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This is an open-label, parallel-group, phase 2 randomized trial which randomizes patients with isolated resectable colorectal cancer peritoneal metastases to receive preoperative systematic therapy followed by CRS+HIPEC and postoperative chemotherapy or upfront CRS+HIPEC followed by postoperative chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy group | Experimental | 6 cycles of mFOLFOXIRI±Bev is followed by cytoreductive surgery. Postoperative 6 cycles of mFOLFOX is scheduled. |
|
| Upfront surgery group | Active Comparator | Upfront surgery group is followed by 12 cycles of mFOLFOX+Bev |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative systematic therapy | Drug | 6 cycles of mFOLFOXIRI±Bev is administrated before CRS+HIPEC. Irinotecan165mg/m2 IV day 1, oxaliplatin 85mg/m2 IV day 1, leucovorin 400mg/m2 IV day , bevacizumab mg/kg IV day 1, 5-fluorouracil 400mg/m2, continuous infusion over 46-48h. Dose reduction is permitted. Bev will not be administrated in at the last two cycles for minimizing surgery complications. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | From randomization to progression by RECIST1.1, or appearance of measurable lesion after non-measureable lesion, or intraoperative unresectable disease, or recurrence after surgery, or death from any reason. | Up to five years after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Response to preoperative systematic therapy | Assessed by tumor regression grade | About 4 months after randomization |
| Major adverse events of systematic therapy | Grade ≥3 adverse events by CTCAE 5.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Wang, MD | Contact | +86-13926424886 | wang89@mail.sysu.edu.cn | |
| Huaiming Wang | Contact | wanghm@mail.ssysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sixth Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510655 | China |
Participant-level raw data will not publically available unless reasonable request.
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|
| CRS+HIPEC | Procedure | CRS+HIPEC aims to achieve CC0/CC1 resection. Oxaliplatin or mitomycin C is determined by the treating physician. |
|
| Postoperative chemotherapy | Drug | 6 cycles of mFOLFOX+Bev is administrated after CRS+HIPEC. Oxaliplatin 85mg/m2 IV day 1, leucovorin 400mg/m2 IV day , bevacizumab mg/kg IV day 1, 5-fluorouracil 400mg/m2 IV bolus day 1,5-fluorouracil 400mg/m2, continuous infusion over 46-48h. Dose reduction is permitted. |
|
| Postoperative chemotherapy | Drug | 12 cycles of mFOLFOX+Bev is administrated after CRS+HIPEC. Oxaliplatin 85mg/m2 IV day 1, leucovorin 400mg/m2 IV day , bevacizumab mg/kg IV day 1, 5-fluorouracil 400mg/m2 IV bolus day 1,5-fluorouracil 400mg/m2, continuous infusion over 46-48h. Dose reduction is permitted. |
|
| Up to 8 months after randomization |
| Overall survival | From randomization to death of any cause | Up to five years after randomization |
| Intraoperative peritoneal cancer index | Peritoneal cancer index (PCI) is a tool which sum scores in thirteen abdominal regions according to tumor size. | About 4 months after randomization |
| Complete cytoreductive surgery | R0/R1 resection or CC0/CC1 resection | About 4 months after randomization |
| Hospitalization time | Safety of cytoreductive surgery | About 4 months after randomization |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D010534 | Peritoneal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D000008 | Abdominal Neoplasms |
| D010532 | Peritoneal Diseases |
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