Patterns of metachronous metastases after curative treatment of colorectal cancer.
Yvette R B M van Gestel, Ignace H J T de Hingh, Myrthe P P van Herk-Sukel...
https://pubmed.ncbi.nlm.nih.gov/24841870Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID03280511
Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients - The PIPAC-OPC3 CC Trial
Led by Michael Bau Mortensen · Updated on 2022-10-06
60
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with oxaliplatin as an additional treatment for patients with high-risk colon cancer who have undergone surgery and, if needed, standard chemotherapy. The study aims to determine if PIPAC can reduce the chance of cancer returning in the abdomen and if it can eliminate free tumor cells present after initial treatments. This Phase 2 trial addresses a significant concern since many patients experience cancer recurrence, especially in the peritoneal area, which currently has limited treatment options. The treatment involves two PIPAC sessions delivered via laparoscopy approximately two months after surgery or right after adjuvant chemotherapy. During PIPAC, oxaliplatin is aerosolized under pressure inside the abdomen to cover the entire peritoneal surface. Each treatment lasts about 30 minutes, with a 5-week gap between the two procedures. Follow-up includes CT scans at 12, 24, and 36 months to monitor for cancer recurrence. Participants will undergo laparoscopy with peritoneal lavage and biopsies as part of the treatment process. Researchers will assess the presence of free intraperitoneal tumor cells and monitor for peritoneal cancer recurrence over three years. They will also track treatment completion rates, side effects, and overall survival outcomes. The study expects to enroll about 60 patients over two years, with ongoing observation and monitoring to evaluate the impact of PIPAC on disease progression and safety.
CONDITIONS
Brief Title
Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Radically resected colon cancer patients with adenocarcinoma or signet ring cell carcinoma having high-risk tumors defined as perforated, pT4NanyM0, or pTanyNanyM1 with resected peritoneal metastases including ovarian metastases
- Performance status 0-1
- Fertile women must use approved contraceptives
- Age over 18 years
- Written informed consent
You will not qualify if you...
- Radiologically or clinically proven relapse of cancer
- Previous cytoreductive surgery with HIPEC
- Other malignant diagnosis within the last 2 years
- Contraindications to laparoscopy such as severe adhesions or peritonitis
- History of allergic reaction to oxaliplatin or other platinum compounds
- Kidney impairment with GFR less than 50 ml/min
- Heart failure classified as NYHA class greater than 2
- Impaired liver function with bilirubin 1.5 times above upper normal limit
- Low blood counts: ANC less than or equal to 1.5 x 10^9/l and platelets less than or equal to 100 x 10^9/l
- Any other conditions or therapies that may pose risk or interfere with study objectives as judged by the investigator
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 10 weeks
Participants receive two PIPAC treatments with oxaliplatin delivered via laparoscopy to prevent peritoneal metastases after colon cancer resection.
2 visits (laparoscopy procedures) spaced 5 weeks apart
Follow-up
Duration - Up to 3 years
Participants have follow-up CT scans to monitor for cancer recurrence after treatment.
3 visits (CT scans) at 12, 24, and 36 months post-treatment
Trial Site Locations
Total: 1 location
1
Odense PIPAC Center, Department of Surgery, Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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Published Research Related To This Trial
Intraperitoneal chemotherapy of peritoneal carcinomatosis using pressurized aerosol as an alternative to liquid solution: first evidence for efficacy.
Wiebke Solass, Reinhold Kerb, Thomas Mürdter...
https://pubmed.ncbi.nlm.nih.gov/24006094Pressurized intraperitoneal aerosol chemotherapy with oxaliplatin in colorectal peritoneal metastasis.
C Demtröder, W Solass, J Zieren...
https://pubmed.ncbi.nlm.nih.gov/26400556Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in resected high-risk colon cancer patients - study protocol for the PIPAC-OPC3 Trial. A prospective, controlled phase 2 Study.
Martin Graversen, Sönke Detlefsen, Claus Fristrup...
https://pubmed.ncbi.nlm.nih.gov/30911655