership) | Tata Memorial Hospital will be primary coordinating center for the study. After availability of funding, the study will be initiated. The patients will be recruited over the period of 5 years. The patients will be followed up by study team for toxicity assessment during and after study period. |
| Total Budget (Recurring +Non-Recurring Expenses) | Rs 1,01,87,180/- |