Clinical trial · Interventional
No Operation After Short Course Radiotherapy Followed By Consolidation Chemotherapy In Locally Advanced Rectal Cancer
No Operation After Short Course Equivalent Dose (Ht) Radiation Therapy Followed By Consolidation Chemotherapy In Locally Advanced Rectal Cancer: The Prospective, Single Arm NOAHS-ARC Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluoracil | Drug | — | UNRESOLVED |
| 5x5 Gy | Radiation | — | UNRESOLVED |
| Capecitabine | Drug | Capecitabine | ALIAS |
| DRE/ Endoscopy | Procedure | — | UNRESOLVED |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Quality of Life Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Short Course Radiotherapy and Consolidation Chemotherapy
- description
- This arm will receive short course radiotherapy (5x5 Gy) during 1 week. Between 7 to 14 days after radiotherapy, patient will receive 9 cycles of FOLFOX. CapeOX may be given as alternative for FOLFOX.
- interventionNames
- Drug: Oxaliplatin
- Drug: 5-Fluoracil
- Drug: Leucovorin
- Drug: Capecitabine
- Radiation: 5x5 Gy
- Behavioral: Quality of Life Questionnaires
- Procedure: DRE/ Endoscopy
Primary outcomes (2)
- measure
- Rate of pathological and sustained clinical response
- timeFrame
- 3 years
- description
- Combined number of patients with pathological response in the surgical specimen and patients in a Watch and Wait protocol with a sustained clinical response longer than a year.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of adenocarcinoma of the rectum * Clinical Stage II (T3-4, N-) or Stage III (any T, N+) based on Magnetic Resonance Imaging (MRI) * Tumors \< 7cm from anal verge (palpable) * No prior history of rectal cancer Exclusion Criteria * Patients with tumors \>7cm from anal verge * ECOG \>1, * Contraindication for chemotherapy: Hemoglobin \<8, White Blood Count \<4000, Platelets \<100,000, Creatinine Clearance \<50ml/min, Total Bilirubin \<5mg/dl, * Stage IV at diagnosis * Coronary artery disease, either no treated or recent acute coronary syndrome in the last 12 months. * Congestive heart failure * Peripheral neuropathy * Previous pelvic radiotherapy * Prior rectal cancer treatment * Pregnancy or nursery * Any contraindications to MRI (e.g. patients with pacemakers) * Indication of pelvic exenteration * Impossibility to consent.
References
Publications (1)
- DERIVEDQuezada-Diaz FF, Bercz A, Escobar JL, Caire N, Diaz-Feldman LE, Manriquez E, Carvajal G. 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. Int J Colorectal Dis. 2025 Mar 18;40(1):69. doi: 10.1007/s00384-025-04850-9. PMID 40100473