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Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients

ConditionsPeritoneum CancerPeritoneal CarcinomatosisPeritoneal MetastasesColo-rectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMichael Bau Mortensen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • PIPAC

    Drug

    PIPAC is performed during a standard laparoscopy with a capnoperitoneum of 12 mmHg. During PIPAC, oxaliplatin 46 mg/m2 in 150 ml dextrose will be intraperitoneally nebulized at a rate of 0.5 ml/s with a maximum pressure of 200 PSI. The intraperitoneal air will be evacuated after 30 minutes of simple diffusion

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: InterventionalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 years

Secondary outcomes

1

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.

Time frame
5 weeks
2

Number of patients where the planned PIPAC procedures are completed

Two PIPAC procedures are planned.

Time frame
5 weeks
3

Number of patients with treatment related toxicity or complications

Based on CTCAE (vers. 4.0) and Dindo-Clavien´s surgical complications assessment.

Time frame
3 months
4

1- and 2-year peritoneal recurrence free survival

Based on CT of the thorax and abdomen performed 12- and 24 months after primary resection

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Michael Bau Mortensen

Lead sponsor

Odense University Hospital

Sponsor institution

Source ClinicalTrials.gov
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