Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This single-center, open-label, randomized phase II trial (JAGC-1) will evaluate whether adjuvant chemotherapy can be safely omitted in patients with stage IB-III gastric cancer (cT2-4a and/or N+) who have achieved a pathological complete response (pCR) or TRG 4-5 on the Mandard scale, following neoadjuvant chemotherapy and surgery. The study aims to compare disease-free survival and quality of life in patients receiving or not receiving adjuvant chemotherapy after neoadjuvant treatment and surgery.
Population: patients with localized or locally advanced gastric cancer ( cT2-4a and/or N+ according to TNM, 8th revision, 2017) after having undergone the full extent of the planned neoadjuvant component of perioperative chemotherapy, radical surgical intervention, with a histological tumor regression grade classified as pCR or TRG 4-5 according to the Mandard scale
Study design Patients will be randomized in a ratio of approximately 1:1:
Patients who achieve pCR will be randomly assigned to one of two groups:
Patients who achieve a TRG of 4-5 on the Mandard scale will be randomly assigned to one of two groups:
Patients in the groups with adjuvant therapy will receive treatment until progression or maximal effect of therapy is detected (the longest duration of treatment is 3 months).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A ( patients with pCR - no adjuvant therapy ) | Experimental | Patients will not receive adjuvant chemotherapy |
|
| Group B ( patients with pCR - adjuvant therapy ) | Active Comparator | Patients will receive an adjuvant component of perioperative chemotherapy |
|
| Group C ( patients with TRG of 4-5 - no adjuvant therapy ) | Experimental | Patients will not receive adjuvant chemotherapy. |
|
| Group D ( patients with TRG of 4-5 - adjuvant therapy ) | Active Comparator | Patients will receive an adjuvant component of perioperative chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surveillance | Other | Close monitoring for disease recurrence. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival rates | Comparison of 3-year DFS in the group receiving the adjuvant component of perioperative chemotherapy and in the group without it and comparison of the indicators of 3-year DFS with TRG 4-5 on the Mandard scale in the group receiving the adjuvant component of perioperative chemotherapy and in the group without it. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Аssessment of the quality of life | Quality of life assessment by European Organisation for Research and Treatment of Cancer scale Quality of Life Questionnaire - Core 30 (QLQ-C30) by Scoring of the QLQ-C30 Summary Score using the descriptive analysis with the qlqc30 command (detailed description in manual ISBN 2-9300 64-22-6). | 3 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Petryakova Alex Julia, MD | Contact | 79873940672 | petryakovajulia@mail.ru | |
| MIKHAIL Anat OSIPOV, MD, PhD | Contact | 89052075653 | ocipovmixail@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Sergey Gamayunov, DMS | RESEARCH INSTITUTE OF CLINICAL ONCOLOGY "NIZHNY NOVGOROD REGIONAL CLINICAL ONCOLOGICAL DISPENSARY" | Study Director |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Adjuvant Chemotherapy | Drug | The adjuvant chemotherapy regimen will be standardized based on current clinical guidelines and may include combinations of agents such as fluoropyrimidines and oxaliplatin with or without docetaxel. Treatment until the progression of the process is detected or the maximum effect of therapy is achieved (the maximum duration of treatment is 3 months). |
|
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
Not provided
Not provided