Clinical trial · Interventional
Standard Therapy With or Without Surgery and Mitomycin C in Treating Patients With Advanced Limited Peritoneal Dissemination of Colon Cancer
Pilot / Phase III Randomized Trial Comparing Standard Systemic Therapy to Cytoreduction + Hyperthermic Intraperitoneal Mitomycin C + Standard Systemic Therapy in Patients With Limited Peritoneal Dissemination of Colon Adenocarcinoma
- 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)
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Heating mitomycin C to several degrees above normal body temperature and infusing it into the area around the tumor may kill more tumor cells. Giving mitomycin C after surgery may kill any remaining tumor cells. It is not yet known whether standard therapy is more effective with or without surgery followed by mitomycin C. PURPOSE: This randomized phase III trial is studying standard therapy with or without surgery and mitomycin C in treating patients with advanced limited peritoneal dissemination of colon cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Biological | Bevacizumab | ALIAS |
| capecitabine | Drug | Capecitabine | ALIAS |
| cetuximab | Biological | Cetuximab | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| FOLFIRI regimen | Drug | FOLFIRI Regimen | ALIAS |
| FOLFOX regimen | Drug | FOLFOX Regimen | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I
- description
- Patients receive standard systemic therapy, at the discretion of patients' oncologist, comprising combinations of fluorouracil, leucovorin calcium, irinotecan hydrochloride, oxaliplatin, and/or capecitabine (including FOLFOX4, mFOLFOX6, CapeOx, or FOLFIRI), bevacizumab, or cetuximab. Treatment repeats in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may crossover to arm II.
- interventionNames
- Biological: bevacizumab
- Biological: cetuximab
- Drug: FOLFIRI regimen
- Drug: FOLFOX regimen
- Drug: capecitabine
- Drug: fluorouracil
- Drug: irinotecan hydrochloride
- Drug: leucovorin calcium
- Drug: oxaliplatin
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients undergo cytoreduction surgery and hyperthermic intraperitoneal mitomycin C over 45-90 minutes. Beginning 8 weeks after surgery, patients receive standard systemic therapy as in arm I. Treatment with systemic therapy repeats for 6 courses in the absence of disease progression or unacceptable toxicity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed colon adenocarcinoma meeting the following criteria: * Newly diagnosed disease * Advanced disease * Confirmed synchronous or metachronous limited peritoneal disease dissemination * No appendiceal or rectal cancer * No signet ring cell type * Disease amenable to complete cytoreduction surgery as indicated by: * Peritoneal Cancer Index (PCI) ≤ 20 by helical CT scan and/or staging laparoscopy * No parenchymal hepatic metastases * No clinical (jaundice), biochemical (abnormally elevated serum bilirubin and/or alkaline phosphatase), or radiological (by ultrasound, CT scan, or MRI) biliary obstruction * No symptomatic malignant ascites requiring palliative paracentesis * Small volume of disease in the gastro-hepatic ligament defined by a \< 5 cm mass in the epigastric region on cross-sectional imaging * No cross-sectional imaging findings indicative of multi-segmental (\> 1 site) small bowel obstruction, small bowel loops matted together, or gross disease of the small bowel mesentery characterized by distortion, thickening, or loss of mesenteric vascular clarity * No clinical or radiological evidence of hematogenous or distant nodal (retroperitoneal, pelvic, mediastinal, peri-portal, or peri-aortic) metastasis PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * ANC \> 1,200/mm³ * WBC \> 4,000/mm³ * Platelet count 150,000/mm³ * INR ≤ 1.5 * Patients on therapeutic anticoagulant for unrelated medical condition such as atrial fibrillation or anti-thrombocyte treatment allowed provided treatment can be withheld for operation * Total serum bilirubin ≤ 1.5 mg/dL (\> 1.5 mg/dL for patients with Gilbert syndrome) * Alkaline phosphatase \< 2.5 times upper limit of normal (ULN) * AST \< 1.5 times ULN * Serum creatinine normal * BUN normal * Not pregnant or nursing * Fertile patients must use effective contraception * No history of severe congestive heart failure or severe pulmonary disease * Patients who are status post-revascularization procedures with satisfactory cardiac function are eligible * No acute myocardial infarction within the past 6 months * No significant history of a medical problem or co-morbidity (e.g., severe congestive heart failure or active ischemic heart disease) that would preclude a major abdominal operation * No concurrent second malignancy requiring systemic therapy * No psychiatric or addictive disorders, or other conditions that would preclude the patient from meeting the study requirements PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior second-line systemic treatment for metastatic colon adenocarcinoma * Patients who received prior adjuvant therapy for colon adenocarcinoma and/or prior first-line systemic therapy for metastatic colon adenocarcinoma are eligible
References
Publications (0)
Data not yet available