Last reviewed · How we verify
NCT03279289: AFEMA
Study to Assess the Efficacy and Safety of Treatment With FOLFIRI-aflibercept Compared to Initial Treatment With FOLFIRI-aflibercept (for 6 Cycles) Followed by Maintenance With 5FU-aflibercept, in an Elderly Population With mCRC After Failure of an Oxaliplatin-based Regimen
Phase 2 trial testing Aflibercept in Metastatic Colorectal Cancer in 170 participants. Completed in 9 February 2023.
9 February 2023
Quick facts
| Lead sponsor | Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 170 |
| Start date | 25 October 2017 |
| Primary completion | 9 February 2023 |
| Estimated completion | 9 February 2023 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Aflibercept (AFLIBERCEPT) — full drug profile →
- Irinotecan (irinotecan) — full drug profile →
- folinic acid (dl racemic) — full drug profile →
- 5Fluorouracil
- 5-FU (5-fu) — full drug profile →
Conditions studied
- Metastatic Colorectal Cancer — all drugs for Metastatic Colorectal Cancer →
Sponsor
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Who can join
70 and older, any sex, with Metastatic Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to assess the efficacy and safety of treatment with FOLFIRI-aflibercept compared to initial treatment with FOLFIRI-aflibercept (for 6 cycles) followed by maintenance with 5FU-aflibercept, in an elderly population with metastatic colorectal cancer (mCRC) after failure of an oxaliplatin-based regimen
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Maintenance with 5-FU/LV-aflibercept after induction with FOLFIRI-aflibercept versus FOLFIRI-aflibercept until progression as second-line treatment in older adults with metastatic colorectal cancer: the AFEMA phase II randomized trial.
García-Alfonso P, Elez E, Soto-Alsar J, Páez D, et al · · 2024 · cited 1× · PMID 39608305 · DOI 10.1016/j.esmoop.2024.103986
Verify or expand the search:
- PubMed search for NCT03279289
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Aflibercept
Trials testing the same drug.
- NCT07496567 — A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-003) · Phase 2, PHASE3 · not yet recruiting
- NCT07440225 — A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002) · Phase 2, PHASE3 · recruiting
- NCT07482176 — Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-related Macular Deg · Phase 3 · recruiting
- NCT06856577 — Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-Related Macular Deg · Phase 3 · recruiting
- NCT06839339 — Efficacy and Safety of AL-001 Ophthalmic Injection in Subjects with WAMD · Phase 2 · not yet recruiting
Other recruiting trials for Metastatic Colorectal Cancer
Currently open trials in the same condition.
- NCT07416552 — A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC) · Phase 1 · recruiting
- NCT07314294 — Phase II Study of EMB-01 in Recurrent/Metastatic Colorectal Cancer Patients · Phase 2 · recruiting
- NCT06856837 — - IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Misma · Phase 2 · recruiting
- NCT06959550 — Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorect · Phase 2 · recruiting
- NCT06808685 — Real World Multicenter National Study to Evaluate the Effectiveness and Safety of Biosimilar Bevacizumab Elovie · recruiting
Other Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) trials
Trials by the same sponsor.
- NCT06892054 — Sotorasib Combined With First-line Chemotherapy for Advanced Pancreatic Adenocarcinoma · Phase 2 · not yet recruiting
- NCT06207656 — Study to Evaluate the Efficacy and Safety of Cetuximab in Combination with Encorafenib Plus Binimetinib As Induction Tre · Phase 2 · recruiting
- NCT05659914 — Olaparib and Durvalumab (MEDI4736) in Patients with Metastatic Pancreatic Cancer and DNA Damage Repair Genes Alterations · Phase 2 · active not recruiting
- NCT03635021 — Study to Evaluate the Efficacy of FOLFOX + Panitumumab Followed by FOLFIRI + Bevacizumab (Sequence 1) Versus FOLFOX + Be · Phase 3 · active not 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 NCT03279289 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
- Last refreshed: 13 April 2023
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/NCT03279289.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing