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Gastric AdenocarcinomaPhase 2PIPAC EstoK 01NCT04065139

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Carcinomatosis. Phase II Randomized Study

A Phase 2 study testing Pressurized intraperitoneal aerosol chemotherapy (PIPAC) and Standard chemotherapy in people with Gastric Adenocarcinoma and Cancer Metastatic, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Peritoneal metastasis is a common pattern in advanced gastric cancer leading to a terminal condition in a very short time. Whatever recent progress regarding systemic chemotherapy using multi drugs association median survival is limited to 6 months with altered quality of life (QoL) after 4 months for all patients. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) and Standard chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteFrance
Study dates
11 Jun 2020to 2 Mar 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 < age ≤ 75 years
  • Performance status (WHO) < 2
  • White blood cells > 3.500 /mm3; neutrophils > 1.500 /mm3; platelets > 100.000 /mm3
  • Creatinemia < 1.5 x Normal, Normal ASAT, ALAT and Serum total bilirubin, Normal ionic balance (potassium, calcium, magnesium and phosphorus
  • An acceptable nutritional condition with Body Mass Index (BMI) > 18.5 kg/m2, Albumin > 30 g/l, pre-albumin > 110 mg/l
  • Effective contraception for patients of childbearing age
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  • Written consent obtained prior any act of the research
  • Patient with social insurance
  • Patient having synchronous or metachronous peritoneal metastasis or ovarian metastasis of a gastric adenocarcinoma cancer, including adenocarcinoma with independent cells (ADCI) or linitis
  • Patients with or without primary gastric tumor could be included
  • Peritoneal Cancer Index (PCI) > 8

Who cannot join

  • Weight loss > 20% of total body weight before disease
  • Presence of uncontrolled comorbidities including severe chronic disease or organ insufficiency
  • Contraindication to any drug contained in the chemotherapy regimen, according to summary of product characteristic's
  • Having any form of previous intra-abdominal chemotherapy or intra-abdominal antibody therapy
  • Patients with history of allergic reactions to platinum compounds or doxorubicin
  • Complete deficiency of the enzyme dihydropyrimidine dehydrogenase.
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  • Patients are not allowed to undergo any cancer-specific treatment during the trial.
  • Secondary debulking surgery is not allowed during PIPAC treatment
  • Pregnancy or breastfeeding
  • Patient under guardianship
  • Other systemic metastases (liver, lung, bone, brain) or lombo-aortic lymph node involvement
  • Pleural effusion requiring evacuation for respiratory failure
  • Small bowel occlusion with no possible food intake
  • Ascites > 3 liters
  • HER2 +++ tumor

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Universitaire Claude Huriez

    Lille, 59000

Other trials in France

About this study

Official title: Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Carcinomatosis. Phase II Randomized Study - PIPAC EstoK 01

Peritoneal metastasis is a common pattern in advanced gastric cancer leading to a terminal condition in a very short time. Whatever recent progress regarding systemic chemotherapy using multi drugs association median survival is limited to 6 months with altered quality of life (QoL) after 4 months for all patients. We postulated that a new innovative health technology for delivering intraperitoneal pressurized aerosol of chemotherapy (Doxorubicin and Cisplatin) during laparoscopy can transform that situation offering to double the survival with QoL preservation. Interestingly, PIPAC procedure is made to be applied repeatedly, every 4 to 6 weeks. This therapeutic strategy allows to improved Intra Peritoneal (IP) drugs impregnation and maintained Intra-Veinous (IV) chemotherapy meanwhile. The primary objective of this study is to evaluate and compare 24-month progression free-survival in patients with peritoneal carcinomatosis of gastric cancer treated either with IV chemotherapy and Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) or with IV chemotherapy alone, with preservation of quality of life.

Being tested
Pressurized intraperitoneal aerosol chemotherapy (PIPAC), Standard chemotherapy
Keywords
pressurized intraperitoneal aerosol chemotherapy (PIPAC), gastric adenocarcinoma, metastasis
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pressurized intraperitoneal aerosol chemotherapy (PIPAC)Drug

    After insufflation of a 12 mmHg of capnoperitoneum at 37°C, two balloons safety trocars (10 and 12mm) are inserted into the abdominal wall. Injection of Doxorubicin (2.1 mg/m2 in 50 ml NaCl 0.9%) and Cisplatin (10.5 mg/m2 body surface in 150 ml NaCl 0.9%) with a flow rate of 0.7ml/s, the therapeutic capnoperitoneum is maintained for 30 min at body temperature.

  • Standard chemotherapyDrug

    Patient will receive standard poly chemotherapy proposed by the oncologist or any new standard validated during the study, until progression or toxicity.

Study groups in NCT04065139
Study groupRoleWhat they receive
Control ArmActive comparatorNot described
Receives: Drug: Standard chemotherapy
Experimental Arm : PIPACExperimentalNot described
Receives: Drug: Pressurized intraperitoneal aerosol chemotherapy (PIPAC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free survival

    24-month progression free-survival, defined as time from randomization to any clinical (ascites, abdominal pain, weight loss > 10% of total body weight) and/or morphological signs (systemic metastases, ascites, progression with RECIST criteria) of recurrence (local or systemic) or death.

    Measured: 24 months

Secondary outcomes (17)

  1. Postoperative pain H6

    Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)

    Measured: 6 hours after end of surgery

  2. Postoperative pain H12

    Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)

    Measured: 12 hours after end of surgery

  3. Postoperative pain H18

    Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)

    Measured: 18 hours after end of surgery

  4. Postoperative pain H24

    Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)

    Measured: 24 hours after end of surgery

  5. Postoperative pain H30

    Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)

    Measured: 30 hours after end of surgery

  6. Postoperative pain H36

    Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)

    Measured: 36 hours after end of surgery

  7. Postoperative pain H42

    Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)

    Measured: 42 hours after end of surgery

  8. Postoperative pain H48

    Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)

    Measured: 48 hours after end of surgery

  9. Overall survival

    Progression Free survival

    Measured: 24 months

  10. Secondary resectability rate

    Secondary resectability rate after the treatment

    Measured: 24 months

  11. Quality of life

    Quality of life evaluated monthly by the patient with the EORTC QLQ-STO22 questionnaire

    Measured: monthly until death or 24 months

  12. Quality of health status

    Quality of health status evaluated monthly by the patient with the EQ-5D-5L questionnaire

    Measured: monthly until death or 24 months

  13. Toxicity

    Rate of treatment-related toxicity at 60 days of each PIPAC procedure

    Measured: 60 days

  14. PIPAC success

    Rate of successful PIPAC procedures

    Measured: 24 hours

  15. Morbidity Clavien-Dindo

    Morbidity will be evaluated on post-operative day 60 by the Clavien-Dindo classification (I to V)

    Measured: 60 days

  16. Morbidity Complication Index

    Morbidity will be evaluated by the Comprehensive Complication Index, ranging from 0 to 100 (https://www.assessurgery.com/about_cci-calculator)

    Measured: 60 days

  17. Discontinuation

    The time of discontinuation defined as the time from randomization to therapy change or dose reduction because of progression of disease or intolerance or adverse effects or patient refusal or death.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2019
  2. Study start11 Jun 2020
  3. Primary completion2 Mar 2024
  4. Study completion2 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04065139
Sponsor's protocol ID
P160951J
Other IDs
2018-004755-20, 2018
Acronym
PIPAC EstoK 01
Status last verified
Aug 2024
First submitted
21 Aug 2019
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pressurized intraperitoneal aerosol chemotherapy (PIPAC) and Standard chemotherapy in people with Gastric Adenocarcinoma and Cancer Metastatic, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free survival (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04065139.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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