E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Recurrence after resection for colon cancer |
|
E.1.1.1 | Medical condition in easily understood language |
Recurrence after resection for colon cancer |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10009944 |
E.1.2 | Term | Colon cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
• 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 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
|
E.4 | Principal 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 < 50 ml/min, (Cockcroft-Gault Equation).
• Myocardial insufficiency, defined as NYHA class > 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. |
|
E.5 End points |
E.5.1 | 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. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
36 months from colon resection |
|
E.5.2 | Secondary end point(s) |
1. Peritoneal recurrence free survival
2. Overall survival |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. 12 and 24 months
2. 60 months |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
End of trial will be 5 years after colon resection, where survival data will be analysed. LVLS will be earlier, as this will be the CT 36 months after resection. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |