Surgical resection combined with intraperitoneal chemotherapy (CT) is the best treatment for selected patients with Peritoneal Metastases from colon cancer. However, the real role of intraperitoneal CT as a necessary component of this treatment is unknown, despite its proven experimental basis. The main objective of this study is to clarify it, so one group of patients will be treated with surgery + intraperitoneal CT and the other with surgery alone.
- Conditions
- Therapeutic area: Diseases [C] - Cancer [C04]Surgical resection combined with intraperitoneal chemotherapy (CT) is the best treatment for selected patients with Peritoneal Metastases from colon cancer. However, the real role of intraperitoneal CT as a necessary component of this treatment is unknown, despite its proven experimental basis. The main objective of this study is to clarify it, so one group of patientes will be treated with surgery + intraperitoneal CT and the other with surgery alone.
- Registration Number
- EUCTR2019-004679-37-ES
- Lead Sponsor
- Hospital Universitario de Fuenlabrada
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 216
1) Histologically confirmed colon cancer, except those with signet ring cells (> 50% of the tumor composed of these cells, only 1% of CRCs)
2) Absence of extraperitoneal metastases, including distant lymphadenopathy, liver and lung metastases (ruled out by PET in case of doubt).
3) Mild or moderate extent synchronous or metachronous peritoneal carcinomatosis with a PCI = 20 (intraoperative confirmation)
4) Obtaining a macroscopically complete surgical cytoreduction CCS-0 (intraoperative confirmation)
5) Treatment with perioperative systemic chemotherapy (before and/or after surgical procedure).
6) Age> 18 years
7) Acceptable anesthetic/surgical risk: ASA 1-3, ECOG 0-1. No severe alterations in hematological, renal and hepatic function (operable patients)
8) Information to the patient and signing of a study-specific informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 108
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 108
1) Carcinomatosis of any other origin, particularly rectal cancer or appendicular adenocarcinoma, or signet ring cell CC on histology.
2) No intraoperative confirmation of peritoneal disease (PCI 0). Likewise, cases of perianastomotic (local) or lymph node (locoregional) recurrences will be excluded.
3) High volume peritoneal carcinomatosis, with a PCI> 20 (intraoperative evaluation).
4) Concurrent or previously treated extraperitoneal disease.
5) Progression during preoperative chemotherapy, if received.
6) Patients previously treated with HIPEC.
7) History of other cancers (except cutaneous basal cell carcinoma or cervical carcinoma in situ) in the 5 years prior to entry into the study.
8) Patient included in another first-line clinical trial for the disease studied.
9) Pregnancy (or suspected of it) or lactation period.
10) Urgent intervention for obstruction or perforation.
11) Persons deprived of liberty or under guardianship.
12) Inability to understand the nature of the intervention, the risks, benefits, expected evolution and the need to undergo periodic medical examinations, either for geographical, social or psychological reasons.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess whether there are differences in PERITONEAL RECURRENCE in patients with peritoneal metastases from colon cancer treated with complete surgical resection and systemic chemotherapy, with (Group 1) or without (Group 2) intraoperative hyperthermic intraperitoneal chemotherapy;Secondary Objective: - Evaluate if there are differences in recurrence at other levels between both groups (Disease-Free Survival) <br>- Evaluate the toxicity of the treatments and compare the postoperative complications between both groups<br>- Determine prognostic factors for peritoneal recurrence and at other locations <br>- Compare the overall survival between both groups<br>- Study of the Quality of Life in both groups using the QLQ-C30 and QLQ-CR29 questionnaires of the EORTC;Primary end point(s): Peritoneal Recurrence Free Survival at 1 and 2 years.;Timepoint(s) of evaluation of this end point: 1 and 2 years after treatment with surgery +/- intraoperative hyperthermic intraperitoneal chemotherapy
- Secondary Outcome Measures
Name Time Method