Colo-rectal Cancer Clinical Trial
Official title:
Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients - The PIPAC-OPC3 CC Trial
Verified date | October 2022 |
Source | Odense University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this study, patients will be offered two Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) treatments with oxaliplatin after primary resection and standard adjuvant chemotherapy (if indicated) for colon cancer. Furthermore, the study will explore, whether it is possible to find free intraperitoneal tumor cells (FITC) after resection and adjuvant chemotherapy for colon cancer.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | March 1, 2027 |
Est. primary completion date | October 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) - Age > 18 years - Written informed consent 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Odense PIPAC Center, Department of Surgery, Odense University Hospital | Odense |
Lead Sponsor | Collaborator |
---|---|
Michael Bau Mortensen |
Denmark,
Demtröder C, Solass W, Zieren J, Strumberg D, Giger-Pabst U, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy with oxaliplatin in colorectal peritoneal metastasis. Colorectal Dis. 2016 Apr;18(4):364-71. doi: 10.1111/codi.13130. — View Citation
Solass W, Kerb R, Mürdter T, Giger-Pabst U, Strumberg D, Tempfer C, Zieren J, Schwab M, Reymond MA. Intraperitoneal chemotherapy of peritoneal carcinomatosis using pressurized aerosol as an alternative to liquid solution: first evidence for efficacy. Ann Surg Oncol. 2014 Feb;21(2):553-9. doi: 10.1245/s10434-013-3213-1. Epub 2013 Sep 5. — View Citation
van Gestel YR, de Hingh IH, van Herk-Sukel MP, van Erning FN, Beerepoot LV, Wijsman JH, Slooter GD, Rutten HJ, Creemers GJ, Lemmens VE. Patterns of metachronous metastases after curative treatment of colorectal cancer. Cancer Epidemiol. 2014 Aug;38(4):448-54. doi: 10.1016/j.canep.2014.04.004. Epub 2014 May 17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The number of patients with peritoneal recurrence | Based on contrast enhanced CT of the thorax and abdomen 36 months after resection of high-risk colon cancer. | 3 years | |
Secondary | The number of conversions from positive to negative peritoneal lavage cytology | Peritoneal lavage cytology will be performed during each PIPAC treatment in order to detect free intraperitoneal tumor cells. Interval of 5 weeks between each PIPAC. | 5 weeks | |
Secondary | Number of patients where the planned PIPAC procedures are completed | Two PIPAC procedures are planned. | 5 weeks | |
Secondary | Number of patients with treatment related toxicity or complications | Based on CTCAE (vers. 4.0) and Dindo-Clavien´s surgical complications assessment. | 3 months | |
Secondary | 1- and 2-year peritoneal recurrence free survival | Based on CT of the thorax and abdomen performed 12- and 24 months after primary resection | 2 years | |
Secondary | 1-, 2- and 3-year recurrence free survival, | Based on CT of the thorax and abdomen performed 12-, 24 and 36 months after primary resection | 3 years | |
Secondary | 1-, 3- and 5-year overall survival rate | Based on the Danish Civil Registration System | 5 years |
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