NCT06205485 (NEO-RT) is a Phase 3 clinical trial of Leucovorin in Rectal Cancer, sponsored by Canadian Cancer Trials Group.

Who is sponsoring NCT06205485?

NCT06205485 is sponsored by Canadian Cancer Trials Group.

What drugs are being tested in NCT06205485?

Interventions in NCT06205485: Leucovorin, Oxaliplatin, Fluoruracil, Capecitabine, Radiation.

What condition does NCT06205485 study?

NCT06205485 studies Rectal Cancer.

Is NCT06205485 still recruiting?

NCT06205485 is currently recruiting now. Last updated 14 April 2026.

Last reviewed 2026-04-14 · How we verify

NCT06205485: NEO-RT

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

Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer

Recruiting now Phase 3 Last updated 14 April 2026

What this trial tests

Phase 3 trial testing Leucovorin in Rectal Cancer in 250 participants. Currently enrolling.

Timeline

26 June 2024

Primary endpoint
30 January 2030

30 June 2030

Quick facts

Lead sponsor	Canadian Cancer Trials Group
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	250
Start date	26 June 2024
Primary completion	30 January 2030
Estimated completion	30 June 2030
Sites	105 locations across Canada, United States

Drugs / interventions tested

Leucovorin (leucovorin) — full drug profile →
Oxaliplatin (Oxaliplatin) — full drug profile →
Fluoruracil
Capecitabine (capecitabine) — full drug profile →
Radiation

Conditions studied

Rectal Cancer — all drugs for Rectal Cancer →

Sponsor

Canadian Cancer Trials Group — full company profile →

Who can join

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

Sponsor's own description

This study is being done to answer the following questions: Is the chance of rectal cancer responding the same if chemotherapy alone is given before limited surgery compared to chemotherapy and radiation therapy given together before limited surgery? If radiation therapy is not given, is quality of life better?

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Assessing the OPRA Trial for surgical oncologists: Safety and feasibility of a total neoadjuvant therapy approach in patients with rectal cancer.
Zambare W, Miranda J, Horvat N, Smith JJ. · · 2024 · cited 2× · PMID 41306768 · DOI 10.1016/j.soi.2024.100043

Verify or expand the search:

Other trials of Leucovorin

Trials testing the same drug.

NCT07415031 — A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies · Phase 2 · not yet recruiting
NCT07290985 — AACR Adaptive Biomarker-Driven Organ Preservation Trial in Gastroesophageal Adenocarcinomas · Phase 2 · not yet recruiting
NCT07474727 — A Phase II Study of AMT-676 Combination Therapies in Advanced Colorectal Cancer · Phase 2 · not yet recruiting
NCT07059611 — Neoadjuvant Intra-tumoral RP2 and FLOT in Gastroesophageal Adenocarcinoma · Phase 2 · not yet recruiting
NCT07409272 — A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherap · Phase 3 · recruiting

Other recruiting trials for Rectal Cancer

Currently open trials in the same condition.

NCT07528209 — Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer · Phase 3 · recruiting
NCT07537998 — Antegrade Intestinal Fluid Reinfusion for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a · Phase 2, PHASE3 · recruiting
NCT07501845 — Registry Maastro Applicator · recruiting
NCT07369531 — The Impact of Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis on Stoma-free Survival in Low Rectal Anal-pres · NA · recruiting
NCT07505472 — Efficacy and Safety Comparison of Short-course Radiotherapy Followed by CapeOX Chemotherapy Plus Toripalimab With or Wit · Phase 2, PHASE3 · recruiting

Other Canadian Cancer Trials Group trials

Trials by the same sponsor.

NCT07390435 — Feasibility and Acceptability of Collecting Sociodemographic Data in CCTG Trials · not yet recruiting
NCT07297667 — GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Relapsed/Refractory GPNMB-Expressing Solid Tumours · Phase 1 · not yet recruiting
NCT06630273 — Canadian Initiative to Measure, Predict and Assess Cancer Treatment Outcomes in Patients Treated With Immuno-Oncotherape · not yet recruiting
NCT07152821 — Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcino · Phase 3 · recruiting
NCT07341191 — Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR · Phase 2 · not yet 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 NCT06205485 (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 Canadian Cancer Trials Group
Last refreshed: 14 April 2026

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/NCT06205485.

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