NCT04389086 (PelvEx II) is a Phase 3 clinical trial of Combination drug in Recurrent Rectal Cancer, sponsored by Catharina Ziekenhuis Eindhoven.

Who is sponsoring NCT04389086?

NCT04389086 is sponsored by Catharina Ziekenhuis Eindhoven.

What drugs are being tested in NCT04389086?

Interventions in NCT04389086: Combination drug, Chemoradiotherapy, Surgery locally recurrent rectal cancer.

What condition does NCT04389086 study?

NCT04389086 studies Recurrent Rectal Cancer.

Is NCT04389086 still recruiting?

NCT04389086 is currently recruiting now. Last updated 6 September 2022.

Last reviewed 2022-09-06 · How we verify

NCT04389086: PelvEx II

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Induction Chemotherapy for Locally Recurrent Rectal Cancer

Recruiting now Phase 3 Last updated 6 September 2022

What this trial tests

Phase 3 trial testing Combination drug in Recurrent Rectal Cancer in 364 participants. Currently enrolling.

Timeline

13 November 2020

Primary endpoint
1 March 2024

1 March 2030

Quick facts

Lead sponsor	Catharina Ziekenhuis Eindhoven
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	364
Start date	13 November 2020
Primary completion	1 March 2024
Estimated completion	1 March 2030
Sites	14 locations across Netherlands, Belgium, Sweden, Norway, Portugal

Drugs / interventions tested

Combination drug
Chemoradiotherapy — full drug profile →
Surgery locally recurrent rectal cancer

Conditions studied

Recurrent Rectal Cancer — all drugs for Recurrent Rectal Cancer →

Sponsor

Catharina Ziekenhuis Eindhoven — full company profile →

Who can join

18 and older, any sex, with Recurrent Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicentre, open-label, parallel arms, phase IIII study that randomises patients with locally recurrent rectal cancer in a 1:1 ratio to receive either induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm)

Publications & conference data

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

Induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as neoadjuvant treatment for locally recurrent rectal cancer: study protocol of a multicentre, open-label, parallel-arms, randomized controlled study (PelvEx II).
PelvEx Collaborative. · · 2021 · cited 19× · PMID 34089596 · DOI 10.1093/bjsopen/zrab029
Reirradiation: Standards, challenges, and patient-focused strategies across tumor types.
Beddok A, Willmann J, Embring A, Appelt AL, et al · · 2025 · cited 14× · PMID 40438993 · DOI 10.3322/caac.70016
Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2024 for the treatment of colorectal cancer.
Kinugasa Y, Uehara K, Yamaguchi K, Saito Y, et al · · 2025 · cited 10× · PMID 41186794 · DOI 10.1007/s10147-025-02899-8

Verify or expand the search:

Other trials of Combination drug

Trials testing the same drug.

NCT07220616 — A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies · Phase 1, PHASE2 · recruiting
NCT04193982 — An Investigator Initiated Prospective, Four Arms Randomized Comparative Study of Efficacy and Safety of Saroglitazar, Vi · Phase 3 · unknown
NCT04125693 — Roll-over Study to Continue Treatment With the Investigational Drug Rogaratinib and to Further Test Its Safety · Phase 2 · completed
NCT04168398 — Clopidogrel Aspirin Therapy (CAT) Versus Apixiban Aspirin Therapy (AAT) After Lower Limb Revascularization · Phase 1, PHASE2 · completed
NCT03977272 — Combination of Anti-PD-1 Antibody and Chemotherapy in Metastatic Pancreatic Cancer · Phase 2 · completed

Other recruiting trials for Recurrent Rectal Cancer

Currently open trials in the same condition.

NCT05628038 — The Combination of Hypofractionated Radiotherapy and Immunotherapy in Locally Recurrent Rectal Cancer · Phase 2 · recruiting

Other Catharina Ziekenhuis Eindhoven trials

Trials by the same sponsor.

NCT07314138 — Multivessel Minimally Invasive Coronary Bypass Grafting as HYBRID Revascularization Versus Conventional Off-pump Coronar · NA · not yet recruiting
NCT06768060 — Mindfulness-based Intervention Prior to External Cephalic Version · NA · recruiting
NCT06574867 — Evaluation of the viQtor Monitoring Solution on Surgical Wards · recruiting
NCT06374836 — The Contractile Response of the Thoracic Aorta to Vasoactive Substances · completed
NCT06401291 — Transcutaneous Electrical Nerve Stimulation in Patients With Angina and Non-Obstructive Coronary Arteries · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04389086 (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 Catharina Ziekenhuis Eindhoven
Last refreshed: 6 September 2022

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/NCT04389086.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing