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Preoperative Systemic Therapy for Colorectal Cancer Peritoneal Metastases

Primary Purpose

Colorectal Neoplasms, Colorectal Cancer, Colorectal Cancer Metastatic

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Preoperative systematic therapy
CRS+HIPEC
Postoperative chemotherapy
Postoperative chemotherapy
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sixth Affiliated Hospital of Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chemotherapy group

Upfront surgery group

Arm Description

6 cycles of mFOLFOXIRI±Bev is followed by cytoreductive surgery. Postoperative 6 cycles of mFOLFOX is scheduled.

Upfront surgery group is followed by 12 cycles of mFOLFOX+Bev

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Response to preoperative systematic therapy
Assessed by tumor regression grade
Major adverse events of systematic therapy
Grade ≥3 adverse events by CTCAE 5.0
Overall survival
From randomization to death of any cause
Intraoperative peritoneal cancer index
Peritoneal cancer index (PCI) is a tool which sum scores in thirteen abdominal regions according to tumor size.
Complete cytoreductive surgery
R0/R1 resection or CC0/CC1 resection
Hospitalization time
Safety of cytoreductive surgery

Full Information

First Posted
April 22, 2022
Last Updated
April 28, 2022
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05353582
Brief Title
Preoperative Systemic Therapy for Colorectal Cancer Peritoneal Metastases
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Colorectal Cancer, Colorectal Cancer Metastatic, Peritoneal Metastases, Peritoneal Cancer, Peritoneal Neoplasms, Chemotherapy Effect, Cytoreductive Surgery, Hyperthermic Intraperitoneal Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy group
Arm Type
Experimental
Arm Description
6 cycles of mFOLFOXIRI±Bev is followed by cytoreductive surgery. Postoperative 6 cycles of mFOLFOX is scheduled.
Arm Title
Upfront surgery group
Arm Type
Active Comparator
Arm Description
Upfront surgery group is followed by 12 cycles of mFOLFOX+Bev
Intervention Type
Drug
Intervention Name(s)
Preoperative systematic therapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
CRS+HIPEC
Intervention Description
CRS+HIPEC aims to achieve CC0/CC1 resection. Oxaliplatin or mitomycin C is determined by the treating physician.
Intervention Type
Drug
Intervention Name(s)
Postoperative chemotherapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Postoperative chemotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression free survival
Description
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
Secondary Outcome Measure Information:
Title
Response to preoperative systematic therapy
Description
Assessed by tumor regression grade
Time Frame
About 4 months after randomization
Title
Major adverse events of systematic therapy
Description
Grade ≥3 adverse events by CTCAE 5.0
Time Frame
Up to 8 months after randomization
Title
Overall survival
Description
From randomization to death of any cause
Time Frame
Up to five years after randomization
Title
Intraoperative peritoneal cancer index
Description
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
Title
Complete cytoreductive surgery
Description
R0/R1 resection or CC0/CC1 resection
Time Frame
About 4 months after randomization
Title
Hospitalization time
Description
Safety of cytoreductive surgery
Time Frame
About 4 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Wang, MD
Phone
+86-13926424886
Email
wang89@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Huaiming Wang
Email
wanghm@mail.ssysu.edu.cn
Facility Information:
Facility Name
Sixth Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Wang

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Participant-level raw data will not publically available unless reasonable request.

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Preoperative Systemic Therapy for Colorectal Cancer Peritoneal Metastases

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