NCT04864067CompletedPhase 2
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 · Last updated 8 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 39 (actual)
- First submitted
- 25 Apr 2021
- Start date
- 9 Jun 2021
- Primary completion date
- 5 May 2026
- Lead sponsor
- Servicio de Salud Metropolitano Sur Oriente
- Diseases
- Colorectal cancer
- NCT number
- NCT04864067
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 39
- From 9 Jun 2021 to the primary completion date, 5 May 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous pelvic radiotherapy
- Prior rectal cancer treatment
Other illness
- Coronary artery disease, either no treated or recent acute coronary syndrome in the last 12 months.
- Congestive heart failure
Lab values
- Contraindication for chemotherapy: Hemoglobin \<8, White Blood Count \<4000, Platelets \<100,000, Creatinine Clearance \<50ml/min, Total Bilirubin \<5mg/dl,
Other
- Patients with tumors \>7cm from anal verge
- ECOG \>1,
- Stage IV at diagnosis
- Peripheral neuropathy
- Pregnancy or nursery
- Any contraindications to MRI (e.g. patients with pacemakers)
- Indication of pelvic exenteration
- Impossibility to consent.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Padre Hurtado Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Hospital La Florida Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Complejo Asistencial Doctor Sótero del Rio Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.