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NCT04864067: NOAHS-ARC
No Operation After Short Course Radiotherapy Followed By Consolidation Chemotherapy In Locally Advanced Rectal Cancer
Phase 2 trial testing Oxaliplatin in Rectal Cancer in 73 participants. Participants enrolled and being followed up; not accepting new ones.
1 December 2025
Quick facts
| Lead sponsor | Servicio de Salud Metropolitano Sur Oriente |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 73 |
| Start date | 9 June 2021 |
| Primary completion | 1 December 2025 |
| Estimated completion | 1 March 2026 |
| Sites | 3 locations across Chile |
Drugs / interventions tested
- Oxaliplatin (Oxaliplatin) — full drug profile →
- 5-Fluoracil
- Leucovorin (leucovorin) — full drug profile →
- Capecitabine (capecitabine) — full drug profile →
- 5x5 Gy
- Quality of Life Questionnaires
- DRE/ Endoscopy
Conditions studied
- Rectal Cancer — all drugs for Rectal Cancer →
Sponsor
Servicio de Salud Metropolitano Sur Oriente — 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 designed to explore the hypothesis that in patients with a Locally advanced rectal cancer (LARC) treated with a Total neoadjuvant therapy (TNT) strategy based on short course radiotherapy (5x5Gy) followed by neoadjuvant consolidation chemotherapy is associated with a higher rate of pathological clinical response and sustained (\>1year) complete clinical response when compared to an historical cohort treated with long course chemoradiation therapy (CRT), total mesorectal excision (TME) and adjuvant chemotherapy (ACT).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
No operation after short-course radiotherapy followed by consolidation chemotherapy in locally advanced rectal cancer (NOAHS-ARC): study protocol for a prospective, phase II trial.
Quezada-Díaz FF, Bercz A, Escobar JL, Caire N, et al · · 2025 · cited 1× · PMID 40100473 · DOI 10.1007/s00384-025-04850-9 -
No Operation After Short-Course Radiotherapy Followed By Consolidation Chemotherapy in Locally Advanced Rectal Cancer (NOAHS-ARC): Study Protocol for a Prospective, Phase II Trial
Quezada-Díaz FF, Bercz A, Romesser PB, Escobar JL, et al · · 2024 · DOI 10.21203/rs.3.rs-4713792/v1
Verify or expand the search:
- PubMed search for NCT04864067
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Oxaliplatin
Trials testing the same drug.
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- NCT07469306 — Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer · Phase 2 · not yet recruiting
- 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
- NCT07340567 — Personalizing Chemotherapy Selection After Surgery for Patients With Stage III Colorectal Cancer Using a Blood Test · Phase 3 · not yet 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
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 NCT04864067 (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 Servicio de Salud Metropolitano Sur Oriente
- Last refreshed: 1 July 2025
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/NCT04864067.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing