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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
The study investigators plan to assess feasibility according to
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIPEC | Procedure | All HIPEC will be with Mitomycin C and given at a dose of 10mg/body surface area. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of patients completing the treatment | From start to end of study, approximately 1 year | |
| Time to adjuvant systemic chemotherapy | To evaluate if there is delay to adjuvant treatment | 3 months from date of surgery |
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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:
Other inclusion criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Grace Tan, MD | National Cancer Centre, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Centre Singapore | Singapore | Singapore | 169610 | Singapore |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000084262 | Hyperthermic Intraperitoneal Chemotherapy |
| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006979 |
| Hyperthermia, Induced |