- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04595929
Oncological Benefits of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) in Patients With T3-4 Gastric Cancer Cyt- (GASPACCO)
Single-center Randomized Study Evaluating of Oncological Benifits of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) in Patients With Locally Advanced Gastric Cancer in Patients With Cyt-.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alexander Zakharenko, PhD
- Phone Number: +7 9219516183
- Email: 9516183@mail.ru
Study Contact Backup
- Name: Michael Belyaev, PhD
- Phone Number: +7 89218628926
- Email: 8628926@mail.ru
Study Locations
-
-
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Saint-Petersburg, Russian Federation, 197101
- Recruiting
- First Pavlov State Medical University of St. Petersburg
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Contact:
- Ilya Vervekin
- Phone Number: 89119695285
- Email: iivervekin@yandex.ru
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Sub-Investigator:
- Michael Belyaev, PhD
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Principal Investigator:
- Alexander Zakharenko, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically confirmed, medically operable, resectable stomach adenocarcinoma (cT3-4, any N category, M0).
- No preceding cytotoxic or targeted therapy.
- No prior partial or complete tumor resection.
Female and male patient ≥ 18 and ≤ 75 years. Female patient with childbearing potential needs to have a negative pregnancy test within 7 days prior to study start. Males and females of reproductive potential must agree to practice highly effective contraceptive measures* during the study. Male patients must also agree to refrain from father a child during treatment and additionally to use a condom during treatment period. Their female partner of childbearing potential must also agree to use an adequate contraceptive measure.
*highly effective (i.e. failure rate of <1% per year when used consistently and correctly) methods: intravaginal and transdermal combined (estrogen and progestogen containing) hormonal contraception; injectable and implantable progestogen-only hormonal contraception; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence (complete abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments).
- ECOG = 0-2.
- Exclusion of distant metastases by CT or MRI of abdomen, pelvis, and thorax, bone scan or MRI (if bone metastases are suspected due to clinical signs). Exclusion of the infiltration of any adjacent organs or structures by CT or MRI.
- Laparoscopic exclusion of peritoneal carcinomatosis at initial staging, before start of FLOT chemotherapy
- Adequate hematological, hepatic and renal function parameters:
Leukocytes ≥ 3000/mm³, platelets ≥ 100,000/mm³, neutrophil count (ANC) ≥1000/µL Serum creatinine ≤ 1.5 x upper limit of normal Bilirubin ≤ 1.5 x upper limit of normal, AST and ALT ≤ 3.0 x upper limit of normal, alkaline phosphatase ≤ 6 x upper limit of normal For patients not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 x ULN; for patients receiving therapeutic anticoagulation: stable anticoagulant regimen.
- Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures.
Exclusion Criteria:
- Patient without neoadjuvant therapy or those who received a neoadjuvant therapy other than FLOT.
- Known hypersensitivity against 5-FU, leucovorin, oxaliplatin, or docetaxel.
- Other known contraindications against, 5-FU, leucovorin, oxaliplatin, or docetaxel.
- Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV.
- Clinically significant valvular defect.
- Criteria of primary unresectability, e.g.:
Radiologically documented evidence of major blood vessel invasion or invasion of adjacent organs (T4b).
Patients with involved retroperitoneal (e.g. para-aortal, paracaval or interaortocaval lymph nodes) or mesenterial lymph nodes (distant metastases!).
- Other severe internal disease or acute infection.
- Peripheral polyneuropathy ≥ NCI Grade II.
- Patient has undergone major surgery within 28 days prior to enrollment except staging laparoscopy.
- Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or ascites.
- On-treatment participation in another interventional clinical study in the period 30 days prior to inclusion and during the study.
- Patient pregnant or breast feeding, or planning to become pregnant.
- Any other concurrent antineoplastic treatment including irradiation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PIPAC group
|
Day 1 q2w: 2600 mg/m² IV over 24 hours
Other Names:
Day 1 q2w: 200 mg/m² IV over 30 minutes
Other Names:
Day 1 q2w: 85 mg/m² IV over 2 hours
Day 1 q2w: 50 mg/m² IV over 1 hour
All patients undergo staging laparoscopy and peritoneal lavage.
Radical gastrectomy with D2 - lymph node dissection.
Intraoperative Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) with cisplatin 7,5 mg/m², doxorubicin 1,5 mg/m².
Adjuvant chemotherapy according to indications.
|
Active Comparator: Control group
|
Day 1 q2w: 2600 mg/m² IV over 24 hours
Other Names:
Day 1 q2w: 200 mg/m² IV over 30 minutes
Other Names:
Day 1 q2w: 85 mg/m² IV over 2 hours
Day 1 q2w: 50 mg/m² IV over 1 hour
All patients undergo staging laparoscopy and peritoneal lavage.
Radical gastrectomy with D2 - lymph node dissection.
Adjuvant chemotherapy according to indications.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of Overall survival (OS) in both arms
Time Frame: from randomization up to 5 years
|
Overall survival (OS) where OS is defined as the time from randomization to death from any cause.
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from randomization up to 5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS/DFS rates at 2, 3 & 5 years
Time Frame: 2, 3 & 5 years after randomization
|
PFS/DFS rates at 2, 3 & 5 years defined as the percentage of patients without disease progression or relapse after surgery or death from any cause after 2, 3 and 5 years referring to the total number of patients randomized into the respective treatment arm
|
2, 3 & 5 years after randomization
|
Rate of surgical serious adverse events (SAEs)
Time Frame: After randomization of the patient until 30 days after last study-specific treatment
|
Rate of surgical serious adverse events, according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0) grade ≥ 3 adverse events and grade ≥ 3 laboratory toxicities.
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After randomization of the patient until 30 days after last study-specific treatment
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Patient reported outcomes: Quality of life EORTC QLQ C30 questionnaire
Time Frame: From date of screening until the date of first documented progression or last visit before date of death from any cause, whichever came first, assessed 8 weeks +/- 7 days until EOT, afterwards every 3 months up to 2 years after last patient in
|
The QoL analyses will include QoL mean values, QoL response and time to symptom deterioration (TTSD) defined as the time interval between randomization and the first decrease by ≥ 10-points. All randomly assigned patients with a baseline and at least one post-baseline assessment will be included in TTSD analyses. Patients without observed deterioration will be censored at the time of their last QoL assessment. Questionnaires given to the patients (validated quality of life questionnaires EORTC QLQ C30). EORTC QLQ C30 contains 30 questions: 28 questions regarding body fitness, daily routines, restrictions at work and hobby, appetite, fatigue, cough, breathlessness, pain, tiredness, and body conditions from (1) to (4); 1 (not a bit), 2 (little), 3 (moderate), 4 (much). 2 questions regarding state of health and Quality of life with a horizontal rating from 1 to 7; 1 (very bad), 7 (excellent). |
From date of screening until the date of first documented progression or last visit before date of death from any cause, whichever came first, assessed 8 weeks +/- 7 days until EOT, afterwards every 3 months up to 2 years after last patient in
|
Patient reported outcomes: VAS pain assessment form
Time Frame: From date of screening until the date of first documented progression or last visit before date of death from any cause, whichever came first, assessed 8 weeks +/- 7 days until EOT, afterwards every 3 months up to 2 years after last patient in
|
The patient´s assessment of their current level of pain on a 100-mm horizontal VAS.
The left-hand extreme of the line should be described as "no pain" and the right-hand as "unbearable pain".
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From date of screening until the date of first documented progression or last visit before date of death from any cause, whichever came first, assessed 8 weeks +/- 7 days until EOT, afterwards every 3 months up to 2 years after last patient in
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Rate of post-operative morbidity/mortality at day 30 after surgery acc. to Clavien-Dindo classification
Time Frame: at day 30 after surgery
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Rate of post-operative morbidity/mortality will be assessed at day 30 after surgery acc. to Clavien-Dindo classification.
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at day 30 after surgery
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Comparison of Overall survival rates at 3 and 5 years in both arms
Time Frame: 3 and 5 years after randomization
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Overall survival rates at 3 & 5 years defined as the percentage patients known to be alive after 3 and 5 years referring to the total number of patients randomized into the respective treatment arm
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3 and 5 years after randomization
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Comparison of progression-/disease-free survival (PFS/DFS) between arms
Time Frame: from randomization up to 5 years
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PFS/DFS is defined as the time from randomization to disease progression or relapse after surgery or death from any cause.
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from randomization up to 5 years
|
Comparison of peritoneal relapse rate in both arms
Time Frame: from randomization up to 5 years
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Peritoneal relapse rate defined as the percentage of patients with peritoneal relapse referring to the total number of patients randomized into the respective treatment arm
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from randomization up to 5 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Alexander Zakharenko, PhD, First Pavlov State Medical University of St. Petersburg
- Study Chair: Ilya Vervekin, First Pavlov State Medical University of St. Petersburg
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Peritoneal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Abdominal Neoplasms
- Stomach Neoplasms
- Carcinoma
- Peritoneal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Protective Agents
- Micronutrients
- Vitamins
- Antidotes
- Vitamin B Complex
- Docetaxel
- Fluorouracil
- Oxaliplatin
- Leucovorin
Other Study ID Numbers
- 1-AbOn-2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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