RecruitingPhase 1NCT04677413

Ultra-fractionated Radiotherapy for Rectal Cancer

Phase I Trial of Ultra-fractionated Adaptive Radiotherapy, Chemotherapy and Selective Omission of Surgery for Locally Advanced Rectal Cancer


Sponsor

University of Texas Southwestern Medical Center

Enrollment

27 participants

Start Date

Jun 3, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an ultra-fractionated radiation approach for rectal cancer — meaning the radiation is given in many small doses spread over a longer period of time, rather than in fewer larger doses. Researchers want to see if this approach is safer and equally effective at treating locally advanced rectal cancer. **You may be eligible if you:** - Are 18 years of age or older - Have been diagnosed with rectal adenocarcinoma (rectal cancer) - Have locally advanced disease (T3–T4 and/or lymph node involvement) - Have not received any prior treatment for rectal cancer - Are in adequate health (ECOG performance status 0–2) - Have acceptable blood counts and organ function **You may NOT be eligible if you:** - Have received prior treatment for rectal cancer - Have very poor organ or bone marrow function - Are not able to tolerate the proposed treatment plan Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONUltrafractionated radiotherapy for rectal cancer

To determine the toxicity of dose-escalated hypofractionated RT, in patients with locally advanced rectal cancer treated with RT, FOLFOX or CAPOX chemotherapy and selective omission of surgery.


Locations(1)

UT Southwestern Medical Center

Dallas, Texas, United States

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NCT04677413


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