- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05353582
Preoperative Systemic Therapy for Colorectal Cancer Peritoneal Metastases
April 28, 2022 updated by: Yanhong Deng, Sun Yat-sen University
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
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.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
168
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hui Wang, MD
- Phone Number: +86-13926424886
- Email: wang89@mail.sysu.edu.cn
Study Contact Backup
- Name: Huaiming Wang
- Email: wanghm@mail.ssysu.edu.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510655
- Sixth Affiliated Hospital of Sun Yat-sen University
-
Contact:
- Hui Wang
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chemotherapy group
6 cycles of mFOLFOXIRI±Bev is followed by cytoreductive surgery.
Postoperative 6 cycles of mFOLFOX is scheduled.
|
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.
|
Active Comparator: Upfront surgery group
Upfront surgery group is followed by 12 cycles of mFOLFOX+Bev
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival
Time Frame: Up to five years after randomization
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response to preoperative systematic therapy
Time Frame: About 4 months after randomization
|
Assessed by tumor regression grade
|
About 4 months after randomization
|
Major adverse events of systematic therapy
Time Frame: Up to 8 months after randomization
|
Grade ≥3 adverse events by CTCAE 5.0
|
Up to 8 months after randomization
|
Overall survival
Time Frame: Up to five years after randomization
|
From randomization to death of any cause
|
Up to five years after randomization
|
Intraoperative peritoneal cancer index
Time Frame: About 4 months after randomization
|
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
Time Frame: About 4 months after randomization
|
R0/R1 resection or CC0/CC1 resection
|
About 4 months after randomization
|
Hospitalization time
Time Frame: About 4 months after randomization
|
Safety of cytoreductive surgery
|
About 4 months after randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2022
Primary Completion (Anticipated)
July 1, 2025
Study Completion (Anticipated)
July 1, 2025
Study Registration Dates
First Submitted
April 22, 2022
First Submitted That Met QC Criteria
April 28, 2022
First Posted (Actual)
April 29, 2022
Study Record Updates
Last Update Posted (Actual)
April 29, 2022
Last Update Submitted That Met QC Criteria
April 28, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms by Site
- Peritoneal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neoplastic Processes
- Abdominal Neoplasms
- Neoplasms
- Colorectal Neoplasms
- Neoplasm Metastasis
- Peritoneal Neoplasms
Other Study ID Numbers
- STUCS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Participant-level raw data will not publically available unless reasonable request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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