Comparing the Safety and Efficacy of First-line Polychemotherapy and Polychemotherapy in Combination With PIPAC Sessions
The Single-center Randomized Study "Comparison of Safety and Effectiveness of the First Line of Polychemotherapy and Polychemotherapy in Combination With PIPAC Sessions in Primary Gastric Cancer With Isolated Peritoneal Carcinomatosis.
Nizhny Novgorod Regional Clinical Oncology Center
106 participants
Jan 19, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria11
- 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.
Exclusion Criteria16
- 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
- Pregnancy, breast-feeding
Interventions
Docetaxel 50 mg/m2 intravenously on day 1
Oxaliplatin 85 mg/m2 on Day 1
200 mg/m2 2-hour intravenous infusion on day 1
2600 mg/m2 x intravenous infusion 24-hours (infusion of the samee of the total dose of fluorouracil for 48 hours) on day 1.
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06313801