NCT03221608

Brief Summary

This multicentric study aims to determine if hyperthermic intraperitoneal chemotherapy (HIPEC) will help to prevent the development of peritoneal carcinomatosis in addition to the standard adjuvant systemic treatment after surgery.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2017

Longer than P75 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

July 18, 2017

Status Verified

July 1, 2017

Enrollment Period

4 years

First QC Date

July 17, 2017

Last Update Submit

July 17, 2017

Conditions

Colorectal Neoplasms

Keywords

Colorectal CancerHIPECPeritoneal CarcinomatosisLobaplatin

Outcome Measures

Primary Outcomes (1)

  • Incidence of endoperitoneal recurrence at 36 months

    36 months

Secondary Outcomes (7)

  • Disease-free survival (DFS)

    3 years

  • Disease-free survival (DFS)

    5 years

  • Overall survival (OS)

    3 years

  • Overall survival (OS)

    5 years

  • Quality of life

    3 years

  • +2 more secondary outcomes

Study Arms (2)

surgery alone(open/laparoscopic)

ACTIVE COMPARATOR

The patients with colorectal cancer (T4N0-2M0) who have a high risk of developing colorectal Peritoneal Carcinomatosis (PC) undergo curative surgery(open/laparoscopic).

Procedure: Surgery without HIPEC

surgery and HIPEC

EXPERIMENTAL

Standard surgical treatment and HIPEC with Lobaplatin.

Procedure: Surgery and HIPEC with Lobaplatin

Interventions

Surgery and HIPEC with LobaplatinPROCEDURE

The combination of surgery and HIPEC with Lobaplatin are performed in patients with colorectal cancer (T4N0-2M0).

Also known as: The combination of surgery and HIPEC with Lobaplatin
surgery and HIPEC
Surgery without HIPECPROCEDURE

The patients with colorectal cancer (T4N0-2M0) are undergone a curative resection by laparoscopy or open approach.

Also known as: Standard surgical treatment by laparoscopy or open approach.
surgery alone(open/laparoscopic)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically-proven colorectal adenocarcinoma
  • Patients with colon cancer or intraperitoneal rectal cancer with clinical (by CT) T4 tumors, any N, M0
  • Signed informed consent
  • White blood cell count of at least 3000/mm3, platelet count of at least 100.000/mm3
  • No bleeding diathesis or coagulopathy
  • Patients without chemotherapy, radiation or other anti-cancer treatment before the clinical trial

You may not qualify if:

  • Liver and/or lung metastases
  • Pregnant women or likely to be pregnant
  • Severe hepatic and / or renal dysfunction
  • Impossibility of an adequate follow-up
  • Without history of cancer during last 5 years
  • Other concurrent chemotherapy
  • Severe or uncontrolled mental illness
  • Patients with epilepsy required to be treated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal NeoplasmsPeritoneal Neoplasms

Interventions

Surgical Procedures, OperativeHyperthermic Intraperitoneal Chemotherapylobaplatin

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesAbdominal NeoplasmsPeritoneal Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, AdjuvantCombined Modality TherapyTherapeuticsDrug TherapyHyperthermia, Induced

Study Officials

  • MeiJin Huang, MD

    Sixth Affiliated Hospital, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

MeiJin Huang, MD

CONTACT

86-020-38250745meijinhuang3@163.com

Wei Chen, MD

CONTACT

86-020-38250745chenw47@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 17, 2017

First Posted

July 18, 2017

Study Start

August 1, 2017

Primary Completion

August 1, 2021

Study Completion

August 1, 2024

Last Updated

July 18, 2017

Record last verified: 2017-07