Colorectal Peritoneal Carcinomatosis
Conditions
Keywords
colorectal cancer, cytoreductive surgery, intraperitoneal chemotherapy, systemic chemotherapy, Peritoneal Metastatic Disease From the Colon or Rectum
Brief summary
The purpose of this study is to see if there is a difference in survival between two different treatment strategies for colorectal peritoneal surface disease. The control arm administered the currently considered standard treatment which is palliative systemic chemotherapy. The experimental arm received the combination treatment cytoreductive surgery and intraperitoneal chemotherapy. The investigators hypothesis is that the combination treatment will improve the overall survival.
Interventions
DRUGSystemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin)
Oxaliplatin 100 mg/ m2 as a 2 h iv infusion + 5-fluorouracil 400 mg/ m2 iv bolus + Isovorin 100 mg/ m2 as a 2 h infusion followed by 5-fluorouracil 2400 mg/ m2 as a 46 h infusion. Each cycle is given every other week until 12 cycles have been administered.
PROCEDURECytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin)
Cytoreductive surgery has the goal of completely resecting all visible tumor tissue in the abdomen. Sequential postoperative intraperitoneal chemotherapy has the purpose of an adjuvant treatment to eradicate microscopic residual tumor and prevent recurrences in the abdomen. The chemotherapy regimen consisted of intraperitoneal 5-fluorouracil 550 mg/ m2 and intravenous isovorin 30 mg/ m2 day 1-6 med cycles every 4-6 weeks. Six cycles were planned.
Sponsors
Uppsala University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Metastatic disease to the peritoneum from colon or rectum (at least two isolated sites of disease) * verified primary tumor of adenocarcinoma of the colon or rectum * Potential resectability as judged by the treating surgeon * Patient is available for follow-up according to the study protocol * Signed informed consent
Exclusion criteria
* Extraabdominal metastases or liver metastases * Paraaortic or other inoperable lymph node metastases * Clear indication for surgery only (such as obstruction, bleeding or peritonitis) * Prior treatment of either arm in the study * Clinical or histopathological diagnosis of Peritoneal Pseudomyxoma * Age \> 80 * Contraindications for chemotherapy * Pregnancy or breastfeeding * Ongoing infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | 8 years |
Secondary
| Measure | Time frame |
|---|---|
| Health costs | 8 years |
| progression free survival | 8 years |
| Quality of life | 7 years |
| Radical resectability | 5 years |
| Side effects of treatment | 6 years |
| Time to secondary treatment | 8 years |
Countries
Sweden
Outcome results
None listed