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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 (study PRODIGE/FRENCH 39)
EU CTIS ID: 2023-509227-41-00
What this study is testing
Evaluate the efficacy (3-year OS rate) of a de-escalation strategy (surveillance) compared to the standard post-operative chemotherapy schedule in patients with low-risk of relapse, previously treated with pre-operative chemotherapy (4 cycles of FLOT) and complete resection of a gastric, junctional or esophageal adenocarcinoma. The co-primary objective is to evaluate the 3-year Disease-Free Survival rate of the surveillance arm compared to the standard arm.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- I1. Age ≥ 18 years
- 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
- I2. Histologically proven non-metastatic (M0) gastric, esophageal 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 esophageal 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 esophageal carcinoma) should have been resected and examined (ref TNM 8 eme edition
You likely can't join if
- E1. Oesophageal squamous cell carcinomas
- E10. Suspicion of serious infection
- E11. Pregnant or breastfeeding woman
- E12. Patient under tutorship or curatorship of deprived of liberty.
- E2. Tumor 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
See the full eligibility criteria
Who can join
- I1. Age ≥ 18 years
- 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
- I2. Histologically proven non-metastatic (M0) gastric, esophageal 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 esophageal 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 esophageal 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 (ranges defined in the clinical trial protocol)
- I9. No contraindication to study assessments,
What rules you out
- E1. Oesophageal squamous cell carcinomas
- E10. Suspicion of serious infection
- E11. Pregnant or breastfeeding woman
- E12. Patient under tutorship or curatorship of deprived of liberty.
- E2. Tumor 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.