Clinical trial · Interventional
Intensity Modulated Radiation Therapy (IMRT) for Patients With Rectal Cancer
A Phase II Study of Neoadjuvant Short Course Intensity Modulated Radiation Therapy (IMRT) for Patients With Rectal Cancer: An Analysis of Quality of Life and Biomarkers of Response
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was closed to enrollment due to slow accrual.
Summary
Brief summary (as posted)
This study will investigate short course radiation therapy using IMRT as an alternative to standard chemo radiation because prior studies have shown that this method of treatment will potentially reduce some fo the side effects of standard treatment, improve quality of life, and help to control the growth of rectal cancer cells. IMRT is a type of radiation that uses computer-generated images to match radiation to the size and shape of the tumor. Since the intensity of each radiation beam can be controlled, the radiation dose can wrap around normal tissue which allows the study doctor to deliver a higher dose of radiation to the tumor with less damage to nearby healthy tissue. The purpose of this research study is to see what impact this treatment will have on quality of life, as well as to see if there are any late side effects that come about after the participant has completed the treatment.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensity Modulated Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Short course IMRT
- description
- Patients will receive short course IMRT (Intensity Modulated Radiation Therapy) prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after
- interventionNames
- Radiation: Intensity Modulated Radiation Therapy
Primary outcomes (1)
- measure
- Bowel Quality of Life
- timeFrame
- 2 years
- description
- To determine the rate of fecal incontinence at 1 year in patients undergoing an low anterior resection (LAR), as measured by bowel quality of life measure after preoperative conformal radiation therapy delivered in one week for rectal cancer.
Secondary outcomes (5)
- measure
- Pelvic Control Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the rectum * T3 or N+ disease by MRI or endoscopic ultrasound. Metastatic disease is permitted, except for known brain metastases, as long as local treatment with RT and surgery is recommended. * Prior chemotherapy is permitted. For patients who have previously received bevacizumab, the last dose must be greater than 4 weeks prior to initiation of radiation therapy. * 18 years of age or older * Life expectancy of greater than 3 months * ECOG (Eastern Cooperative Oncology Group) Performance Status of 0, 1 or 2 * Normal organ and marrow function as outlined in the protocol * Women of child-bearing potential and men must agree to use of adequate contraception prior to study entry and for the duration of study participation Exclusion Criteria: * Pelvic radiotherapy prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier * Participants may not be receiving any other investigational agents. Patients may not be receiving any other treatment for their rectal cancer during study participation * Participants with known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events * History of known radiation sensitivity syndrome * History of inflammatory bowel disease * Active scleroderma or CREST syndrome * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or nursing women
References
Publications (0)
Data not yet available