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

Zhejiang University271 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

271

Conditions

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

Interventions

Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMCPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (9)

Union Hospital Fujian Medical University

Fuzhou, Fujian, China

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Disease-free survival

DFS

Time frame: Three years from the date of randomization

Secondary Outcomes

3 year overall survival

3-OS

Time frame: 3 years

Peritoneal disease-free survival

PDFS

Time frame: 3 years

5 year overall survival

5-OS

Time frame: 5 years

morbidity

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

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.

Time frame: Baseline before any treatment,3 months post operation, 1 year post operation

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.