Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal CarcinomaPhase 2ATTENUATIONNCT06933966
Evaluation of Efficacy and Safety De-escalation Versus Standard Adjuvant Chemotherapy in Patients With Low Risk Localized Gastroesophageal Adenocarcinoma
A Phase 2 study testing observation alone in people with Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma and Non Metastatic Disease, run by Centre Leon Berard at 3 sites in France.
Trial summary
The ATTENUATION study targets patients with gastric adenocarcinoma (GA), esophageal adenocarcinoma (EAC) or gastro-esophageal junction (GEJ) who have received 4 cycles of FLOT chemotherapy before the surgery. Standard post-operative management consists of chemotherapy with 4 cycles of FLOT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma, Non Metastatic Disease
- What is being tested?
- observation alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Sep 2025to 1 Sep 2032
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- I1. Age ≥ 18 years, I2. Histologically proven non-metastatic (M0) gastric, oesophageal or gastroesophageal junction adenocarcinoma, I3. Subjects must have completed both pre-operative chemotherapy with a fluoropyrimidine-platinum containing regimen (FLOT 4 cycles) and microscopically complete (R0) resection prior to randomization.
- Note for surgery: total or distal gastrectomy with D2 lymphadenectomy according to ESMO guidelines should have been completed for gastric and junctional Siewert type III cancers. Ivor Lewis oesophagectomy with two field lymphadenectomy should have been performed for junctional Siewert type I cancers and lower oesophageal adenocarcinomas. For Siewert type II cancers either total gastrectomy with D2-lymphadenectomy or oesophagectomy with two field lymphadenectomy should have been completed. Open, minimal invasive or hybrid surgical approaches are acceptable as long as the requirements above are fulfilled. In frail patients with Siewert I or II, transhiatal oesophagectomy with lymphadenectomy in the lower mediastinum without transthoracic access is acceptable. Regardless of the type of surgery a minimum of 16 (gastric cancer) or 7 lymph nodes (in case of oesophageal carcinoma) should have been resected and examined (ref TNM 8 eme edition)
- I4. Low risk of disease recurrence, defined by the following criteria:
- Absence of lymph node involvement (ypN0), assessed on a min. of 16 or 7 lymph nodes according to the localization and,
- Either ypT0-2 (all TRG grade) or ypT3 (with TRG 1a-b according to Becker classification or TRG1-2 according to Mandard's classification), I5. ECOG Performance Status 0-1, I6. Patients fit to receive post-operative chemotherapy, I7. Interval between the date of surgery and the date of randomization no longer than 10 weeks, I8. Adequate organs function defined as : Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; Platelets ≥ 100 x 109/L; Haemoglobin ≥ 9 g/dL (without transfusion within 7 days); Serum creatinine AND Calculated creatinine clearance as per MDRD or CKD-EPI formula ≤ 1.5 upper limit of normal (ULN) AND ≥ 40 mL/min /1.73m²; Serum total bilirubin ≤ 1.5 ULN OR Direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 ULN (except for patients with Gilbert disease for whom a total serum bilirubin ≤ 3ULN is acceptable); AST and ALT ≤ 3 ULN; International Normalized Ratio (INR) and activated Partial Thromboplastin Time (aPTT)≤ 1.5 ULN .
- I9. No contraindication to study assessments, I10. Signed and dated informed consent for prior to any study-specific procedure, I11. Women of childbearing potential accepting to use highly effective contraceptive measures or abstain from heterosexual activity, for the course of the study and at least an- 9 months after the end of the treatment with oxaliplatin - 6 months after the end of the treatment with fluorouracil - 2 months after the end of the treatment with docetaxel and men must use contraception during treatment and at least - 6 months after the end of the treatment with oxaliplatin, - 3 months after the end of the treatment with fluorouracil - 4 months after the end of the treatment with docetaxel.
- I12. Patient must be covered by a medical insurance or equivalent.
Who cannot join
- E1. Oesophageal squamous cell carcinomas, E2. Tumour with Deficient MisMatch Repair (MMR) and/or Microsatellite Instability status, E3. Dihydro Pyrimidine Dehydrogenase (DPD) deficiency, NB: if not previously done, the following blood chemistry level must be perform at screening, : blood uracil level - uracilemia dosing result is mandatory prior the inclusion E4. Persistent toxicities related to prior treatment of grade>1, E5. QTcF longer than 450 msec for men and longer than 470 msec for women, E6. Hypokalemia OR Hypomagnesemia OR Hypocalcemia Grade>1
- E7. Contraindication to postoperative treatment (FLOT):
- Known history of hypersensitivity to fluorouracil, oxaliplatin, docetaxel or calcium folinate to any of their excipients, according to the SmPCs of these products OR
- Peripheral sensory neuropathy with functional impairment prior to first treatment according the SmPC of oxaliplatin OR
- Clinically significant active heart disease or myocardial infarction within 6 months OR
- Recent or concomitant treatment with brivudine or recent treatment with live vaccines (minimal wash out period before randomisation: 4 weeks) E8. Any concurrent chemotherapy, Investigational product for cancer treatment. E9. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study E10. Suspicion of serious infection, E11. Pregnant or breastfeeding woman, E12. Patient under tutorship or curatorship of deprived of liberty.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites
Centre Léon Bérard
Lyon, 69373
Clélia COUTZAC, MD, +33469856020, Clelia.coutzac@lyon.unicancer.fr
Institut Paoli-Calmettes
Marseille, 13009
Christelle DE LA FOUCHARDIERE, MD, +33491223333, delafouchardierec@ipc.unicancer.fr
AP-HP - Hôpital Saint-Antoine
Paris, 75012
Thibault VORON, MD, +33171970187, thibault.voron@aphp.fr
About this study
Official title: ATTENUATION - A Multicenter Randomized Phase II Study of the Efficacy and Safety De-escalation Versus Standard Adjuvant Chemotherapy in Patients With Low Risk Localized Gastroesophageal Adenocarcinoma (PRODIGE99/FRENCH 39 Study)
The ATTENUATION study targets patients with gastric adenocarcinoma (GA), esophageal adenocarcinoma (EAC) or gastro-esophageal junction (GEJ) who have received 4 cycles of FLOT chemotherapy before the surgery. Standard post-operative management consists of chemotherapy with 4 cycles of FLOT.
However, the nature and duration of postoperative treatment are standardized and are not adapted to the specific tumor response of each patient. All patients are therefore referred to the same treatment regimen.
Read more
As a result, good responders (defined in particular by wide resection of the tumor and a good response to preoperative chemotherapy on the tumor removed during surgery) may be over-treated and exposed to unnecessary adverse events.
Only 50-60% of patients can start chemotherapy post-operatively, due to the potential residual adverse effects associated with surgery in particular. Thus, it would appear that preoperative chemotherapy is the most important factor in the overall efficacy of the treatment sequence. Moreover, numerous retrospective studies have reported a favorable outcome in patients with a major response to pre-operative treatment but who were unable to receive post-operative chemotherapy.
The hypothesis of this study is that surveillance after surgery in patients with gastric or gastroesophageal junction tumors, with a good response to preoperative chemotherapy could provide significant clinical benefit and favorable disease progression.
Participants will:
- be distributed in one of the two arms
- will be followed up every 3 months for 2 years, then every 6 months (clinical examination, imaging, quality-of-life questionnaire) subsequent years until 3 years after the randomization of the last patient.
- followed up until their death or their progression whether local, regional or metastatic.
- Conditions
- Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma, Non Metastatic Disease
- Being tested
- observation alone
- Keywords
- De-escalation post-operative chemotherapy, Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Adenocarcinoma
- Medical subject headings
- Esophageal Neoplasms, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observation aloneOther
Patient will not received post-operative chemotherapy. There will be only surveillance until progression.
| Study group | Role | What they receive |
|---|---|---|
| Experimental strategy: surveillance without FLOT post-operative chemotherapy | Experimental | Not described Receives: Other: observation alone |
| Standard strategy : post-operative chemotherapy (4 cycles of FLOT) | No intervention | Patients will received 4 cycles of FLOT after surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 year Overall Survival rate
The primary endpoint will the 3-year Overall Survival (OS) rate, described as the proportion of patients still alive 3 years after the date of randomization.
Measured: From the date of randomisation to 3 years post-randomisation follow-up visit.
3 year disease-free survival rate
The co-primary endpoint is the 3-year Disease-Free Survival rate, considered as a binary variable with a success defined as being relapse-free at 3 years.
Measured: Time from the date of randomisation to 3 year post-randomisation follow-up visit
Secondary outcomes (15)
Overall survival
The overall survival (OS) will be defined as the time from the date of randomization to the date of death due to any cause or to the date of last contact if patient is still alive (censored patients).
Measured: Time from the date of randomisation to the date of death due to any cause or to the date of last contact if patient is still alive (censored patients), assessed up to 60 months.
Disease-Free Survival (DFS)
The Disease-Free Survival (DFS) will be defined as the time from the date of randomization to the date of the first documented relapse of the disease or death due to any cause, whichever occurs first. Patients alive and disease-free at the time of the analysis will be censored at the date of their last tumoral evaluation.
Measured: From the date of randomization to the date of the first documented relapse of the disease or death due to any cause, whichever occurs first, assessed up to 60 months.
Type of Relapses
The relapses will be described by their location (either locoregional or distant relapse).
Measured: From the date of randomization to the date of the first documented relapse of the disease, assessed up to 60 months.
The tolerability profile
The tolerability profile will be assessed continuously using the NCI-CTC AE version 5.0. All Adverse Events (AE), whichever their relationship with study treatments, all Serious AE, all Suspected Unexpected Serious Adverse Reactions and all toxic deaths, will be reported.
Measured: From date of randomization to 3 years follow-up visit or death due to any cause, whichever came first, assessed up to 60 months
The health-related quality of life by QLQ-C30
The health-related quality of life will be assessed using the EORTC Quality of Life Questionnaire (QLQ-C30). Descriptive statistics and graphs will be reported to evaluate Quality of life in the 2 study arms. Mixed model for repeated measure and time to deterioration will be used to analyse longitudinal Quality of life.
Measured: At Baseline and every year after randomisation during 3 years.
The nutritional status by food intake changes
The nutritional status will be assessed at baseline and during the course of treatment by a descriptive analysis of food intake changes.
Measured: At baseline, every 3 months visits during the first 2 years then every 6 months until 3 years post-randomisation.
ctDNA positivity
The ctDNA positivity will be described in each arm in terms of proportion of positivity at each time point and delay between ctDNA positivity and recurrence documented on imaging.
Measured: At baseline, every 3 months visits during the first 2 years then every 6 months until 3 years post-randomisation.
The feasibility of using a standardized pathological report
The feasibility of using a standardized pathological report will be described in the whole study population by the adherence to the standardized report (proportion of patients with a report and quality of filling).
Measured: At baseline visit only
The health-related quality of life by QLQ-OG25
The health-related quality of life will be assessed using the Gastric Cancer module (EORTC QLQ-OG25). Descriptive statistics and graphs will be reported to evaluate Quality of life in the 2 study arms. Mixed model for repeated measure and time to deterioration will be used to analyse longitudinal Quality of life.
Measured: At Baseline and every year after randomisation during 3 years.
The nutritional status by sarcopenia
The nutritional status will be assessed at baseline and during the course of treatment by a descriptive analysis of sarcopenia. It will be analysed with muscle mass evaluation (computed tomography scans at lumbar level 3).
Measured: At baseline, every 3 months visits during the first 2 years then every 6 months until 3 years post-randomisation.
The physical performance
The physical performance will be assessed at baseline and during the course of treatment by a descriptive analysis of handgrip test.
Measured: At baseline, every 3 months visits during the first 2 years then every 6 months until 3 years post-randomisation.
The nutritional status by systemic inflammation (CRP)
The nutritional status will be assessed at baseline and during the course of treatment by a descriptive analysis of measurements of serum C-reactive protein (CRP).
Measured: At baseline, every 3 months visits during the first 2 years then every 6 months until 3 years post-randomisation.
The nutritional status by measurements of albumin
The nutritional status will be assessed at baseline and during the course of treatment by a descriptive analysis of measurements of albumin.
Measured: At baseline, every 3 months visits during the first 2 years then every 6 months until 3 years post-randomisation.
The nutritional status by weight changes
The nutritional status will be assessed at baseline and during the course of treatment by a descriptive analysis of weight changes.
Measured: At baseline, every 3 months visits during the first 2 years then every 6 months until 3 years post-randomisation.
The nutritional status by body mass index evaluation
The nutritional status will be assessed at baseline and during the course of treatment by a descriptive analysis of body mass index (BMI) evaluation.
Measured: At baseline, every 3 months visits during the first 2 years then every 6 months until 3 years post-randomisation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal CarcinomaStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- 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
- Model description
- Patients will be randomized according to the foloowing stratification criteria: * Primary tumour location (gastric vs gastro-esophageal junction and lower esophagus) * TRG score (Becker (B) or Mandard (M) classification): low (TRG 1a-b (B)/1-2 (M)) vs high (TRG 2-3 (B)/3-5 (M))
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christelle DE LA FOUCHARDIERE, MD, Principal investigator, Institut Paoli-Calmettes, Department of Medical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933966
- Sponsor's protocol ID
- ET23-350
- Other IDs
- 2023-509227-41-00, 2023
- Acronym
- ATTENUATION
- Status last verified
- Apr 2025
- First submitted
- 21 Mar 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ATTENUATION - A Multicenter Randomized Phase II Study of the Efficacy and Safety De-escalation Versus Standard Adjuvant Chemotherapy in Patients With Low Risk Localized Gastroesophageal Adenocarcinoma (PRODIGE99/FRENCH 39 Study)
- ClinicalTrials.gov ID
- NCT06933966
- Acronym / sponsor ID
- ATTENUATION / ET23-350
- Conditions
- Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma, Non Metastatic Disease
- Keywords
- De-escalation post-operative chemotherapy, Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Sep 2032 (estimated)
- First posted
- 18 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.
The ATTENUATION study targets patients with gastric adenocarcinoma (GA), esophageal adenocarcinoma (EAC) or gastro-esophageal junction (GEJ) who have received 4 cycles of FLOT chemotherapy before the surgery. Standard post-operative management consists of chemotherapy with 4 cycles of FLOT.
However, the nature and duration of postoperative treatment are standardized and are not adapted to the specific tumor response of each patient. All patients are therefore referred to the same treatment regimen.
As a result, good responders (defined in particular by wide resection of the tumor and a good response to preoperative chemotherapy on the tumor removed during surgery) may be over-treated and exposed to unnecessary adverse events.
Only 50-60% of patients can start chemotherapy post-operatively, due to the potential residual adverse effects associated with surgery in particular. Thus, it would appear that preoperative chemotherapy is the most important factor in the overall efficacy of the treatment sequence. Moreover, numerous retrospective studies have reported a favorable outcome in patients with a major response to pre-operative treatment but who were unable to receive post-operative chemotherapy.
The hypothesis of this study is that surveillance after surgery in patients with gastric or gastroesophageal junction tumors, with a good response to preoperative chemotherapy could provide significant clinical benefit and favorable disease progression.
Participants will:
- be distributed in one of the two arms
- will be followed up every 3 months for 2 years, then every 6 months (clinical examination, imaging, quality-of-life questionnaire) subsequent years until 3 years after the randomization of the last patient.
- followed up until their death or their progression whether local, regional or metastatic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized according to the foloowing stratification criteria: * Primary tumour location (gastric vs gastro-esophageal junction and lower esophagus) * TRG score (Becker (B) or Mandard (M) classification): low (TRG 1a-b (B)/1-2 (M)) vs high (TRG 2-3 (B)/3-5 (M))
| Arm | Type | Receives |
|---|---|---|
| Experimental strategy: surveillance without FLOT post-operative chemotherapy | Experimental | Other: observation alone |
| Standard strategy : post-operative chemotherapy (4 cycles of FLOT) | No intervention | –Patients will received 4 cycles of FLOT after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- I1. Age ≥ 18 years, I2. Histologically proven non-metastatic (M0) gastric, oesophageal or gastroesophageal junction adenocarcinoma, I3. Subjects must have completed both pre-operative chemotherapy with a fluoropyrimidine-platinum containing regimen (FLOT 4 cycles) and microscopically complete (R0) resection prior to randomization.
- Note for surgery: total or distal gastrectomy with D2 lymphadenectomy according to ESMO guidelines should have been completed for gastric and junctional Siewert type III cancers. Ivor Lewis oesophagectomy with two field lymphadenectomy should have been performed for junctional Siewert type I cancers and lower oesophageal adenocarcinomas. For Siewert type II cancers either total gastrectomy with D2-lymphadenectomy or oesophagectomy with two field lymphadenectomy should have been completed. Open, minimal invasive or hybrid surgical approaches are acceptable as long as the requirements above are fulfilled. In frail patients with Siewert I or II, transhiatal oesophagectomy with lymphadenectomy in the lower mediastinum without transthoracic access is acceptable. Regardless of the type of surgery a minimum of 16 (gastric cancer) or 7 lymph nodes (in case of oesophageal carcinoma) should have been resected and examined (ref TNM 8 eme edition)
- Absence of lymph node involvement (ypN0), assessed on a min. of 16 or 7 lymph nodes according to the localization and,
- Either ypT0-2 (all TRG grade) or ypT3 (with TRG 1a-b according to Becker classification or TRG1-2 according to Mandard's classification), I5. ECOG Performance Status 0-1, I6. Patients fit to receive post-operative chemotherapy, I7. Interval between the date of surgery and the date of randomization no longer than 10 weeks, I8. Adequate organs function defined as : Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; Platelets ≥ 100 x 109/L; Haemoglobin ≥ 9 g/dL (without transfusion within 7 days); Serum creatinine AND Calculated creatinine clearance as per MDRD or CKD-EPI formula ≤ 1.5 upper limit of normal (ULN) AND ≥ 40 mL/min /1.73m²; Serum total bilirubin ≤ 1.5 ULN OR Direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 ULN (except for patients with Gilbert disease for whom a total serum bilirubin ≤ 3ULN is acceptable); AST and ALT ≤ 3 ULN; International Normalized Ratio (INR) and activated Partial Thromboplastin Time (aPTT)≤ 1.5 ULN .
- I9. No contraindication to study assessments, I10. Signed and dated informed consent for prior to any study-specific procedure, I11. Women of childbearing potential accepting to use highly effective contraceptive measures or abstain from heterosexual activity, for the course of the study and at least an- 9 months after the end of the treatment with oxaliplatin - 6 months after the end of the treatment with fluorouracil - 2 months after the end of the treatment with docetaxel and men must use contraception during treatment and at least - 6 months after the end of the treatment with oxaliplatin, - 3 months after the end of the treatment with fluorouracil - 4 months after the end of the treatment with docetaxel.
Key exclusion criteria (6 listed)
- E1. Oesophageal squamous cell carcinomas, E2. Tumour with Deficient MisMatch Repair (MMR) and/or Microsatellite Instability status, E3. Dihydro Pyrimidine Dehydrogenase (DPD) deficiency, NB: if not previously done, the following blood chemistry level must be perform at screening, : blood uracil level - uracilemia dosing result is mandatory prior the inclusion E4. Persistent toxicities related to prior treatment of grade>1, E5. QTcF longer than 450 msec for men and longer than 470 msec for women, E6. Hypokalemia OR Hypomagnesemia OR Hypocalcemia Grade>1
- Known history of hypersensitivity to fluorouracil, oxaliplatin, docetaxel or calcium folinate to any of their excipients, according to the SmPCs of these products OR
- Peripheral sensory neuropathy with functional impairment prior to first treatment according the SmPC of oxaliplatin OR
- Clinically significant active heart disease or myocardial infarction within 6 months OR
- Recent or concomitant treatment with brivudine or recent treatment with live vaccines (minimal wash out period before randomisation: 4 weeks) E8. Any concurrent chemotherapy, Investigational product for cancer treatment. E9. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study E10. Suspicion of serious infection, E11. Pregnant or breastfeeding woman, E12. Patient under tutorship or curatorship of deprived of liberty.
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 |
|---|---|---|
| observation alonePatient will not received post-operative chemotherapy. There will be only surveillance until progression. | Other | Experimental strategy: surveillance without FLOT post-operative chemotherapy |
Primary outcome
3 year Overall Survival rate
Time frame: From the date of randomisation to 3 years post-randomisation follow-up visit.
The primary endpoint will the 3-year Overall Survival (OS) rate, described as the proportion of patients still alive 3 years after the date of randomization.
3 year disease-free survival rate
Time frame: Time from the date of randomisation to 3 year post-randomisation follow-up visit
The co-primary endpoint is the 3-year Disease-Free Survival rate, considered as a binary variable with a success defined as being relapse-free at 3 years.
15 secondary outcomes
Overall survival
Time frame: Time from the date of randomisation to the date of death due to any cause or to the date of last contact if patient is still alive (censored patients), assessed up to 60 months.
Disease-Free Survival (DFS)
Time frame: From the date of randomization to the date of the first documented relapse of the disease or death due to any cause, whichever occurs first, assessed up to 60 months.
Type of Relapses
Time frame: From the date of randomization to the date of the first documented relapse of the disease, assessed up to 60 months.
The tolerability profile
Time frame: From date of randomization to 3 years follow-up visit or death due to any cause, whichever came first, assessed up to 60 months
The health-related quality of life by QLQ-C30
Time frame: At Baseline and every year after randomisation during 3 years.
The nutritional status by food intake changes
Time frame: At baseline, every 3 months visits during the first 2 years then every 6 months until 3 years post-randomisation.
ctDNA positivity
Time frame: At baseline, every 3 months visits during the first 2 years then every 6 months until 3 years post-randomisation.
The feasibility of using a standardized pathological report
Time frame: At baseline visit only
The health-related quality of life by QLQ-OG25
Time frame: At Baseline and every year after randomisation during 3 years.
The nutritional status by sarcopenia
Time frame: At baseline, every 3 months visits during the first 2 years then every 6 months until 3 years post-randomisation.
The physical performance
Time frame: At baseline, every 3 months visits during the first 2 years then every 6 months until 3 years post-randomisation.
The nutritional status by systemic inflammation (CRP)
Time frame: At baseline, every 3 months visits during the first 2 years then every 6 months until 3 years post-randomisation.
The nutritional status by measurements of albumin
Time frame: At baseline, every 3 months visits during the first 2 years then every 6 months until 3 years post-randomisation.
The nutritional status by weight changes
Time frame: At baseline, every 3 months visits during the first 2 years then every 6 months until 3 years post-randomisation.
The nutritional status by body mass index evaluation
Time frame: At baseline, every 3 months visits during the first 2 years then every 6 months until 3 years post-randomisation.
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 18 Apr 2025.
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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.
Christelle DE LA FOUCHARDIERE, MD principal investigator
Institut Paoli-Calmettes, Department of Medical Oncology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing observation alone in people with Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma and Non Metastatic Disease, run by Centre Leon Berard at 3 sites in France.
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 7 inclusion and 6 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 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Séverine METZGER (+ 33478782786, severine.metzger@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 year Overall Survival rate (time frame: From the date of randomisation to 3 years post-randomisation follow-up visit.). The study lists 2 primary outcomes in all. 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 18 Apr 2025.