Colorectal, ovarian and stomach cancer with peritoneal metastasis Cancer
Conditions
Interventions
Current interventions as of 19/06/2025:
The trial will test a new method to deliver chemotherapy as a spray, directly into the peritoneal cavity, to determine whether this improves survival in patient
all drugs used in the trial will be taken from local hospital supplies. Each disease group has specific options for the chemotherapy dose and frequency, which we have represented in our protocol with
Sponsors
Cardiff and Vale University Health Board
Eligibility
Sex/Gender
All
Age
16 Years to 110 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 01/04/2026: 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 <30 micromol/L 4.6. ALT/AST =2.5 x ULN (if both done, both must meet criteria) 4.7. Creatinine clearance =50 ml/min (Creatinine clearance should be estimated using the online ClinCalc calculator: https://clincalc.com/kinetics/crcl.aspx) 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. Peritoneal Metastasis (PM) from MDT confirmed primary adenocarcinoma (this may include “suspicious” if agreed by MDT) of the colorectum or appendiceal cancer (not pseudomyxoma). Ovarian group only: 1. PM from MDT 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). (This may include “suspicious” if agreed by MDT). 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]). _____ Previous participant inclusion criteria as of 19/06/2025: 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 <30 micromol/L 4.6. ALT/AST =2.5 x ULN (if both done, both must meet criteria) 4.7. Creatinine clearance =50 ml/min (Creatinine clearance should be estimated using the online ClinCalc calculator: https://clincalc.com/kinetics/crcl.aspx) 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]). _____ Previous participant inclusion criteria as of 20/09/2024: All disease groups: 1. 16 years and older 2. V
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 01/04/2026: 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. Contraindication to any drug contained in the chemotherapy regimen 5. Medical, geographical, sociological, psychological, or legal conditions that would prevent the patient from completing the study or signing the informed consent 6. Unresolved bowel obstruction or parenteral nutrition or gastric tube 7. Contraindication to surgery 8. Participating in other oncological trials that may impact on endpoint 9. Life expectancy 1cm 1.3. Solid organ metastases deemed asymptomatic and non-progressive by MDT 2. Eligible for and chooses cytoreductive surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) upfront 3. Dihydropyrimidine Dehydrogenase Deficiency (DPYD) variant detected 4. Microsatellite instability (MSI) high or MMR-deficient (unless progressed on immunotherapy) 5. Previous cytoreductive surgery (CRS) or Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and felt to be surgically suitable by MDT 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 6. Previous cytoreductive surgery (CRS) or Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and felt to be surgically suitable by MDT. _____ Previous key exclusion criteria as of 28/10/2025: 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. Contraindication to any drug contained in the chemotherapy regimen 5. Medical, geographical, sociological, psychological, or legal conditions that would prevent the patient from completing the study or signing the informed consent 6. Unresolved bowel obstruction or parenteral nutrition or gastric tube 7. Contraindication to surgery 8. Participating in other oncological trials that may impact on endpoint 9. Life expectancy <3 months *Note a minimum of 4 weeks washout between date of PIPAC 1 and last
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peritoneal progression-free survival (pPFS) measured using Response Evaluation Criteria in Solid Tumours (RECIST) V1.1 criteria based on CT scans performed at baseline, prior to each cycle of chemotherapy, prior to each cycle of PIPAC, 30 days after each PIPAC, every two months for the first year after of trial treatment and every three months thereafter until the end of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Oncology patients' core quality of life measures using the EORTC QLQ C30 questionnaire at baseline, after each PIPAC cycle, 2 months follow up, 4 monthly thereafter 2. Safety and surgical complication rates measured using 2.1 and 2.1.1 below prior to and post each PIPAC cycle: 2.1. Toxicity and grade according to NCI Common Terminology Criteria for Adverse Events (CTCAE) V5.0 2.1.1. Episodes of neutropenic sepsis 2.2. Clavien Dindo Classification (within 30 days of each PIPAC) 2.3. Incidence of radiologically proven bowel obstruction every 2 months in the first year then every 3 months 3. Proportion of patients completing 3 PIPAC procedures, and reasons why not if <3 completed 4. Number of conversions to operable disease in the stomach or colorectal cancer 5. OS, defined as days from randomisation to death for any reason 6. PFS. This is defined as the time from the date of randomisation to the date of progression (anywhere in the patient) or death from any cause 6.1. Extraperitoneal PFS (ePFS), defined as the time from the date of randomisation to the date of progression (outside of the peritoneum) or death from any cause 6.2. Episodes of therapeutic ascitic drainages (in ovarian cancer) 7. Peritoneal specific ORR observed at any time during treatment and follow-up 8. Peritoneal-specific DCR, defined as the proportion of patients with complete response, partial response or stable disease maintained at the end of treatment scan (i.e. 3rd scan) | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Outcome results
None listed