NCT02661971: RAMSES/FLOT7

Perioperative RAMucirumab in Combination With FLOT Versus FLOT Alone for reSEctable eSophagogastric Adenocarcinoma - RAMSES - a Phase II/III Trial of the AIO

Completed Phase 2/Phase 3 Last updated 8 July 2022

What this trial tests

Phase 2/Phase 3 trial testing Docetaxel in Stomach Cancer in 180 participants. Completed in 20 June 2022.

Timeline

1 June 2016

Primary endpoint
1 December 2021

20 June 2022

Quick facts

Lead sponsor	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	180
Start date	1 June 2016
Primary completion	1 December 2021
Estimated completion	20 June 2022
Sites	2 locations across Germany, Italy

Drugs / interventions tested

• Docetaxel (Docetaxel) — full drug profile →
• Oxaliplatin (Oxaliplatin) — full drug profile →
• Calciumfolinat — full drug profile →
• 5-Fluorouracil
• Ramucirumab (RAMUCIRUMAB) — full drug profile →

Conditions studied

• Stomach Cancer — all drugs for Stomach Cancer →
• Gastroesophageal Junction Cancer — all drugs for Gastroesophageal Junction Cancer →

Sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest — full company profile →

Who can join

Adults 18 to 70, any sex, with Stomach Cancer or Gastroesophageal Junction Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Phase II: Rate of pathological complete or subtotal responses (pCR/pSR): assessed according to Becker remission criteria
  Time frame: 3 years
• Phase III: Overall Survival (OS): time from randomization to death of any cause
  Time frame: 3 years
  Survival rates for the different time points will be determined using the Kaplan-Meier analysis of OS.

Sponsor's own description

Previous studies provide a strong theoretical rationale for the conduct of a randomized study evaluating the efficacy and safety of ramucirumab in combination with FLOT in the perioperative treatment of resectable adenocarcinoma of the stomach or GEJ.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. CRITICS-II: a multicentre randomised phase II trial of neo-adjuvant chemotherapy followed by surgery versus neo-adjuvant chemotherapy and subsequent chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery in resectable gastric cancer.
   Slagter AE, Jansen EPM, van Laarhoven HWM, van Sandick JW, et al · · 2018 · cited 105× · PMID 30200910 · DOI 10.1186/s12885-018-4770-2
2. Angiogenesis and Anti-Angiogenic Therapy in Gastric Cancer.
   Nienhüser H, Schmidt T. · · 2017 · cited 82× · PMID 29295534 · DOI 10.3390/ijms19010043
3. Advances in the curative management of oesophageal cancer.
   Bolger JC, Donohoe CL, Lowery M, Reynolds JV. · · 2022 · cited 75× · PMID 34675397 · DOI 10.1038/s41416-021-01485-9
4. Perioperative Treatment in Resectable Gastric Cancer: Current Perspectives and Future Directions.
   Petrillo A, Pompella L, Tirino G, Pappalardo A, et al · · 2019 · cited 49× · PMID 30901943 · DOI 10.3390/cancers11030399
5. Recent Developments of Systemic Chemotherapy for Gastric Cancer.
   Arai H, Nakajima TE. · · 2020 · cited 37× · PMID 32354119 · DOI 10.3390/cancers12051100
6. New therapeutic options opened by the molecular classification of gastric cancer.
   Chivu-Economescu M, Matei L, Necula LG, Dragu DL, et al · · 2018 · cited 33× · PMID 29760539 · DOI 10.3748/wjg.v24.i18.1942
7. Extended Lymphadenectomy for Gastric Cancer in the Neoadjuvant Era: Current Status, Clinical Implications and Contentious Issues.
   Marano L, Carbone L, Poto GE, Restaino V, et al · · 2023 · cited 26× · PMID 36661716 · DOI 10.3390/curroncol30010067
8. Recent advances in the management of gastric adenocarcinoma patients.
   Harada K, Lopez A, Shanbhag N, Badgwell B, et al · · 2018 · cited 22× · PMID 30228868 · DOI 10.12688/f1000research.15133.1