Recurrence after resection for colon cancer MedDRA version: 20.0 Level: PT Classification code 10009944 Term: Colon cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: OXALIPLATIN
CAS Number: 61825-94-3
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equ
Sponsors
Kirurgisk Afdeling A, Odense Universitetshospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Radically resected colon cancer patients with adeno- or signet ring cell carcinomas with high-risk tumors defined as: perforated / pT4NanyM0 (UICC 8th edition) / pTanyNanyM1 with radically resected PM including ovarian metastases • Performance status 0-1 • Fertile women must use approved contraceptives (see below) Version 1, 18.06.2017 7 • Age > 18 years • Written 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Radiologically or clinically proven relapse. • Previous cytoreductive surgery (CRS) with HIPEC • Other malignant diagnosis within the last 2 years • Contraindications to laparoscopy (e.g. severe adhesions, peritonitis) • A history of allergic reaction to oxaliplatin or other platinum containing compounds • Renal impairment, defined as GFR 2. • Impaired liver function defined as bilirubin = 1.5 x UNL (upper normal limit). • Inadequate haematological function defined as ANC = 1.5 x 109/l and platelets = 100 x 109/l. • Any other condition or therapy, which in the investigator’s opinion may pose a risk to the patient or interfere with the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The proportion of patients with peritoneal recurrence on contrast enhanced CT of the thorax and abdomen 36 months after resection of high-risk colon cancer.;Secondary Objective: • The number of conversions from positive to negative peritoneal lavage cytology after one PIPAC procedure. • Completion rate of two adjuvant PIPAC treatments • Treatment related toxicity and complication rate • 1- and 2-year peritoneal recurrence free survival, based on CT of the thorax and abdomen. • 1-, 2- and 3-year recurrence free survival, based on CT of the thorax and abdomen • 1-, 3- and 5-year overall survival rate;Primary end point(s): An estimated 25 % of patients with a pT4 or perforated primary colon tumor are expected to develop PM. Based on the preliminary results of PIPAC we expect an absolute risk reduction of 15% in an adjuvant setting.;Timepoint(s) of evaluation of this end point: 36 months from colon resection | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Peritoneal recurrence free survival 2. Overall survival;Timepoint(s) of evaluation of this end point: 1. 12 and 24 months 2. 60 months | — |
Countries
Denmark
Contacts
Public ContactMartin Graversen
Odense University Hospital
Outcome results
None listed