NCT02830139

Brief Summary

The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced colorectal cancer is not definite. The hypothesis of the trial is that radical colorectal resection plus HIPEC is superior to only radical colorectal resection in terms of overall survival.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

3.7 years

First QC Date

July 8, 2016

Last Update Submit

March 16, 2020

Conditions

Malignant Neoplasm of Colorectum

Outcome Measures

Primary Outcomes (1)

  • overall survival

    From the date of surgery to the date of death or to the end of follow-up

    5 years

Secondary Outcomes (5)

  • progression-free survival

    5 years

  • distant metastasis rate

    5 years

  • peritoneal metastasis rate

    5 years

  • local recurrence rate

    5 years

  • complication rate

    5 years

Study Arms (2)

Radical colorectal resection without HIPEC

SHAM COMPARATOR

Patients will be treated with a radical colorectal resection for locally advanced colorectal cancer and postoperative chemotherapy (XELOX)

Procedure: Radical colorectal resectionDrug: Oxaliplatin , CapecitabineDrug: Normal saline , Cisplatin , 5-Fu

Radical colorectal resection with HIPEC

EXPERIMENTAL

Patients will be treated with a radical colorectal resection for locally advanced colorectal cancer and HIPEC with paclitaxel and 5-Fu and postoperative chemotherapy (XELOX)

Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC)Procedure: Radical colorectal resectionDrug: Oxaliplatin , Capecitabine

Interventions

Hyperthermic intraperitoneal chemotherapy (HIPEC)PROCEDURE

Normal saline 3000ml-4000ml, Cisplatin 60mg/m2, 5-Fu 1500mg/m2, 43°C, 60min, During surgery and 7 days after surgery.

Radical colorectal resection with HIPEC
Radical colorectal resectionPROCEDURE

radical colorectal resection with lymphadenectomy

Radical colorectal resection with HIPECRadical colorectal resection without HIPEC
Oxaliplatin , CapecitabineDRUG

XELOX postoperative chemotherapy Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.

Radical colorectal resection with HIPECRadical colorectal resection without HIPEC
Normal saline , Cisplatin , 5-FuDRUG
Radical colorectal resection without HIPEC

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histological proved diagnosis of locally advanced colorectal cancer.
  • No evidence of distant metastases or peritoneal metastases.
  • Preoperative examination (CT/MRI) demonstrated resectable colorectal cancer with T3-T4 stage.
  • Eligible for radical colorectal resection with lymphadenectomy.
  • Have not received cytotoxic chemotherapy or radiotherapy.
  • Written informed consent is obtained prior to commencement of trial treatment.

You may not qualify if:

  • Existence of distant metastasis or peritoneal metastasis during surgery (M1).
  • Any previous chemotherapy or radiotherapy
  • Active systemic infections
  • Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial.
  • Female patients who are pregnant or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430021, China

Location

MeSH Terms

Interventions

Hyperthermic Intraperitoneal ChemotherapyOxaliplatinCapecitabineSaline SolutionCisplatinFluorouracil

Intervention Hierarchy (Ancestors)

Chemotherapy, AdjuvantCombined Modality TherapyTherapeuticsDrug TherapyHyperthermia, InducedCoordination ComplexesOrganic ChemicalsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cancer Center of Wuhan University

Study Record Dates

First Submitted

July 8, 2016

First Posted

July 12, 2016

Study Start

July 1, 2016

Primary Completion

March 15, 2020

Study Completion

March 15, 2020

Last Updated

March 18, 2020

Record last verified: 2020-03

Locations

CN(1)