Preoperative Systemic Therapy for Colorectal Cancer Peritoneal Metastases

Colorectal Cancer Clinical Trial

Official title:

Preoperative Systemic Therapy With FOLFOXIRI Plus Bevacizumab Followed by Cytoreductive Surgery Versus Upfront Cytoreductive Surgery for Resectable Colorectal Peritoneal Metastases: A Randomized Phase 2 Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05353582
• Other study ID #: STUCS
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2022
• Est. completion date: July 1, 2025

Study information

• Verified date: April 2022
• Source: Sun Yat-sen University
• Contact: Hui Wang, MD
• Phone: +86-13926424886
• Email: wang89[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 168
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Historically and radiologically confirmed colorectal cancer peritoneal metastasis except for appendical origin;
• Tolerable to scheduled chemotherapy;
• No evidence of extraperitoneal metastases at enrollment;
• Resectable disease determined by radiological and laparoscopy/laparotomy;
• No systematic therapy within 6 months before enrollment;
• Tolerable to cytoreductive surgery.

Exclusion Criteria:

• Without adequate organ function (e.g. :neutrophil countt=1.5×10^9/L, or platelets=75×10^12/L,or hemoglobin<90g/L, or aminotransferase?aspartate aminotransferaseAST<2.5ULN, or total bilirubin<1.5ULN, or creatinine<1.5ULN;
• Emergency surgery;
• Recent thromboembolic event or cerebrovascular disease (12 months before enrollment);
• Pregnancy or lactation
• Comorbid with severe physical or mental disease.

Related Conditions & MeSH terms

• Chemotherapy Effect
• Colorectal Cancer
• Colorectal Cancer Metastatic
• Colorectal Neoplasms
• Cytoreductive Surgery
• Hyperthermic Intraperitoneal Chemotherapy
• Neoplasm Metastasis
• Neoplasms
• Peritoneal Cancer
• Peritoneal Metastases
• Peritoneal Neoplasms

Intervention

Drug:
• Preoperative systematic therapy
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.

Procedure:
• CRS+HIPEC
CRS+HIPEC aims to achieve CC0/CC1 resection. Oxaliplatin or mitomycin C is determined by the treating physician.

Drug:
• Postoperative chemotherapy
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
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.

Locations

Country	Name	City	State
China	Sixth Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Response to preoperative systematic therapy	Assessed by tumor regression grade	About 4 months after randomization
Secondary	Major adverse events of systematic therapy	Grade =3 adverse events by CTCAE 5.0	Up to 8 months after randomization
Secondary	Overall survival	From randomization to death of any cause	Up to five years after randomization
Secondary	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
Secondary	Complete cytoreductive surgery	R0/R1 resection or CC0/CC1 resection	About 4 months after randomization
Secondary	Hospitalization time	Safety of cytoreductive surgery	About 4 months after randomization