Clinical trial · Interventional
Study of Short Course Radiation Therapy for Elderly Patients With Rectal Cancer
Prospective Study of Short Course Radiation Therapy for Elderly Patients With Rectal Cancer
NCT04139967CI-TRIAL-00068026terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): recruitment rates were too low
Summary
Brief summary (as posted)
This study will help determine if a short course of radiation therapy is effective to treat rectal cancer in older patients. A shorter course of radiation treatment may be better tolerated than a longer course or surgery for the treatment of rectal cancer in the elderly.
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 |
|---|---|---|---|
| Cancer, Rectal | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Short course radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Elderly rectal cancer patients
- interventionNames
- Radiation: Short course radiation therapy
Primary outcomes (2)
- measure
- Progression-free survival
- timeFrame
- 5 years
- description
- Progression will be defined as Radiologic response from MRI or CT scans using RECIST v1.1 criteria.
- measure
- Number of participants who experience a grade 2 adverse event
- timeFrame
- week 5
- description
- CTCAE V4.0 will be used to determine the grade 2 AE.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 70 years or older at time of diagnosis * No restrictions on gender or ethnicity * Ability and willingness to make follow up appointments * Pathologic diagnosis of rectal cancer * Presentation could be symptomatic or asymptomatic * T1-T3 primary rectal adenocarcinoma as determined on TRUS, CT, or MRI pelvis * Peri-rectal node positive allowed * Inability to tolerate radical surgery, as judged by geriatric oncology or surgeon and tumor board OR patient refusal of surgery * Inability to receive chemoradiation therapy, defined as concurrent chemotherapy and radiation doses of 45-50.4 Gy, as judged by radiation, medical, or geriatric oncology * Patients with dementia eligible if Health Care Proxy (HCP) is available and supportive of follow up schedule Exclusion Criteria: * Age under 70 years of age * Ability and desire to receive definitive surgical intervention * Ability and desire to receive concurrent chemoradiation therapy
References
Publications (0)
Data not yet available
No reference posted for this study.