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Compares treatment options for Gastric Cancer
Official title Comparing the Safety and Efficacy of First-line Polychemotherapy and Polychemotherapy in Combination With PIPAC Sessions
ClinicalTrials.gov ID: NCT06313801
What this study is testing
What is Docetaxel?
Docetaxel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastric cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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
You likely can't join if
- Lack of informed voluntary consent of the patient
- Age \ 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
See the full eligibility criteria
- 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...
- 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.
- Lack of informed voluntary consent of the patient
- Age \ 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Nizhny Novgorod, Russia
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nizhny Novgorod, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.