Ultra-fractionated Radiotherapy for Rectal Cancer (NCT04677413)
Phase I Trial of Ultra-fractionated Adaptive Radiotherapy, Chemotherapy and Selective Omission of Surgery for Locally Advanced Rectal Cancer
🩺 Plain-English Summary (8th-Grade Level)
The rationale of this clinical trial is to assess the feasibility of selective non-operative management for locally advanced rectal cancer using dose-escalated ultra-fractionated short course radiation therapy interdigitated with chemotherapy. We believe delivering short course radiotherapy over a prolonged interval, at escalated doses and with concurrent chemotherapy may be feasible and allow for improved clinical response.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (16 items) and avoid the listed exclusions (6 items).
Location: UT Southwestern Medical Center — Dallas, Texas
Age range: 18 Years
🧪 Interventions in This Study
- Ultrafractionated radiotherapy for rectal cancer (RADIATION)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Distant nodal disease (retroperitoneal nodes) including inguinal nodes, or any metastatic disease by CT.
- Prior RT to the pelvis.
- Uncontrolled comorbid illness or condition including congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness that would limit compliance with the study requirements.
- Psychiatric illness/social situations that would limit consenting and compliance with study requirements.
- Participants who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- UT Southwestern Medical Center — Dallas, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Rectal Cancer
- Trial Evaluating 3-year Disease Free Survival in Patients With Locally Advanced Rectal Cancer Treated With Chemoradiation Plus Induction or Consolidation Chemotherapy and Total Mesorectal Excision or Non-operative Management — Irvine, California
- ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer — Boston, Massachusetts
- High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial) — Tampa, Florida
- Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer — Phoenix, Arizona
- Low Powered Colorectal Anastomosis After Rectal Excision (OASIS) — Leuven,
- A Phase I-II Study to Test the Safety and Efficacy of PD1 (AB122) and Adenosine Receptor (AB928) Antagonists With Chemotherapy After Short-Course Radiation for Rectal Cancer. — New York, New York
Explore by condition: All Rectal Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.