Actively Recruiting
Comparing the Safety and Efficacy of First-line Polychemotherapy and Polychemotherapy in Combination With PIPAC Sessions
Led by Nizhny Novgorod Regional Clinical Oncology Center · Updated on 2025-11-21
106
Participants Needed
1
Research Sites
240 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
After the initial diagnostic laparoscopy the Control group patients undergo 6 courses of polychemotherapy according to the FLOT scheme; the examination is carried out every 3 courses (after the 3rd and the 6th courses) with the control diagnostic laparoscopy after 6 courses of polychemotherapy. In the event of the complete regression of foci along the peritoneum and receiving Cy- in the peritoneal lavage, the dynamic observation or cytoreductive surgery is considered (optionally); in case of the incomplete response the dynamic observation is carried out until progression; in case of progression the 2nd line of chemotherapy or the optimal palliative care options depending on the clinical situation is considered. After the initial diagnostic laparoscopy the Study group patients undergo courses of polychemotherapy according to the scheme FLOT (the 1st, the 3rd, the 5th courses) and mFLOT (the 2nd , the 4th, the 6th courses) in the amount of 6 (six, 3+3); the examination is carried out every 3 courses (after the 3rd and the 6th courses) with dPIPAC sessions using docetaxel (thus excluding it from the system administration) in the 2nd , the 4th, the 6th courses of polychemotherapy. Control diagnostic laparoscopy is not performed in the group No 2, its function is performed by the revision at the PIPAC session of the 6th course of polychemotherapy, which corresponds to the time interval of the Control group. In the event of the complete regression of foci along the peritoneum and receiving Cy- in the peritoneal lavage, the dynamic observation or cytoreductive surgery is considered (optionally); in case of the incomplete response the dynamic observation is carried out until progression; in case of progression the 2nd line of chemotherapy or the optimal palliative care options depending on the clinical situation is considered.
CONDITIONS
Official Title
Comparing the Safety and Efficacy of First-line Polychemotherapy and Polychemotherapy in Combination With PIPAC Sessions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent to participate in the study
- Age between 18 and 75 years
- ECOG performance status 0 or 1
- Histological confirmation of gastric cancer or esophageal-gastric junction Siewert III adenocarcinoma or ring-cell carcinoma
- Tumor is Her2-neu negative
- Presence of a preserved informative block of the primary tumor in the histological archive
- Verified gastric cancer with M1 limited to positive peritoneal cytology (Cy+) and/or peritoneal dissemination with PCI less than 16
- Peritoneal adhesion index (PAI) less than 16
- No active infectious, mental diseases, pronounced allergic conditions, or other significant health problems that could affect treatment
- Adequate organ function based on laboratory tests
- Agreement to use effective contraception if of childbearing potential
You will not qualify if you...
- No signed informed consent
- Age under 18 or over 75 years
- ECOG performance status 2 or higher
- Histological types other than adenocarcinoma or ring-cell carcinoma of the stomach or esophageal-gastric junction Siewert III
- Tumor is Her2-neu positive
- Absence of preserved informative tumor block in the histological archive
- Presence of distant metastases other than positive peritoneal cytology or peritoneal dissemination PCI 16 or higher
- Peritoneal adhesion index (PAI) of 16 or higher
- Contraindications to diagnostic laparoscopy
- Complicated primary tumor such as bleeding or severe stenosis not corrected
- Decompensated concomitant diseases
- Multiple primary tumors except specific skin or cervical cancers without relapse
- Previous cancer treatments for stomach or other malignant tumors except specified exceptions
- Known intolerance to study drugs
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncological Dispensary", 11/1, Delovaya street, Nizhny Novgorod, 603126
Nizhny Novgorod, Russia, 603126
Actively Recruiting
Research Team
S
Sergey Klimin
CONTACT
N
Nikolai Kiselev
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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