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Surgery With HIPEC in Treating Patients With a High Risk of Developing Colorectal Peritoneal Carcinomatosis

Primary Purpose

Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4, Peritoneal Carcinomatosis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMC
Sponsored by
Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4 focused on measuring Peritoneal carcinomatosis, HIPEC, controlled clinical trial, colorectal cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Patients presenting with the following history:

    1. Histologically-proven colorectal adenocarcinoma

    2. Presenting at the time of resection of the primary with one of the following 5 criteria (criteria indicating a high risk of developing PC) :

      • Minimal PC, resected at the same time as the primary
      • Rupture of the primary tumour inside the peritoneal cavity,
      • Intraoperative rupture of the primary tumour during surgery
      • Histologically-proven T4 colorectal adenocarcinoma

  • Who have received standard systemic adjuvant chemotherapy (6 months of systemic chemotherapy) :

    1. Chemotherapy with FOLFOX4, mFOLFOX6, CapeOx or Capecitabine(the current standard treatment; it can be modified in the future in the two groups, if the standard is modified)
    2. Given on an intent-to-treat basis (it can be stopped prematurely for miscellaneous reasons)
  • Patients who do not present any sign of tumour recurrence at the end of these 6 months of chemotherapy

  • Patients with the following general characteristics:

    1. Age between 18 and 75 years
    2. Performance Status (ECOG) 0, 1 or 2, life expectancy > 12 weeks
    3. Adequate renal, and bone marrow function: a. Leukocytes >/= 3,000/microL; b. Absolute neutrophil count >/= 1,500/microL; c. Platelets >/= 100,000/Ul; d. Serum creatinine </= 1.5 mg/dL
    4. Hepatic function: a. AST (SGOT)/ALT (SGPT) </= 5 X institutional (Upper Limit of Normal) ULN
    5. Operable patients
    6. Completion of neoadjuvant systemic chemotherapy
  • Patients will be informed and a signed consent before initiating any procedure specific to the trial

Exclusion Criteria:

  1. Cancers of non colorectal origin
  2. Patients presenting with a detectable recurrent tumour
  3. History of cancer (excepted cutaneous basal cell carcinoma or in situ carcinoma of the uterine cervix) with a recurrence during the 5 previous years
  4. Known HIV, Hepatitis B or Hepatitis C positive
  5. Pregnant women or likely to be pregnant
  6. Persons under guardianship
  7. Subjects deemed unable to comply with study and/or follow-up procedures.
  8. Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity

Sites / Locations

  • Union Hospital Fujian Medical University
  • Liaoning Cancer Hospital
  • Zhongshan Hospital Fudan University
  • The First Affiliated Hospital of College of Medicine Zhejiang University
  • Second Affiliated Hospitalof Zhejiang University School of Medicine
  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
  • Jinhua People's Hospital
  • People's Hospital of Shaoxing
  • Yuyao People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Hipec

Arm Description

surgery alone

Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMC

Outcomes

Primary Outcome Measures

Disease-free survival
DFS

Secondary Outcome Measures

3 year overall survival
3-OS
Peritoneal disease-free survival
PDFS
5 year overall survival
5-OS
morbidity
Toxicity induced by HIPEC using the NCI CTC criteria; one month and six months morbidity. Subgroup analysis: pT4; pts. ≤ 40yrs.
QOL
Duration of operation; return of bowel function; length of hospital stay; return to normal activity; six months and one year QOL, using the SF-36 v1.0; percentage of patients in both arms completing the scheduled postoperative chemotherapy; Subgroup analysis: pT4; pts. ≤ 40yrs.

Full Information

First Posted
June 21, 2014
Last Updated
June 24, 2022
Sponsor
Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT02179489
Brief Title
Surgery With HIPEC in Treating Patients With a High Risk of Developing Colorectal Peritoneal Carcinomatosis
Official Title
Randomized Multicentric Phase III Trial Comparing Simple Surgery to Surgery Plus HIPEC (Hyperthermic Intraperitoneal Chemotherapy) With MMC in Colorectal Patients Who Have a High Risk of Developing Colorectal Peritoneal Carcinomatosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2014 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Multicentric randomised trial. The goal of this clinical research study is to learn if hyperthermic intraperitoneal chemotherapy (HIPEC) will help to decrease the rate of peritoneal carcinomatosis(PC) in patients with high risk of developing PC of colorectal cancer. The safety of this treatment will also be studied.
Detailed Description
Hyperthermic intraperitoneal chemotherapy(HIPEC) is a recently validated option for the treatment of peritoneal carcinomatosis from colorectal or ovarian origin. This therapeutic program demonstrated a significant improvement of overall survival of the disease. It is not yet known whether surgery followed by HIPEC is effective on decreasing the rate of peritoneal carcinomatosis(PC) in patients with high risk of developing PC of colorectal cancer.Patients with a high risk of developing colorectal Peritoneal Carcinomatosis (PC), defined by Colorectal Cancer With a Resected Minimal Synchronous PC or Ovarian Metastases, or identified T4 by intraoperative pathological diagnosis, or Tumour Rupture in the Abdominal Cavity. If patients with a high risk of developing PC identified by preoperative examination, they will be informed and will sign the consent. After complete resection of their tumor, they will be randomised to surveillance alone (control group) or HIPEC (experimental group). All patients will receive the current standard postoperative adjuvant treatment : 6 months of systemic chemotherapy (currently including FOLFOX4, mFOLFOX6, CapeOx or Capecitabine regimen which could be modified if the standard is modified). Then a work-up is done to find recurrence. If the recurrence occurs, the patient will be treated with the best known treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4, Peritoneal Carcinomatosis
Keywords
Peritoneal carcinomatosis, HIPEC, controlled clinical trial, colorectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
271 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
surgery alone
Arm Title
Hipec
Arm Type
Experimental
Arm Description
Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMC
Intervention Type
Procedure
Intervention Name(s)
Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMC
Intervention Description
HIPEC with MMC: Mitomycin C (MMC) (30 mg/m2 of body surface area). Closed technique, as preferred. Duration: 60 minutes. Mean Intra-abdominal Temperature: 43°C.
Primary Outcome Measure Information:
Title
Disease-free survival
Description
DFS
Time Frame
Three years from the date of randomization
Secondary Outcome Measure Information:
Title
3 year overall survival
Description
3-OS
Time Frame
3 years
Title
Peritoneal disease-free survival
Description
PDFS
Time Frame
3 years
Title
5 year overall survival
Description
5-OS
Time Frame
5 years
Title
morbidity
Description
Toxicity induced by HIPEC using the NCI CTC criteria; one month and six months morbidity. Subgroup analysis: pT4; pts. ≤ 40yrs.
Time Frame
Baseline before any treatment,3 months post operation, 1 year post operation
Title
QOL
Description
Duration of operation; return of bowel function; length of hospital stay; return to normal activity; six months and one year QOL, using the SF-36 v1.0; percentage of patients in both arms completing the scheduled postoperative chemotherapy; Subgroup analysis: pT4; pts. ≤ 40yrs.
Time Frame
Baseline before any treatment,3 months post operation, 1 year post operation

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: Patients presenting with the following history: Histologically-proven colorectal adenocarcinoma Presenting at the time of resection of the primary with one of the following 5 criteria (criteria indicating a high risk of developing PC) : Minimal PC, resected at the same time as the primary Rupture of the primary tumour inside the peritoneal cavity, Intraoperative rupture of the primary tumour during surgery Histologically-proven T4 colorectal adenocarcinoma Who have received standard systemic adjuvant chemotherapy (6 months of systemic chemotherapy) : Chemotherapy with FOLFOX4, mFOLFOX6, CapeOx or Capecitabine(the current standard treatment; it can be modified in the future in the two groups, if the standard is modified) Given on an intent-to-treat basis (it can be stopped prematurely for miscellaneous reasons) Patients who do not present any sign of tumour recurrence at the end of these 6 months of chemotherapy Patients with the following general characteristics: Age between 18 and 75 years Performance Status (ECOG) 0, 1 or 2, life expectancy > 12 weeks Adequate renal, and bone marrow function: a. Leukocytes >/= 3,000/microL; b. Absolute neutrophil count >/= 1,500/microL; c. Platelets >/= 100,000/Ul; d. Serum creatinine </= 1.5 mg/dL Hepatic function: a. AST (SGOT)/ALT (SGPT) </= 5 X institutional (Upper Limit of Normal) ULN Operable patients Completion of neoadjuvant systemic chemotherapy Patients will be informed and a signed consent before initiating any procedure specific to the trial Exclusion Criteria: Cancers of non colorectal origin Patients presenting with a detectable recurrent tumour History of cancer (excepted cutaneous basal cell carcinoma or in situ carcinoma of the uterine cervix) with a recurrence during the 5 previous years Known HIV, Hepatitis B or Hepatitis C positive Pregnant women or likely to be pregnant Persons under guardianship Subjects deemed unable to comply with study and/or follow-up procedures. Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kefeng Ding, Prof.
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Union Hospital Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
Liaoning Cancer Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
The First Affiliated Hospital of College of Medicine Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Second Affiliated Hospitalof Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Jinhua People's Hospital
City
Jinhua
State/Province
Zhejiang
ZIP/Postal Code
321000
Country
China
Facility Name
People's Hospital of Shaoxing
City
Shaoxing
State/Province
Zhejiang
ZIP/Postal Code
312000
Country
China
Facility Name
Yuyao People's Hospital
City
Yuyao
State/Province
Zhejiang
ZIP/Postal Code
315400
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Surgery With HIPEC in Treating Patients With a High Risk of Developing Colorectal Peritoneal Carcinomatosis

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