Colorectal NeoplasmsPhase 2NCT05353582
Preoperative Systemic Therapy for Colorectal Cancer Peritoneal Metastases
A Phase 2 study testing Preoperative systematic therapy, CRS+HIPEC and Postoperative chemotherapy in people with Colorectal Neoplasms and Colorectal Cancer, run by Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Neoplasms, Colorectal Cancer, Colorectal Cancer Metastatic
- What is being tested?
- Preoperative systematic therapy, CRS+HIPEC and Postoperative chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 1 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Huaiming Wang contact
China1 site
Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
Hui Wang
About this study
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
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.
- Conditions
- Colorectal Neoplasms, Colorectal Cancer, Colorectal Cancer Metastatic, Peritoneal Metastases, Peritoneal Cancer, Peritoneal Neoplasms
- Being tested
- Preoperative systematic therapy, CRS+HIPEC, Postoperative chemotherapy
- Medical subject headings
- Colorectal Neoplasms, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative systematic therapyDrug
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+HIPECProcedure or surgery
CRS+HIPEC aims to achieve CC0/CC1 resection. Oxaliplatin or mitomycin C is determined by the treating physician.
Postoperative chemotherapyDrug
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 chemotherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy group | Experimental | 6 cycles of mFOLFOXIRI±Bev is followed by cytoreductive surgery. Postoperative 6 cycles of mFOLFOX is scheduled. Receives: Drug: Preoperative systematic therapy; Procedure: CRS+HIPEC; Drug: Postoperative chemotherapy |
| Upfront surgery group | Active comparator | Upfront surgery group is followed by 12 cycles of mFOLFOX+Bev Receives: Procedure: CRS+HIPEC; Drug: Postoperative chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to five years after randomization
Secondary outcomes (6)
Response to preoperative systematic therapy
Assessed by tumor regression grade
Measured: About 4 months after randomization
Major adverse events of systematic therapy
Grade ≥3 adverse events by CTCAE 5.0
Measured: Up to 8 months after randomization
Overall survival
From randomization to death of any cause
Measured: 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.
Measured: About 4 months after randomization
Complete cytoreductive surgery
R0/R1 resection or CC0/CC1 resection
Measured: About 4 months after randomization
Hospitalization time
Safety of cytoreductive surgery
Measured: About 4 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Deng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353582
- Sponsor's protocol ID
- STUCS
- Status last verified
- Apr 2022
- First submitted
- 22 Apr 2022
- Last updated
- 29 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant-level raw data will not publically available unless reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05353582
- Acronym / sponsor ID
- STUCS
- Conditions
- Colorectal Neoplasms, Colorectal Cancer, Colorectal Cancer Metastatic, Peritoneal Metastases, Peritoneal Cancer, Peritoneal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy group | Experimental | Drug: Preoperative systematic therapy, Procedure: CRS+HIPEC, Drug: Postoperative chemotherapy6 cycles of mFOLFOXIRI±Bev is followed by cytoreductive surgery. Postoperative 6 cycles of mFOLFOX is scheduled. |
| Upfront surgery group | Active comparator | Procedure: CRS+HIPEC, Drug: Postoperative chemotherapyUpfront surgery group is followed by 12 cycles of mFOLFOX+Bev |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative systematic therapy6 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. | Drug | Chemotherapy group |
| CRS+HIPECCRS+HIPEC aims to achieve CC0/CC1 resection. Oxaliplatin or mitomycin C is determined by the treating physician. | Procedure or surgery | Chemotherapy group, Upfront surgery group |
| Postoperative chemotherapy6 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. | Drug | Chemotherapy group |
| Postoperative chemotherapy12 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. | Drug | Upfront surgery group |
Primary outcome
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.
6 secondary outcomes
Response to preoperative systematic therapy
Time frame: About 4 months after randomization
Major adverse events of systematic therapy
Time frame: Up to 8 months after randomization
Overall survival
Time frame: Up to five years after randomization
Intraoperative peritoneal cancer index
Time frame: About 4 months after randomization
Complete cytoreductive surgery
Time frame: About 4 months after randomization
Hospitalization time
Time frame: About 4 months after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: No. Participant-level raw data will not publically available unless reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huaiming Wang contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Preoperative systematic therapy, CRS+HIPEC and Postoperative chemotherapy in people with Colorectal Neoplasms and Colorectal Cancer, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Wang, MD (+86-13926424886, wang89@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: Up to five years after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.