Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06313801
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-11-15
Brief Title:
Comparing the Safety and Efficacy of First-line Polychemotherapy and Polychemotherapy in Combination With PIPAC Sessions
Sponsor:
Nizhny Novgorod Regional Clinical Oncology Center
Organization:
Nizhny Novgorod Regional Clinical Oncology Center
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 33 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
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 33 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
Detailed Description:
Signing the informed consent to participate in the study All the patients with suspected peritoneal carcinomatosis according to the results of radiation diagnostics as well as confirmed peritoneal carcinomatosis by puncture biopsy or by taking ascitic fluid undergo diagnostic laparoscopy at the first stage In addition screening will include all the patients with locally advanced gastric cancer undergoing laparoscopy prior to planning combination treatment If they have foci of carcinomatosis in the peritoneum PCI up to 15 inclusive andor Cy as the only manifestation of M1 the patients of this group can be included in the study The methodology for performing diagnostic laparoscopy is described below excluding dPIPAC components Note - the examination of the omental bursa as part of diagnostic laparoscopy is optional depending on the clinical situation Screening and examination of patients according to current clinical guidelines for nosology stomach cancer taking into account the examination criteria specified in this protocol Performing initial diagnostic laparoscopy at the stationary stage according to the standard procedure described above If carcinomatosis is detected the evaluation of PCI is carried out by Sugarbaker The patient randomization based on positive Cy abdominal flushing andor peritoneal dissemination with PCI index 16 The randomization will be carried out using an Internet resource httpswwwsealedenvelopecom Taking into account the planned set and heterogeneity of the groups the patients will be stratified before randomization according to the following factors microscopic carcinomatosis of Cy only macroscopic carcinomatosis PCI up to 7 inclusive macroscopic carcinomatosis PCI from 8 to 15 inclusive accordingly the patients within the strata will be randomized separately
The Control group the group No 1 Within 1-4 weeks after the initial diagnostic laparoscopy the group No 1 patients start polychemotherapy courses according to the FLOT scheme in the amount of 6 six 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 for no more than 2 weeks with no obvious signs of progression in this case the patient switches to the 2nd line of chemotherapy The evaluation of the therapeutic pathomorphosis of foci in the peritoneum is carried out according to the PRGS system Peritoneal Regression Grading Score As the result of the treatment in the event of the complete regression of foci along the peritoneum and receiving Cy- in the peritoneal lavage after the completion of the planned treatment the patients switch to the dynamic observation or cytoreductive surgery is considered within 1 month after the completion of polychemotherapy optionally by decision of the local council in case of the incomplete response due to the immeasurable characteristics of the tumor and the impossibility of evaluation by RECIST the dynamic observation is carried out until progression in case of progression the 2nd line of chemotherapy the scheme at the discretion of the attending physician or the optimal palliative care options depending on the clinical situation is considered accordingly the patient completes the therapy proposed by the study The response criteria are specified separately Shifting the timing of chemotherapy up to 10 days and the timing of control examinations up to 10 days due to objective circumstances is considered acceptable within the study
The Study group the group No 2 Within 1-4 weeks after the initial diagnostic laparoscopy the group No 2 patients start polychemotherapy courses 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 33 the examination is carried out every 3 courses after the 3rd and the 6th courses with with dPIPAC sessions using docetaxel the examination is carried out every 3 courses after the 3rd and 6th with the performance of dPIPAC sessions using docetaxel thus excluding it from the system administration in the 2nd the 4th the 6th courses of polychemotherapy all the procedures are performed according to the method described in the protocol the evaluation of the therapeutic pathomorphosis of lesions in the peritoneum is carried out according to the PRGS system Peritoneal Regression Grading Score 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 group No 1 As the result of the treatment in the event of the complete regression of foci along the peritoneum and receiving Cy- in the peritoneal lavage after the completion of the planned treatment the patients switch to the dynamic observation or cytoreductive surgery is considered after the completion of polychemotherapy optionally by decision of the local council in case of the incomplete response due to the immeasurable characteristics of the tumor and the impossibility of evaluation by RECIST the dynamic observation is carried out until progression in case of progression the 2nd line of chemotherapy the scheme at the discretion of the attending physician or the optimal palliative care options depending on the clinical situation is considered accordingly the patient completes the therapy proposed by the study The method of performing the surgical manual is specified separately The response criteria are specified separately Shifting the timing of chemotherapy with dPIPAC sessions up to 10 days and the timing of control examinations up to 10 days due to objective circumstances is considered acceptable within the study
The Control group the group No 1 Within 1-4 weeks after the initial diagnostic laparoscopy the group No 1 patients start polychemotherapy courses according to the FLOT scheme in the amount of 6 six 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 for no more than 2 weeks with no obvious signs of progression in this case the patient switches to the 2nd line of chemotherapy The evaluation of the therapeutic pathomorphosis of foci in the peritoneum is carried out according to the PRGS system Peritoneal Regression Grading Score As the result of the treatment in the event of the complete regression of foci along the peritoneum and receiving Cy- in the peritoneal lavage after the completion of the planned treatment the patients switch to the dynamic observation or cytoreductive surgery is considered within 1 month after the completion of polychemotherapy optionally by decision of the local council in case of the incomplete response due to the immeasurable characteristics of the tumor and the impossibility of evaluation by RECIST the dynamic observation is carried out until progression in case of progression the 2nd line of chemotherapy the scheme at the discretion of the attending physician or the optimal palliative care options depending on the clinical situation is considered accordingly the patient completes the therapy proposed by the study The response criteria are specified separately Shifting the timing of chemotherapy up to 10 days and the timing of control examinations up to 10 days due to objective circumstances is considered acceptable within the study
The Study group the group No 2 Within 1-4 weeks after the initial diagnostic laparoscopy the group No 2 patients start polychemotherapy courses 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 33 the examination is carried out every 3 courses after the 3rd and the 6th courses with with dPIPAC sessions using docetaxel the examination is carried out every 3 courses after the 3rd and 6th with the performance of dPIPAC sessions using docetaxel thus excluding it from the system administration in the 2nd the 4th the 6th courses of polychemotherapy all the procedures are performed according to the method described in the protocol the evaluation of the therapeutic pathomorphosis of lesions in the peritoneum is carried out according to the PRGS system Peritoneal Regression Grading Score 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 group No 1 As the result of the treatment in the event of the complete regression of foci along the peritoneum and receiving Cy- in the peritoneal lavage after the completion of the planned treatment the patients switch to the dynamic observation or cytoreductive surgery is considered after the completion of polychemotherapy optionally by decision of the local council in case of the incomplete response due to the immeasurable characteristics of the tumor and the impossibility of evaluation by RECIST the dynamic observation is carried out until progression in case of progression the 2nd line of chemotherapy the scheme at the discretion of the attending physician or the optimal palliative care options depending on the clinical situation is considered accordingly the patient completes the therapy proposed by the study The method of performing the surgical manual is specified separately The response criteria are specified separately Shifting the timing of chemotherapy with dPIPAC sessions up to 10 days and the timing of control examinations up to 10 days due to objective circumstances is considered acceptable within the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None