Gastric CancerPhase 2JAGC1NCT06942663
Randomized Phase II Trial Evaluating DFS in The Absence of an Adjuvant Component of Perioperative Chemotherapy in Patients With Gastric Cancer
A Phase 2 study testing Surveillance and Adjuvant Chemotherapy in people with Gastric Cancer, run by Nizhny Novgorod Regional Clinical Oncology Center.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Surveillance and Adjuvant Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2025to 1 Nov 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Obtaining informed consent to participate in the study.
- Morphologically confirmed gastric adenocarcinoma.
- The presence of localized or locally advanced gastric cancer (cT2-4a and/or N+)
- The full volume of the planned neoadjuvant component of perioperative chemotherapy was performed
- Radical surgical intervention was performed for the primary tumor of gastric cancer
- The histological degree of tumor regression after surgical resection was classified TRG1 and without metastasis to regional lymph nodes N0 or TRG 4-5 based on the Mandard tumor Regression scale.
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- ECOG score 0 - I.
- Absence of severe uncontrolled concomitant chronic and acute diseases.
- Adequate liver and bone marrow function
- Neutrophils > 1.5*109/l
- Hemoglobin >85 g/l
- Platelets >100*109/l
- Increased transaminases and/or bilirubin < 2 art.
Who cannot join
- Lack of a neoadjuvant component of perioperative chemotherapy or insufficient number of courses
- The time after surgical treatment is more than 12 weeks
- Stage IV of the disease
- Her2-positive and/or MSI\dMMR stomach cancer
- Severe uncontrolled concomitant chronic or acute diseases
- The presence of a second malignant tumor (with the exception of previously cured malignant neoplasms)
- Any conditions that, in the opinion of the doctor, interfere with the examination procedures
- With incomplete tumor response to treatment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Randomized Phase II Trial Evaluating DFS in the Absence of an Adjuvant Component of Perioperative Chemotherapy in Patients With Stage IB-III Gastric Cancer Who Achieved pCR or TRG4-5 on the Mandard Scale on Neoadjuvant Chemotherapy
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.
Read the detailed description
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:
- Group A (no adjuvant therapy): Patients will not receive adjuvant chemotherapy
- Group B (adjuvant therapy): Patients will receive the adjuvant component of perioperative chemotherapy
Patients who achieve a TRG of 4-5 on the Mandard scale will be randomly assigned to one of two groups:
- Group C (adjuvant therapy): Patients will not receive adjuvant chemotherapy.
- Group D (no adjuvant therapy): Patients will receive the adjuvant component of perioperative chemotherapy.
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).
- Conditions
- Gastric Cancer
- Being tested
- Surveillance, Adjuvant Chemotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveillanceOther
Close monitoring for disease recurrence.
Adjuvant ChemotherapyDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Group A ( patients with pCR - no adjuvant therapy ) | Experimental | Patients will not receive adjuvant chemotherapy Receives: Other: Surveillance |
| Group B ( patients with pCR - adjuvant therapy ) | Active comparator | Patients will receive an adjuvant component of perioperative chemotherapy Receives: Drug: Adjuvant Chemotherapy |
| Group C ( patients with TRG of 4-5 - no adjuvant therapy ) | Experimental | Patients will not receive adjuvant chemotherapy. Receives: Other: Surveillance |
| Group D ( patients with TRG of 4-5 - adjuvant therapy ) | Active comparator | Patients will receive an adjuvant component of perioperative chemotherapy Receives: Drug: Adjuvant Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (1)
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).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start15 Apr 2025 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nizhny Novgorod Regional Clinical Oncology Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sergey Gamayunov, DMS, Study director, RESEARCH INSTITUTE OF CLINICAL ONCOLOGY "NIZHNY NOVGOROD REGIONAL CLINICAL ONCOLOGICAL DISPENSARY"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942663
- Sponsor's protocol ID
- JAGC - 1
- Acronym
- JAGC1
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial Evaluating DFS in the Absence of an Adjuvant Component of Perioperative Chemotherapy in Patients With Stage IB-III Gastric Cancer Who Achieved pCR or TRG4-5 on the Mandard Scale on Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT06942663
- Acronym / sponsor ID
- JAGC1 / JAGC - 1
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Nizhny Novgorod Regional Clinical Oncology CenterOther government
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2030 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Group A (no adjuvant therapy): Patients will not receive adjuvant chemotherapy
- Group B (adjuvant therapy): Patients will receive the adjuvant component of perioperative chemotherapy
Patients who achieve a TRG of 4-5 on the Mandard scale will be randomly assigned to one of two groups:
- Group C (adjuvant therapy): Patients will not receive adjuvant chemotherapy.
- Group D (no adjuvant therapy): Patients will receive the adjuvant component of perioperative chemotherapy.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A ( patients with pCR - no adjuvant therapy ) | Experimental | Other: SurveillancePatients will not receive adjuvant chemotherapy |
| Group B ( patients with pCR - adjuvant therapy ) | Active comparator | Drug: Adjuvant ChemotherapyPatients will receive an adjuvant component of perioperative chemotherapy |
| Group C ( patients with TRG of 4-5 - no adjuvant therapy ) | Experimental | Other: SurveillancePatients will not receive adjuvant chemotherapy. |
| Group D ( patients with TRG of 4-5 - adjuvant therapy ) | Active comparator | Drug: Adjuvant ChemotherapyPatients will receive an adjuvant component of perioperative chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- - Obtaining informed consent to participate in the study.
- Morphologically confirmed gastric adenocarcinoma.
- The presence of localized or locally advanced gastric cancer (cT2-4a and/or N+)
- The full volume of the planned neoadjuvant component of perioperative chemotherapy was performed
- Radical surgical intervention was performed for the primary tumor of gastric cancer
Key exclusion criteria (8 listed)
- Lack of a neoadjuvant component of perioperative chemotherapy or insufficient number of courses
- The time after surgical treatment is more than 12 weeks
- Stage IV of the disease
- Her2-positive and/or MSI\dMMR stomach cancer
- Severe uncontrolled concomitant chronic or acute diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveillanceClose monitoring for disease recurrence. | Other | Group A ( patients with pCR - no adjuvant therapy ), Group C ( patients with TRG of 4-5 - no adjuvant therapy ) |
| Adjuvant ChemotherapyThe 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). | Drug | Group B ( patients with pCR - adjuvant therapy ), Group D ( patients with TRG of 4-5 - adjuvant therapy ) |
Primary outcome
Disease-free survival rates
Time frame: 3 years
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.
1 secondary outcome
Аssessment of the quality of life
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sergey Gamayunov, DMS study director
RESEARCH INSTITUTE OF CLINICAL ONCOLOGY "NIZHNY NOVGOROD REGIONAL CLINICAL ONCOLOGICAL DISPENSARY"
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surveillance and Adjuvant Chemotherapy in people with Gastric Cancer, run by Nizhny Novgorod Regional Clinical Oncology Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petryakova Alex Julia, MD (79873940672, petryakovajulia@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival rates (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.