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NCT03961841
A Randomised Controlled Trial Comparing Perioperative FLOT, FOLFOX and Preoperative Chemoradiation for Locally Advanced Esophagogastric Junction Adenocarcinoma
Phase 3 trial testing chemoradiation with weekly 5Fu and oxaliplatin in Esophagogastric Junction Disorder in 900 participants. Not yet recruiting.
1 August 2024
Quick facts
| Lead sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
|---|---|
| Phase | Phase 3 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 900 |
| Start date | 1 June 2020 |
| Primary completion | 1 August 2024 |
| Estimated completion | 1 August 2029 |
Drugs / interventions tested
- chemoradiation with weekly 5Fu and oxaliplatin
- Perioperative mFLOT — full drug profile →
- Perioperative FOLFOX — full drug profile →
Conditions studied
- Esophagogastric Junction Disorder — all drugs for Esophagogastric Junction Disorder →
- Neoplasms — all drugs for Neoplasms →
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Who can join
Adults 18 to 75, any sex, with Esophagogastric Junction Disorder or Neoplasms. 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.
-
3 year of disease free survival
Time frame: 3 year
Sponsor's own description
Patients with histologically confirmed esophagogastric junction adenocarcinoma with pre-operative staging cT3-4N+M0，aged between 18-75 years old, with adequate organ function and having an Eastern Cooperative Oncology Group performance status score ≤2, are randomized in a 1:1:1 ratio to receive neoadjuvant chemoradiotherapy with DT46-50Gy plus concomitant weekly oxaliplatin and 5-Fu, perioperative chemotherapy of FLOT regimen or FOLFOX regimen. The primary end point is disease free survival (DFS), and secondary end point is 5-year overall survival (OS), pathological complete remission (pCR) and treatment safety. The final study analytics are to be conducted at the end of the 5th year after the last patient's enrollment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03961841
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Esophagogastric Junction Disorder
Currently open trials in the same condition.
- NCT04455282 — CIRCULATing Biomarkers for Individualized Surgical Therapy in gastroEsophageal Cancer - Phase 1 · recruiting
Other Sixth Affiliated Hospital, Sun Yat-sen University trials
Trials by the same sponsor.
- NCT07538284 — MInimizing Delirium With Nasal Dexmedetomidine-InducEd Sleep (MIDDIES) · Phase 2, PHASE3 · not yet recruiting
- NCT07176182 — Clinical Trial of Neoadjuvant mFOLFOX Plus Alvenor for LARC Patients With High YWHAB Expression · Phase 2 · not yet recruiting
- NCT07510191 — TNFi Plus Low-Dose Upadacitinib vs TNFi Intensification in Crohn's Disease With Suboptimal Response · Phase 4 · recruiting
- NCT07344428 — Efficacy and Safety of CDED With Anti-TNF-α Biologics in Crohn's Disease: A Randomized Trial · NA · not yet recruiting
- NCT07328958 — Effect of Titrated Administration of Ciprofol on Perioperative Hypotension in Elderly Patients Undergoing Laparoscopic A · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03961841 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sixth Affiliated Hospital, Sun Yat-sen University
- Last refreshed: 19 December 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03961841.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing