Colorectal CancerNCT03422432
Prophylactic HIPEC for Colorectal Cancers at High Risk of Developing Peritoneal Metastases
A study testing HIPEC in people with Colorectal Cancer and Peritoneal Metastases, run by National Cancer Centre, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Colorectal Cancer, Peritoneal Metastases
- What is being tested?
- HIPEC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSingapore
- Study dates
- 28 Sep 2017to 13 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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:
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site
National Cancer Centre Singapore
Singapore, Singapore, 169610
About this study
Official title: Pilot Study: Prophylactic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Colorectal Cancers at High Risk of Developing Peritoneal Metastases
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.
Read more
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.
- Conditions
- Colorectal Cancer, Peritoneal Metastases
- Being tested
- HIPEC
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIPECProcedure or surgery
All HIPEC will be with Mitomycin C and given at a dose of 10mg/body surface area.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 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. Receives: Procedure: HIPEC |
| Group 2 | Experimental | 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. Receives: Procedure: HIPEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients completing the treatment
Measured: From start to end of study, approximately 1 year
Time to adjuvant systemic chemotherapy
To evaluate if there is delay to adjuvant treatment
Measured: 3 months from date of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start28 Sep 2017
- Primary completion7 Sep 2023
- Study completion13 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grace Tan, MD, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422432
- Sponsor's protocol ID
- 2017/2402/B
- Status last verified
- Jan 2025
- First submitted
- 30 Jan 2018
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Prophylactic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Colorectal Cancers at High Risk of Developing Peritoneal Metastases
- ClinicalTrials.gov ID
- NCT03422432
- Acronym / sponsor ID
- 2017/2402/B
- Conditions
- Colorectal Cancer, Peritoneal Metastases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 7 Sep 2023 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: HIPECPatients 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. |
| Group 2 | Experimental | Procedure: HIPECPatients 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. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIPECAll HIPEC will be with Mitomycin C and given at a dose of 10mg/body surface area. | Procedure or surgery | Group 1, Group 2 |
Primary outcome
The number of patients completing the treatment
Time frame: From start to end of study, approximately 1 year
Time to adjuvant systemic chemotherapy
Time frame: 3 months from date of surgery
To evaluate if there is delay to adjuvant treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace Tan, MD principal investigator
National Cancer Centre, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIPEC in people with Colorectal Cancer and Peritoneal Metastases, run by National Cancer Centre, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients completing the treatment (time frame: From start to end of study, approximately 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.