A Phase 2 interventional study of Preoperative systematic therapy and CRS+HIPEC in Colorectal Neoplasms, Colorectal Cancer and Colorectal Cancer Metastatic, sponsored by Sun Yat-sen University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-04-29.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 168 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
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Exclusion Criteria:
6 cycles of mFOLFOXIRI±Bev is followed by cytoreductive surgery. Postoperative 6 cycles of mFOLFOX is scheduled.
Drug: Preoperative systematic therapy · Procedure: CRS+HIPEC · Drug: Postoperative chemotherapy
Upfront surgery group is followed by 12 cycles of mFOLFOX+Bev
Procedure: CRS+HIPEC · Drug: Postoperative chemotherapy
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.
CRS+HIPEC aims to achieve CC0/CC1 resection. Oxaliplatin or mitomycin C is determined by the treating physician.
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.
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.
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.
Time frame: Up to five years after randomization
Response to preoperative systematic therapy
Assessed by tumor regression grade
Time frame: About 4 months after randomization
Major adverse events of systematic therapy
Grade ≥3 adverse events by CTCAE 5.0
Time frame: Up to 8 months after randomization
Overall survival
From randomization to death of any cause
Time frame: 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.
Time frame: About 4 months after randomization
Complete cytoreductive surgery
R0/R1 resection or CC0/CC1 resection
Time frame: About 4 months after randomization
Hospitalization time
Safety of cytoreductive surgery
Time frame: About 4 months after randomization
Plan to share: No — Participant-level raw data will not publically available unless reasonable request.
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This study is not yet recruiting, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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