Adjuvant Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Versus no HIPEC in Locally Advanced Colorectal Cancer (APEC Study)

  • STATUS
    Recruiting
  • End date
    Nov 22, 2023
  • participants needed
    147
  • sponsor
    Fudan University
Updated on 24 February 2022

Summary

This study is designed to evaluate the efficacy and safety of adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) with raltitrexed or oxaliplatin versus no HIPEC in locally advanced colorectal cancer

Description

Peritoneum is one of the common sites of metastasis in advanced stage colorectal cancer patients, resulting in a poor prognosis. Hyperthermic intraperitoneal chemotherapy (HIPEC) is effective to colorectal peritoneal metastasis and may play a significant role in reducing the risk of metachronous peritoneal metastasis among patients with locally advanced colorectal cancer. Oxaliplatin is routinely used for HIPEC in the Europe and Raltitrexed may be another ideal drug for HIPEC. The present phase II multicenter, randomized controlled trial is designed to evaluate the efficacy and safety of adjuvant HIPEC with raltitrexed or oxaliplatin versus no HIPEC in locally advanced colorectal cancer.

Details
Condition Locally Advanced Colorectal Cancer
Treatment Standard adjuvant systemic chemotherapy, Hyperthermic intraperitoneal chemotherapy (HIPEC) with raltitrexed, Hyperthermic intraperitoneal chemotherapy (HIPEC) with oxaliplatin
Clinical Study IdentifierNCT02965248
SponsorFudan University
Last Modified on24 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Joined the study voluntarily and signed informed consent form
Eastern Cooperative Oncology Group performance status of 0 to 1
Life expectancy of more than 5 years
Colorectal adenocarcinoma / mucinous adenocarcinoma / signet ring cell cancer confirmed by histopathology
Stage T4NanyM0 cancer; or stage T3NanyM0 mucinous adenocarcinoma / signet ring cell cancer / adenocarcinoma with partly mucinous adenocarcinoma or signet ring cell cancer
R0 resection of colorectal cancer
Neutrophils (ANC) 1.510^9/L, Platelet count (Pt) 100 10^9/L, Hemoglobin (Hb) 80 g/L, Hepatic function: ALT and AST 2.5 times upper limit of normal (ULN) and TBIL 1.5 times ULN, Renal function: creatinine 1.5 times ULN
Use of an effective contraceptive for adults to prevent pregnancy

Exclusion Criteria

Rectal cancer below peritoneal reflection ( 8cm above the anal verge)
Other malignant tumors within the past 5 years, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived from radical treatment
Severe adhesion of peritoneal cavity impossible to separate
Abdominal infection
Allergic to raltitrexed, 5-FU, and oxaliplatin; Dihydropyrimidine dehydrogenase (DPD) enzyme deficiency
Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
Drug addiction, Alcoholism or AIDS
Impossible to tolerate the operation due to severe cardiac, lung, and vascular diseases
Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
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