Clinical trial · Interventional
Surgery With HIPEC in Treating Patients With a High Risk of Developing Colorectal Peritoneal Carcinomatosis
Randomized Multicentric Phase III Trial Comparing Simple Surgery to Surgery Plus HIPEC (Hyperthermic Intraperitoneal Chemotherapy) With MMC in Colorectal Patients Who Have a High Risk of Developing Colorectal Peritoneal Carcinomatosis
NCT02179489CI-TRIAL-00059327completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Multicentric randomised trial. The goal of this clinical research study is to learn if hyperthermic intraperitoneal chemotherapy (HIPEC) will help to decrease the rate of peritoneal carcinomatosis(PC) in patients with high risk of developing PC of colorectal cancer. The safety of this treatment will also be studied.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4 | — | UNRESOLVED | — |
| Peritoneal Carcinomatosis | Peritoneal Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMC | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- surgery alone
- type
- EXPERIMENTAL
- label
- Hipec
- description
- Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMC
- interventionNames
- Procedure: Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMC
Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- Three years from the date of randomization
- description
- DFS
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria:
* Patients presenting with the following history:
1. Histologically-proven colorectal adenocarcinoma
2. Presenting at the time of resection of the primary with one of the following 5 criteria (criteria indicating a high risk of developing PC) :
* Minimal PC, resected at the same time as the primary
* Rupture of the primary tumour inside the peritoneal cavity,
* Intraoperative rupture of the primary tumour during surgery
* Histologically-proven T4 colorectal adenocarcinoma
* Who have received standard systemic adjuvant chemotherapy (6 months of systemic chemotherapy) :
1. Chemotherapy with FOLFOX4, mFOLFOX6, CapeOx or Capecitabine(the current standard treatment; it can be modified in the future in the two groups, if the standard is modified)
2. Given on an intent-to-treat basis (it can be stopped prematurely for miscellaneous reasons)
* Patients who do not present any sign of tumour recurrence at the end of these 6 months of chemotherapy
* Patients with the following general characteristics:
1. Age between 18 and 75 years
2. Performance Status (ECOG) 0, 1 or 2, life expectancy \> 12 weeks
3. Adequate renal, and bone marrow function: a. Leukocytes \>/= 3,000/microL; b. Absolute neutrophil count \>/= 1,500/microL; c. Platelets \>/= 100,000/Ul; d. Serum creatinine \</= 1.5 mg/dL
4. Hepatic function: a. AST (SGOT)/ALT (SGPT) \</= 5 X institutional (Upper Limit of Normal) ULN
5. Operable patients
6. Completion of neoadjuvant systemic chemotherapy
* Patients will be informed and a signed consent before initiating any procedure specific to the trial
Exclusion Criteria:
1. Cancers of non colorectal origin
2. Patients presenting with a detectable recurrent tumour
3. History of cancer (excepted cutaneous basal cell carcinoma or in situ carcinoma of the uterine cervix) with a recurrence during the 5 previous years
4. Known HIV, Hepatitis B or Hepatitis C positive
5. Pregnant women or likely to be pregnant
6. Persons under guardianship
7. Subjects deemed unable to comply with study and/or follow-up procedures.
8. Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacityReferences
Publications (0)
Data not yet available
No reference posted for this study.