Pressurised IntraPeritoneal Aerosolised Chemotherapy (PIPAC) in the management of cancers of the bowel, ovary and stomach: a randomised controlled trial of efficacy in peritoneal metastases

Not Applicable

• Conditions: Colorectal, ovarian and stomach cancer with peritoneal metastasis; Cancer

• Registration Number: ISRCTN17575409
• Lead Sponsor: Cardiff and Vale University Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-29
• Last Update Posted: 8 April 2024
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

All disease groups:
1. 16 years and older
2. Visible (measurable or non-measurable) peritoneal lesion(s) on computerised tomography (CT) imaging as per Response Evaluation
Criteria in Solid Tumours (RECIST) v1.1
3. Eastern Cooperative Oncology Group (ECOG) performance status 0–1
4. Adequate bone marrow, liver and kidney function (within 7 days prior to randomisation):
4.1. Neutrophil =1.5×10^9/L
4.2. White blood cells =3.0 x 10^9/L
4.3. Platelets =100×10^9/L
4.4. Haemoglobin =90 g/l
4.5. Serum bilirubin =3 x ULN
4.6. ALT/AST =2.5 x ULN (if both done, both must meet criteria)
4.7. Creatinine clearance =60 ml/min
5. Fit enough to receive full dose of systemic anti-cancer therapy (SACT) in cycle 1 as defined in the protocol.
6. Ability to provide informed consent obtained prior to any trial-specific screening procedures.

Colorectal group only:
1. PM from histologically proven primary adenocarcinoma of the colorectum.

Ovarian group only:
1. PM from histologically confirmed primary epithelial ovarian, tubal, or primary peritoneal platinum-resistant carcinoma (including clinical recurrence, refractory disease, or persistent disease within 6 months of last chemotherapy).

Stomach group only:
1. PM from histologically proven primary adenocarcinoma (any subtype) of stomach or Siewert type 3 gastro-oesophageal junction tumour (any Human Epidermal Growth Factor Receptor 2 [HER2] status or Combined Positive Score [CPS]).

Exclusion Criteria

All disease groups:
1. Any prior malignancy not considered in complete remission for at least 2 years, excluding non-melanoma skin cancer
2. Pregnant or breastfeeding
3. Untreated central nervous system disease or symptomatic central nervous system metastasis, history, or evidence of thrombotic or haemorrhagic disorders not considered currently in complete remission
4. Bevacizumab/aflibercept should not be used in either arm (minimum 4 weeks from any prior bevacizumab/aflibercept)
5. Contraindication to any drug contained in the chemotherapy regimen
6. Medical, geographical, sociological, psychological, or legal conditions that would prevent the patient from completing the study or signing the informed consent
7. Unresolved bowel obstruction or parenteral nutrition or gastric tube
8. Contraindication to surgery
9. Participating in other oncological trials that may impact on endpoint
Added 26/03/2024: 10. Life expectancy <3 months

Colorectal group only:
1. Extra-peritoneal metastases except for:
1.1. retroperitoneal lymph nodes <2cm
1.2. lung metastases; with < 5 lung metastases none >1cm
2. Eligible for and chooses cytoreductive surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) upfront
3. Prior systemic therapy for colorectal cancer in the last 6 months
4. Dihydropyrimidine Dehydrogenase Deficiency (DPYD) variant detected
5. Microsatellite instability (MSI) high
Added 26/03/2024: 6. Previous cytoreductive surgery (CRS) or Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Ovarian group only:
1. Extra-peritoneal metastases (with the exception of retroperitoneal lymph nodes)
2. Parenchymal liver or spleen metastases
3. Malignant pleural effusion
4. Non-epithelial pathology subtype
5. Peritoneal disease, amenable to surgical resection

Stomach group only:
1. Extra-peritoneal metastases (with the exception of retroperitoneal lymph nodes)
2. Prior systemic anti-cancer therapy, radiotherapy or surgery for stomach cancer
3. Gastric or duodenal stent in-situ
4. Gastro-oesophageal junction Sievert Type 1 or Type 2 tumour
5. Symptoms and/or radiology suggestive of impending and/or current bowel obstruction
6. Uncontrolled and persistent ascites
7. MSI high
8. DPYD variant detected
Added 26/03/2024: 6. Previous cytoreductive surgery (CRS) or Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Study & Design

• Study Type: Interventional
• Study Design: Not specified