Clinical trial NCT02965248: Adjuvant Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Versus no HIPEC in Locally Advanced Colorectal Cancer (APEC Study)
Official title: Multicenter, Randomized Controlled Trial 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 (APEC Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Locally Advanced Colorectal Cancer
Keywords: Locally advanced colorectal cancer
Hyperthermic intraperitoneal chemotherapy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2016-11-16
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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) ≥ 1.5×10\^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

Primary outcomes:
measure: peritoneal metastasis rate
timeFrame: 3 years
Secondary outcomes:
measure: liver metastasis rate
timeFrame: 3 years
measure: disease free survival
timeFrame: 3 years
measure: overall survival
timeFrame: 5 years
measure: quality of life questionnaire
timeFrame: 6 months
measure: Toxicity by NCI CTCAE v.4.0
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Guoxiang Cai, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: