Comparing the Safety and Efficacy of First-line Polychemotherapy and Polychemotherapy in Combination With PIPAC Sessions

NCT06313801 | Recruiting Phase 2

• 1 other identifier: DPNCD-2309
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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

Gastric Cancer

Keywords

FLOT; mFLOT; dPIPAC; PIPAC

Outcome Measures

Primary Outcomes (2)

• The progression-free survival.

  Time interval from randomization to progression of disease, death from any cause or date of last observation in the absence of these events. In months with an accuracy of 0.1. (Time Frame: 4 years 6 months)

  4 years 6 months

• Complications from polychemotherapy.

  Complications from polychemotherapy (including intraperitoneal administration), evaluated according to СТСАЕ v5.0. The proportion of patients with any adverse events; the proportion of patients with grade 3-5 adverse events; the proportion of patients with complications in qualitative terms (for example: hematological, gastrointestinal, etc.). (Time Frame: 3 years 6 months)

  3 years 6 months

Secondary Outcomes (5)

• The overall survival.

  4 years 6 months

• The completeness of the planned therapy.

  3 years 6 months

• Percentage of patient conversions to Су- and PCI- rate.

  3 years 6 months

• Surgical complications of operated patients

  3 years 6 months

• Аssessment of the quality of life

  4 years

Study Arms (2)

Control group

ACTIVE COMPARATOR

FLOT: Docetaxel 50 mg/m2 intravenously on day 1 + Oxaliplatin 85 mg/m2 intravenously on day 1 + Calcium folinate 200 mg/m2 2-hour intravenous infusion on day 1 + fluorouracil 2600 mg/m2 x intravenous infusion 24-hours (infusion of the same of the total dose of fluorouracil for 48 hours) on day 1. Repeat every 2 weeks. 6 courses.

Drug: Docetaxel; Drug: Oxaliplatin; Drug: Calcium folinate; Drug: Fluorouracil; Procedure: Diagnostic laparoscopy

Study group

EXPERIMENTAL

mFLOT: Oxaliplatin 85 mg/m2 intravenously on day 1 + Calcium folinate 200 mg/m2 2-hour intravenous infusion on day 1 + fluorouracil 2600 mg/m2 x intravenous infusion 24-hours (infusion of the same of the total dose of fluorouracil for 48 hours) on day 1. Repeat every 2 weeks. 6 courses. \+ The drugs for PIPAC - Docetaxel 50 mg/ m2 diluted with saline sodium chloride to a total volume of 200 ml (intraperitoneal pressurized infusion).

Drug: Oxaliplatin; Drug: Calcium folinate; Drug: Fluorouracil; Procedure: Diagnostic laparoscopy; Combination Product: dPIPAC ( The description of the standard diagnostic laparoscopy procedure and the session of PIPAC (dPIPAC)).

Interventions

Docetaxel DRUG

Docetaxel 50 mg/m2 intravenously on day 1

Control group

Oxaliplatin DRUG

Oxaliplatin 85 mg/m2 on Day 1

Control group; Study group

Calcium folinate DRUG

200 mg/m2 2-hour intravenous infusion on day 1

Control group; Study group

Fluorouracil DRUG

2600 mg/m2 x intravenous infusion 24-hours (infusion of the samee of the total dose of fluorouracil for 48 hours) on day 1.

Control group; Study group

Diagnostic laparoscopy PROCEDURE

Access to the abdominal cavity by Hassen (3 trocars). Carboxyperitoneum - 12 mm of water column - stable pressure maintenance throughout the operation. Revision. Photo recording of 4 quadrants of the abdominal cavity from the paraumbilical port. The evaluation of the PCI index. The evaluation of other distant dissemination. Standard peritoneal lavage of 300 ml Sol. NaCl 0.9 % (37 ºС), with the exposure of 3-5 minutes (with Trendelenburg and Fowler position alternately) and the lavage aspiration, the transfer of the lavage for the cytological examination. Biopsy of perioneal lessions if needed.The operation is completed as standard with the extraction of laparoports and suturing of laparoport wounds.

Control group; Study group

dPIPAC ( The description of the standard diagnostic laparoscopy procedure and the session of PIPAC (dPIPAC)). COMBINATION_PRODUCT

Diagnostic laparoscopy described earlier and PIPAC session. The drugs for PIPAC - Docetaxel 50 mg/ m2 diluted with saline sodium chloride to a total volume of 200 ml. The rate of administration is 30 ml per minute. The maximum pressure in the injector system is 250 PSI. After the spray stage, the exposure is 30 minutes while maintaining the declared intraperitoneal pressure. After the exposure stage, only gas is removed from the abdominal cavity. The operation is completed as standard with the extraction of laparoports and suturing of laparoport wounds.

Study group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Availability of signed informed voluntary consent of the patient
• Age ≥18 years and ≤75 years
• ECOG ≤1
• Histological verification of gastric cancer and esophageal-gastric junction Siewert III (adenocarcinoma, ring-cell carcinoma)
• Her2-neu negative tumor status
• The presence of a preserved informative block of the primary tumor in the histological archive of the NOCOD (performing a biopsy and/or providing archival material - with the consent of the patient)
• Verified gastric cancer (adenocarcinoma, ring-cell carcinoma) with the presence of M1 (with the only manifestation of M1 in the form of - Cy+ in initial peritoneal lavage and/or peritoneal dissemination PCI \<16)
• Peritoneal adhesion index PAI \<16
• Absence of active infectious, mental diseases, pronounced allergic conditions, as well as other concomitant pathology that may interfere with the implementation of the therapeutic and diagnostic measures provided for in the protocol
• Adequate organ function (evaluation by laboratory parameters at screening - evaluation of hemoglobin, neutrophils, platelets, AST, ALT, total bilirubin, urea, creatinine)
• Consent of men and women with preserved childbearing potential to use highly effective methods of contraception.

You may not qualify if:

• Lack of informed voluntary consent of the patient
• Age \<18 years and \>75 years
• ECOG ≥2
• Histological forms other than adenocarcinoma and ring-cell carcinoma of the stomach and esophageal-gastric junction Siewert III
• Her2-neu positive tumor status
• The absence of a preserved informative block of the primary tumor in the histological archive of the NOCOD
• M1 with the exception of Cy+ in initial peritoneal lavage and/or peritoneal dissemination PCI \<16 (Distant metastases, including mts in supraclavicular, mediastinal, paraaortic (16 collector), ovarian metastases. Note - MTS in peripheral lymph nodes require a fine needle puncture with cytological examination for verification. In case of mts lesions of intracorporeal lymph nodes, the criteria of mts will be - dimensions of more than 15 mm along the short axis or mts-altered structure of the lymph node, regardless of size; PCI ≥16)
• Peritoneal adhesion index PAI ≥16
• Contraindications to performing diagnostic laparoscopy
• Complicated primary tumor (bleeding, decompensated stenosis, dysphagia III-IV) if not corrected.
• Decompensated concomitant pathology
• Primary multiple tumors (except basal cell skin cancer and cervical cancer in situ - provided there are no signs of relapse of the disease)
• Any specific antitumor treatment for stomach cancer and /or other malignant tumor in the anamnesis (except basal cell skin cancer and cervical cancer in situ - provided there are no signs of relapse of the disease)
• Previous specialized treatment for stomach cancer
• Known individual intolerance to drugs included in the protocol

Sponsors & Collaborators

• Nizhny Novgorod Regional Clinical Oncology Center: lead

Study Sites (1)

Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncological Dispensary", 11/1, Delovaya street, Nizhny Novgorod, 603126

Nizhny Novgorod, 603126, Russia

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Docetaxel; Oxaliplatin; Leucovorin; Fluorouracil; Laparoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Sergey Gamayunov, DMS

  Chief oncology specialist in the region

  STUDY DIRECTOR

Central Study Contacts

Sergey Klimin

CONTACT

+79875403280; kliminsergey7@gmail.com

Nikolai Kiselev

CONTACT

+79101473722; mdkiselevnm@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: In the control group, after diagnostic laparoscopy, 6 courses of PCT FLOT are carried out, examination every 3 courses with the performance of control diagnostic laparoscopy after 6 courses of PCT. In the study group, after diagnostic laparoscopy, FLOT PCT courses (1st, 3rd, 5th courses), mFLOT (2nd, 4th, 6th courses) are conducted, examination every 3 courses with dPIPAC sessions with docetaxel (excluding it from systemic administration) on the 2nd, 4th, 6th courses of PCT. In group 2, the function of control laparoscopy is performed by revision at the dPIPAC session of the 6th course of PCT. In both groups, with complete regression of foci along the peritoneum and Cy- in peritoneal lavage - dynamic observation or cytoreductive surgery, with incomplete response - dynamic observation before progression, with progression - the 2nd line of CT or optimal palliative care options.

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: March 15, 2024
• Study Start: January 19, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)