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

NCT02179489 | Completed DMC

• 1 other identifier: CRCCZ-C01
• Study Type: interventional
• Target: 271
• Locations: 1 country
• Sites: 9

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.

Conditions

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

Keywords

Peritoneal carcinomatosis; HIPEC; controlled clinical trial; colorectal cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  DFS

  Three years from the date of randomization

Secondary Outcomes (5)

• 3 year overall survival

  3 years

• Peritoneal disease-free survival

  3 years

• 5 year overall survival

  5 years

• morbidity

  Baseline before any treatment,3 months post operation, 1 year post operation

• QOL

  Baseline before any treatment,3 months post operation, 1 year post operation

Study Arms (2)

Control

NO INTERVENTION

surgery alone

Hipec

EXPERIMENTAL

Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMC

Procedure: Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMC

Interventions

Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMC PROCEDURE

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.

Hipec

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (9)

Union Hospital Fujian Medical University

Fuzhou, Fujian, 350001, China

Location

Liaoning Cancer Hospital

Shenyang, Liaoning, 110042, China

Location

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

The First Affiliated Hospital of College of Medicine Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Second Affiliated Hospitalof Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

Location

Jinhua People's Hospital

Jinhua, Zhejiang, 321000, China

Location

People's Hospital of Shaoxing

Shaoxing, Zhejiang, 312000, China

Location

Yuyao People's Hospital

Yuyao, Zhejiang, 315400, China

Location

MeSH Terms

Conditions

Peritoneal Neoplasms; Colorectal Neoplasms

Interventions

Surgical Procedures, Operative; Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Officials

• Kefeng Ding, Prof.

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: June 21, 2014
• First Posted: July 1, 2014
• Study Start: November 1, 2014
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: June 27, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)