Colorectal Cancer
Conditions
Keywords
hyperthermic chemotherapy, intraperitoneal chemotherapy, second-look laparoscopy, peritoneal carcinosis, mucinous colorectal cancer
Brief summary
The purpose of this study is to evaluate whether a second-look laparoscopy, followed by peritonectomy, hyperthermic intraperitoneal chemotherapy (HIPEC) or systemic chemotherapy in case of peritoneal carcinosis, improves the overall survival of patients who have had radical resection of mucinous colorectal cancer.
Detailed description
Patients will be entered into the study after radical resection of mucinous colorectal cancer, and reevaluated by CT scan after 6 months. Patients with no evidence of disease will be randomized to receive either standard follow up, or to have a second look laparoscopy to evaluate for peritoneal carcinosis. After laparoscopy, those patients who do not have peritoneal carcinosis will continue with standard follow up. Patients with peritoneal carcinosis diagnosed by laparoscopy will be treated according to their peritoneal carcinosis index (PCI). For patients with PCI \> 20, systemic chemotherapy will be given according to Italian Association of Medical Oncology (AIOM) guidelines. Patients with PCI \< 20 will undergo peritonectomy and then receive intravenous chemotherapy immediately followed by HIPEC.
Interventions
PROCEDURELaparoscopy
second look laparoscopy to evaluate for peritoneal carcinosis
PROCEDUREperitonectomy
for patients with PCI \< 20
DRUGFolinic Acid
20 mg/m2 IV given just before HIPEC for patients with PCI \< 20
DRUG5-Fluorouracil
400 mg/m2 IV given just before HIPEC in patients with PCI \< 20
DRUGOxaliplatin
460 mg/m2 intraperitoneal hyperthermic perfusion for patients with PCI \< 20
DRUGsystemic chemotherapy
according to national Italian (AIOM) guidelines and may include biotherapies for patients with PCI \> 20
Sponsors
National Cancer Institute, Naples
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Histologic diagnosis colorectal adenocarcinoma * Mucinous histotype * Stage I-III * Radical (R0) surgical resection of primary tumor * CT scan with contrast showing no evidence of disease recurrence 6 months after primary surgery * Age ≥ 18 ≤ 65 years * Performance Status ECOG ≤1 * Normal hepatic, renal and hematologic function * Adjuvant chemotherapy permitted * Signed informed consent
Exclusion criteria
* Residual disease after surgical resection of primary tumor * Distant metastasis * Active systemic infection * Chronic cardiovascular illness that would contraindicate abdominal dilatation with pneumoperitoneum * Concomitant or previous malignancy with 5 years of surgical resection of primary tumor (except for adequately treated non-melanoma skin cancer and in situ cervical cancer) * Pregnancy or lactation * Refusal or incapability of providing informed consent * Impossibility of complying with study schedules and follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | two years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of patients with radiologic evidence of disease after initial surgery | 6 months | — |
| number of patients with peritoneal carcinosis diagnosed at laparoscopy in the experimental arm | 6 months | — |
| worst grade adverse event per patient | 7 months | toxicity measured only in experimental arm, weekly from randomization to 30 days after experimental treatment |
| overall survival | five years | — |
| list of therapies and clinical outcomes of patients who had radiologic evidence of disease within 6 months after initial surgery | two years | description of therapies and outcomes for those patients who were not randomized due to presence of disease |
| changes in quality of life | 6 months | quality of life is measured at baseline and 6 months after randomization |
Countries
Italy
Contacts
Primary ContactFrancesco Perrone, M.D., Ph.D.
Backup ContactMarilina Piccirillo, M.D.
Outcome results
None listed