A Phase 2 interventional study of observation alone in Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma and Non Metastatic Disease, sponsored by Centre Leon Berard. Not yet recruiting at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-18.
Sponsored by Centre Leon Berard · Phase 2, Interventional, and Treatment
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:
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's planned enrollment of 120 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Centre Leon Berard is the lead sponsor of 206 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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.
Exclusion Criteria:
E7. Contraindication to postoperative treatment (FLOT):
Other: observation alone
Patients will received 4 cycles of FLOT after surgery.
Patient will not received post-operative chemotherapy. There will be only surveillance until progression.
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.
Time frame: 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.
Time frame: Time from the date of randomisation to 3 year post-randomisation follow-up visit
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).
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)
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.
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
The relapses will be described by their location (either locoregional or distant relapse).
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
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.
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
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.
Time frame: 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.
Time frame: 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.
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
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).
Time frame: 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.
Time frame: 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).
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
The physical performance will be assessed at baseline and during the course of treatment by a descriptive analysis of handgrip test.
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)
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).
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
The nutritional status will be assessed at baseline and during the course of treatment by a descriptive analysis of 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
The nutritional status will be assessed at baseline and during the course of treatment by a descriptive analysis of 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
The nutritional status will be assessed at baseline and during the course of treatment by a descriptive analysis of body mass index (BMI) evaluation.
Time frame: At baseline, every 3 months visits during the first 2 years then every 6 months until 3 years post-randomisation.
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centre Leon Berard