Short course radiotherapy followed by chemotherapy for 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
This study is testing if giving short radiation followed by chemotherapy helps people with locally advanced rectal cancer have better treatment results than older methods.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 73 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Servicio de Salud Metropolitano Sur Oriente Government |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Santiago, RM and 2 other locations) |
| Trial ID | NCT04864067 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a total neoadjuvant therapy (TNT) approach in patients with locally advanced rectal cancer (LARC) by administering short course radiotherapy followed by consolidation chemotherapy. The aim is to determine if this strategy leads to higher rates of pathological complete response (pCR) and sustained complete clinical response (cCR) compared to historical treatment methods. The study will evaluate treatment compliance, toxicity, and response rates in both surgically managed and non-operative patients. By comparing outcomes with historical cohorts, the research seeks to establish a standardized TNT model for improved patient management.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed adenocarcinoma of the rectum, clinical stage II or III, and tumors less than 7cm from the anal verge.
Not a fit: Patients with stage IV rectal cancer or those with contraindications to chemotherapy or MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better treatment outcomes and organ preservation for patients with locally advanced rectal cancer.
How similar studies have performed: Previous studies have shown promising results with total neoadjuvant therapy approaches, indicating potential success for this novel strategy.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Santiago, RM and 2 other locations
- Complejo Asistencial Doctor Sótero del Rio — Santiago, Rm, Chile (Recruiting)
- Hospital La Florida — Santiago, Rm, Chile (Recruiting)
- Hospital Padre Hurtado — Santiago, Rm, Chile (Recruiting)
Study contacts
- Principal investigator: Felipe F Quezada-Diaz, MD — Complejo Asistencial Doctor Sótero del Rio
- Study coordinator: Felipe F Quezada-Diaz, MD
- Email: ffquezad@gmail.com
- Phone: + 562 25762401
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.