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PIPAC for Peritoneal Metastases

Primary Purpose

Peritoneal Metastases

Status
Recruiting
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
PIPAC
Sponsored by
National Cancer Centre, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peritoneal Metastases

Eligibility Criteria

21 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

For Unesectable PM Group:

  • Age ≥ 21 years old
  • ECOG < 3
  • Fit for systemic chemotherapy treatment
  • Adequate bone marrow function (haemoglobin ≥ 8.0 mmol/L, neutrophils ≥ 1.5X109/L, platelets ≥ 100X109/L
  • Adequate renal function (e-GFR > 30mls/min for patients undergoing PIPAC with oxaliplatin; e-GFR > 60mls/min for patients undergoing PIPAC with Doxorubicine/Cisplatin)
  • Adequate liver function (Total bilirubin < 1.5 upper limit of normal; ALT and AST< 3 upper limit of normal)
  • No contraindications to chemotherapy agents oxaliplatin, doxorubicin/ cisplatin
  • No contraindications to general anaesthesia and diagnostic laproscopy procedure
  • Normal left ventricular ejection fraction (for patients undergoing PIPAC with doxorubicin/ cisplatin)
  • Histological/ cytological proof of PM from GI, HPB, Gynaecology, Breast, Sarcoma primaries
  • Peritoneal-dominant metastatic disease

For the Extensive PM Group:

All the above mentioned criteria as for the unresectable group, with the addition of the following:

  • Not suitable for curative cytoreductive surgery (CRS) & hyperthermic intraperitoneal chemotherapy (HIPEC) surgery after diagnostic laproscopy - PCI > 18 in LGI, PCI > 6 in UGI ECOG < 3
  • In UGI PM patients, progression while on bidirectional chemotherapy

Exclusion Criteria:

  • Patient is medically unfit for surgery due to concurrent medical comorbidities, including but not limited to intestinal obstruction, multiple sites of metastases
  • Any medical or psychiatric condition(s) which would preclude informed consent
  • Patient is pregnant or nursing
  • GI PM patients with PCI >6 but are treatment naive (these patients should undergo standard treatment - bidirectional intravenous and intraperitoneal chemotherapy)

Sites / Locations

  • National Cancer Center SingaporeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Unresectable PM group

Extensive PM group

Arm Description

Patients who have progressed on conventional systemic therapy and PIPAC is used as a palliative strategy.

Patients who have significant volume of peritoneal disease are treated with the intent for potential conversion to curative surgery. Role of PIPAC is as an adjunct to systemic chemotherapy to downstage peritoneal metastases.

Outcomes

Primary Outcome Measures

Number of patients with major toxicities of at least CTCAE Grade 3 and above
To determine and safety and feasibility of PIPAC in patients with PM. Common Terminology Criteria for Adverse Events (CTCAE) measures Grade 1 to 5, with higher grade indicating greater severity.
Number of patients with minor toxicities of CTCAE Grade 1 and 2
Common Terminology Criteria for Adverse Events (CTCAE) measures Grade 1 to 5, with higher grade indicating greater severity.
Length of hospitalisation stay for each PIPAC procedure

Secondary Outcome Measures

Intra-operative Peritoneal Carcinomatosis Index (PCI) score
To examine the clinical response of PM after PIPAC. PCI score from 0 to 39 with a higher number representing a greater amount of disease present in the peritoneum.
Ascites volume
To examine the clinical response of PM after PIPAC
Peritoneal Regression Grading Score (PRGS) from PM biopsy
To examine the clinical response of PM after PIPAC
Quality of Life Assessment using Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire
Range: 0-108. A high score represents a better health state
Quality of Life Assessment using European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Quality of life questionnaire
Range: 0-100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
Progression free survival
Overall survival
Percentage of patients that convert to curative surgery
(Only applicable for Extensive PM group)

Full Information

First Posted
May 24, 2021
Last Updated
December 19, 2021
Sponsor
National Cancer Centre, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT04956068
Brief Title
PIPAC for Peritoneal Metastases
Official Title
Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Centre, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel drug delivery system that allows the direct application of chemotherapeutic agents into the peritoneal cavity. It boosts improved distribution, enhanced tissue uptake and repeatability using minimally invasive access. It was devised to palliate the local symptoms of extensive peritoneal metastases (PM) in patients who are not amenable to curative surgery. This study is to determine safety and feasibility of PIPAC in patients with PM from Gastrointestinal (GI) cancer, Hepato-Pancreato-Biliary (HPB) cancer, and other rare malignancies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Unresectable PM group
Arm Type
Experimental
Arm Description
Patients who have progressed on conventional systemic therapy and PIPAC is used as a palliative strategy.
Arm Title
Extensive PM group
Arm Type
Experimental
Arm Description
Patients who have significant volume of peritoneal disease are treated with the intent for potential conversion to curative surgery. Role of PIPAC is as an adjunct to systemic chemotherapy to downstage peritoneal metastases.
Intervention Type
Combination Product
Intervention Name(s)
PIPAC
Intervention Description
A novel drug delivery system using the CapnoPen device which allows the aerolisation of chemotherapeutic agents within the peritoneal cavity. PIPAC procedure will be carried out with either oxaliplatin or doxorubicin/ cisplatin.
Primary Outcome Measure Information:
Title
Number of patients with major toxicities of at least CTCAE Grade 3 and above
Description
To determine and safety and feasibility of PIPAC in patients with PM. Common Terminology Criteria for Adverse Events (CTCAE) measures Grade 1 to 5, with higher grade indicating greater severity.
Time Frame
Up to 4 weeks after each PIPAC procedure
Title
Number of patients with minor toxicities of CTCAE Grade 1 and 2
Description
Common Terminology Criteria for Adverse Events (CTCAE) measures Grade 1 to 5, with higher grade indicating greater severity.
Time Frame
Up to 4 weeks after each PIPAC procedure
Title
Length of hospitalisation stay for each PIPAC procedure
Time Frame
Through study completion, an average of half a year
Secondary Outcome Measure Information:
Title
Intra-operative Peritoneal Carcinomatosis Index (PCI) score
Description
To examine the clinical response of PM after PIPAC. PCI score from 0 to 39 with a higher number representing a greater amount of disease present in the peritoneum.
Time Frame
During each PIPAC procedure
Title
Ascites volume
Description
To examine the clinical response of PM after PIPAC
Time Frame
During each PIPAC procedure
Title
Peritoneal Regression Grading Score (PRGS) from PM biopsy
Description
To examine the clinical response of PM after PIPAC
Time Frame
At each PIPAC procedure
Title
Quality of Life Assessment using Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire
Description
Range: 0-108. A high score represents a better health state
Time Frame
At 4 time points - Baseline (before any PIPAC procedure), pre-2nd PIPAC (Before 2nd PIPAC procedure), pre-3rd PIPAC (before 3rd PIPAC procedure) and 4 weeks post-3rd PIPAC (4 weeks after 3rd PIPAC procedure)
Title
Quality of Life Assessment using European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Quality of life questionnaire
Description
Range: 0-100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
Time Frame
At 4 time points - Baseline (before any PIPAC procedure), pre-2nd PIPAC (Before 2nd PIPAC procedure), pre-3rd PIPAC (before 3rd PIPAC procedure) and 4 weeks post-3rd PIPAC (4 weeks after 3rd PIPAC procedure)
Title
Progression free survival
Time Frame
From the start of the first PIPAC procedure, up to 5 years
Title
Overall survival
Time Frame
From the start of the first PIPAC procedure, up to 5 years
Title
Percentage of patients that convert to curative surgery
Description
(Only applicable for Extensive PM group)
Time Frame
From the start of the first PIPAC procedure, up to 24 weeks ± 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: For Unesectable PM Group: Age ≥ 21 years old ECOG < 3 Fit for systemic chemotherapy treatment Adequate bone marrow function (haemoglobin ≥ 8.0 mmol/L, neutrophils ≥ 1.5X109/L, platelets ≥ 100X109/L Adequate renal function (e-GFR > 30mls/min for patients undergoing PIPAC with oxaliplatin; e-GFR > 60mls/min for patients undergoing PIPAC with Doxorubicine/Cisplatin) Adequate liver function (Total bilirubin < 1.5 upper limit of normal; ALT and AST< 3 upper limit of normal) No contraindications to chemotherapy agents oxaliplatin, doxorubicin/ cisplatin No contraindications to general anaesthesia and diagnostic laproscopy procedure Normal left ventricular ejection fraction (for patients undergoing PIPAC with doxorubicin/ cisplatin) Histological/ cytological proof of PM from GI, HPB, Gynaecology, Breast, Sarcoma primaries Peritoneal-dominant metastatic disease For the Extensive PM Group: All the above mentioned criteria as for the unresectable group, with the addition of the following: Not suitable for curative cytoreductive surgery (CRS) & hyperthermic intraperitoneal chemotherapy (HIPEC) surgery after diagnostic laproscopy - PCI > 18 in LGI, PCI > 6 in UGI ECOG < 3 In UGI PM patients, progression while on bidirectional chemotherapy Exclusion Criteria: Patient is medically unfit for surgery due to concurrent medical comorbidities, including but not limited to intestinal obstruction, multiple sites of metastases Any medical or psychiatric condition(s) which would preclude informed consent Patient is pregnant or nursing GI PM patients with PCI >6 but are treatment naive (these patients should undergo standard treatment - bidirectional intravenous and intraperitoneal chemotherapy)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claramae Chia, MBBS
Phone
+65 6436 8000
Email
claramae.chia.s.l@singhealth.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claramae Chia, MBBS
Organizational Affiliation
National Cancer Centre, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center Singapore
City
Singapore
ZIP/Postal Code
169690
Country
Singapore
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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PIPAC for Peritoneal Metastases

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