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Prophylactic HIPEC for Colorectal Cancers at High Risk of Developing Peritoneal Metastases

Primary Purpose

Colorectal Cancer, Peritoneal Metastases

Status

Unknown status

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

HIPEC

About this trial

This is an interventional prevention trial for Colorectal Cancer

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Two groups of patients may be enrolled:

Group 1 patients are identified pre-operatively on radiological imaging, while Group 2 patients are identified post-operative based on histological findings.

All patients diagnosed with adenocarcinoma of the colon and rectum, and either one of the five following risk factors for peritoneal metastases will be considered for inclusion:

T4 tumours - in Group 1, this would consist of obvious clinical T4 stage based on preoperative imaging, and in Group 2, this would be on pathological confirmation of a T4 tumour.
Krukenburg tumours - Unilateral or bilateral ovarian masses seen on preoperative imaging
Perforated tumours - in Group 1, this would consist of patients presenting with perforation on preoperative imaging, and undergoing curative resection, and in Group 2, this would be on pathological or intra-operative confirmation of a perforated tumour.
Limited synchronous peritoneal metastases (peritoneal nodules <1cm in the omentum and/or close to the tumour). Patients with limited peritoneal disease in close proximity to the primary tumour, that may be removed enbloc with the primary resection can be included, but patients with more extensive peritoneal disease and those with extra-peritoneal metastases i.e. liver and/or lung metastases will be excluded from the study.
Positive cytology in Group 2 patients

Other inclusion criteria:

Patients must be between the ages of 21 and 75 years
Patients must be in a stable clinical condition to undergo simultaneous HIPEC after the primary curative colorectal resection
Patients must have an ECOG performance status 0 or 1
Patients must have normal organ and marrow function as defined below:

i. Absolute neutrophil count > 1.5 x 109/L ii. Platelets > 100 x 109/L iii. Haemoglobin > 9.0g/dl iv. Total bilirubin ≤1.5 x ULN v. AST(SGOT)/ALT(SGPT) < 3 X institutional ULN vi. Creatinine ≤1.5 x upper limit of normal (ULN) OR vii. Creatinine clearance ≥60 mL/min for patients with creatinine levels >1.5 x institutional UL e. Patients must have a normal coagulation profile f. Patients must give written informed consent

Exclusion Criteria:

Patients who are not fit to give consent for the procedure
Patients who are not fit to undergo surgery
Patients who are pregnant
Patients who have extensive synchronous peritoneal disease
Patients with extra-peritoneal metastases i.e. liver and/or lung metastases

Sites / Locations

National Cancer Centre SingaporeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group 1

Group 2

Arm Description

Patients are identified pre-operatively on radiological imaging. Prophylactic HIPEC will be delivered intra-operatively, immediately after the resection of the primary tumour, and only if the patient is deemed well enough to receive the HIPEC.

Patients are identified post-operative based on histological findings. They will be counselled to receive prophylactic HIPEC only. If peritoneal nodules are found during surgery, these patients will be excluded from the study.

Outcomes

Primary Outcome Measures

The number of patients completing the treatment

Time to adjuvant systemic chemotherapy

To evaluate if there is delay to adjuvant treatment

Secondary Outcome Measures

Full Information

NCT ID

NCT03422432

First Posted

January 30, 2018

Last Updated

February 2, 2018

Sponsor

National Cancer Centre, Singapore

1. Study Identification

Unique Protocol Identification Number

NCT03422432

Brief Title

Prophylactic HIPEC for Colorectal Cancers at High Risk of Developing Peritoneal Metastases

Official Title

Pilot Study: Prophylactic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Colorectal Cancers at High Risk of Developing Peritoneal Metastases

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

September 28, 2017 (Actual)

Primary Completion Date

May 31, 2018 (Anticipated)

Study Completion Date

May 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cancer Centre, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study investigators hypothesize that prophylactic HIPEC is feasible and well tolerated in patients with colorectal cancers with high-risk of developing peritoneal recurrence. The aim of the pilot study is to test the feasibility of performing prophylactic HIPEC for colorectal cancer patients at high-risk of developing peritoneal recurrence in our institution, and determine the morbidity associated with such a procedure. Patients with high-risk of developing peritoneal recurrence are defined as patients with tumours involving the serosa and adjacent viscera (i.e. T4 cancers) krukenburg tumours (i.e. ovarian metastases) perforated tumours positive peritoneal fluid cytology minimal synchronous PC (nodules <1cm in the omentum and/or close to the primary tumour). The study investigators plan to assess feasibility according to The number of patients completing the treatment Time to adjuvant systemic chemotherapy, to evaluate if there is delay to adjuvant treatment Morbidity will be measured according to the Clavien-Dindo Classification, and graded according to low versus high grade morbidity. If prophylactic HIPEC is shown to be feasible, with acceptable morbidity, the investigators aim to carry out a randomized controlled trial to determine the effectiveness of prophylactic HIPEC in preventing the development of peritoneal metastases in patients with colorectal cancer at high risk of peritoneal recurrence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer, Peritoneal Metastases

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

HIPEC

Intervention Description

All HIPEC will be with Mitomycin C and given at a dose of 10mg/body surface area.

Primary Outcome Measure Information:

Title

The number of patients completing the treatment

Time Frame

From start to end of study, approximately 1 year

Title

Time to adjuvant systemic chemotherapy

Description

To evaluate if there is delay to adjuvant treatment

Time Frame

3 months from date of surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Two groups of patients may be enrolled: Group 1 patients are identified pre-operatively on radiological imaging, while Group 2 patients are identified post-operative based on histological findings. All patients diagnosed with adenocarcinoma of the colon and rectum, and either one of the five following risk factors for peritoneal metastases will be considered for inclusion: T4 tumours - in Group 1, this would consist of obvious clinical T4 stage based on preoperative imaging, and in Group 2, this would be on pathological confirmation of a T4 tumour. Krukenburg tumours - Unilateral or bilateral ovarian masses seen on preoperative imaging Perforated tumours - in Group 1, this would consist of patients presenting with perforation on preoperative imaging, and undergoing curative resection, and in Group 2, this would be on pathological or intra-operative confirmation of a perforated tumour. Limited synchronous peritoneal metastases (peritoneal nodules <1cm in the omentum and/or close to the tumour). Patients with limited peritoneal disease in close proximity to the primary tumour, that may be removed enbloc with the primary resection can be included, but patients with more extensive peritoneal disease and those with extra-peritoneal metastases i.e. liver and/or lung metastases will be excluded from the study. Positive cytology in Group 2 patients Other inclusion criteria: Patients must be between the ages of 21 and 75 years Patients must be in a stable clinical condition to undergo simultaneous HIPEC after the primary curative colorectal resection Patients must have an ECOG performance status 0 or 1 Patients must have normal organ and marrow function as defined below: i. Absolute neutrophil count > 1.5 x 109/L ii. Platelets > 100 x 109/L iii. Haemoglobin > 9.0g/dl iv. Total bilirubin ≤1.5 x ULN v. AST(SGOT)/ALT(SGPT) < 3 X institutional ULN vi. Creatinine ≤1.5 x upper limit of normal (ULN) OR vii. Creatinine clearance ≥60 mL/min for patients with creatinine levels >1.5 x institutional UL e. Patients must have a normal coagulation profile f. Patients must give written informed consent Exclusion Criteria: Patients who are not fit to give consent for the procedure Patients who are not fit to undergo surgery Patients who are pregnant Patients who have extensive synchronous peritoneal disease Patients with extra-peritoneal metastases i.e. liver and/or lung metastases

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Grace Tan, MD

Phone

+65 6436 8000

grace.tan.h.c@singhealth.com.sg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Grace Tan, MD

Organizational Affiliation

National Cancer Centre, Singapore

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Centre Singapore

City

Singapore

ZIP/Postal Code

169610

Country

Singapore

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Grace Tan, MD

Phone

+65 6436 8000

grace.tan.h.c@singhealth.com.sg

First Name & Middle Initial & Last Name & Degree

Grace Tan, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Prophylactic HIPEC for Colorectal Cancers at High Risk of Developing Peritoneal Metastases

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