NCT06933966: ATTENUATION

Evaluation of Efficacy and Safety De-escalation Versus Standard Adjuvant Chemotherapy in Patients With Low Risk Localized Gastroesophageal Adenocarcinoma

Not yet recruiting Phase 2 Last updated 18 April 2025

What this trial tests

Phase 2 trial testing observation alone in Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma in 120 participants. Not yet recruiting.

Timeline

1 September 2025

Primary endpoint
1 September 2030

1 September 2032

Quick facts

Lead sponsor	Centre Leon Berard
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	1 September 2025
Primary completion	1 September 2030
Estimated completion	1 September 2032
Sites	3 locations across France

Drugs / interventions tested

• observation alone — full drug profile →

Conditions studied

• Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma — all drugs for Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma →
• Non Metastatic Disease — all drugs for Non Metastatic Disease →

Sponsor

Centre Leon Berard — full company profile →

Who can join

18 and older, any sex, with Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma or Non Metastatic Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.