NCT02179489

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

Completed NA Last updated 27 June 2022

What this trial tests

NA trial testing Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMC in Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4 in 271 participants. Completed in 30 November 2021.

Timeline

1 November 2014

Primary endpoint
30 November 2021

30 November 2021

Quick facts

Lead sponsor	Zhejiang University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	271
Start date	1 November 2014
Primary completion	30 November 2021
Estimated completion	30 November 2021
Sites	9 locations across China

Drugs / interventions tested

• Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMC

Conditions studied

• Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4 — all drugs for Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4 →
• Peritoneal Carcinomatosis — all drugs for Peritoneal Carcinomatosis →

Sponsor

Zhejiang University

Who can join

Adults 18 to 75, any sex, with Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4 or Peritoneal Carcinomatosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Colorectal peritoneal metastases: Optimal management review.
   Sánchez-Hidalgo JM, Rodríguez-Ortiz L, Arjona-Sánchez Á, Rufián-Peña S, et al · · 2019 · cited 78× · PMID 31367152 · DOI 10.3748/wjg.v25.i27.3484
2. Second and third look laparoscopy in pT4 colon cancer patients for early detection of peritoneal metastases; the COLOPEC 2 randomized multicentre trial.
   Bastiaenen VP, Klaver CEL, Kok NFM, de Wilt JHW, et al · · 2019 · cited 21× · PMID 30898098 · DOI 10.1186/s12885-019-5408-8
3. Randomized controlled trials evaluating cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in prevention and therapy of peritoneal metastasis: a systematic review.
   Eveno C, Pocard M. · · 2016 · cited 20× · PMID 30911621 · DOI 10.1515/pp-2016-0027
4. Colorectal cancer at high risk of peritoneal metastases: long term outcomes of a pilot study on adjuvant laparoscopic HIPEC and future perspectives.
   Klaver CEL, Stam R, Sloothaak DAM, Crezee J, et al · · 2017 · cited 18× · PMID 28881641 · DOI 10.18632/oncotarget.17158
5. Colorectal Cancer with Peritoneal Metastases: The Impact of the Results of PROPHYLOCHIP, COLOPEC, and PRODIGE 7 Trials on Peritoneal Disease Management.
   Sommariva A, Tonello M, Coccolini F, De Manzoni G, et al · · 2022 · cited 15× · PMID 36612161 · DOI 10.3390/cancers15010165
6. The Role of Prophylactic and Adjuvant Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Prevention of Peritoneal Metastases in Advanced Colorectal Cancer.
   Sun BJ, Daniel SK, Lee B. · · 2023 · cited 8× · PMID 37892582 · DOI 10.3390/jcm12206443
7. Current Research and Development in Hyperthermic Intraperitoneal Chemotherapy (HIPEC)-A Cross-Sectional Analysis of Clinical Trials Registered on ClinicalTrials.gov.
   Ukegjini K, Guidi M, Lehmann K, Süveg K, et al · · 2023 · cited 7× · PMID 37046587 · DOI 10.3390/cancers15071926
8. Hyperthermic intraperitoneal chemotherapy and colorectal cancer: From physiology to surgery.
   Ammerata G, Filippo R, Laface C, Memeo R, et al · · 2022 · cited 7× · PMID 36338235 · DOI 10.12998/wjcc.v10.i30.10852