Short course radiation therapy combined with chemotherapy for stage II-III rectal cancer
Official title: Organ Preservation for Patients With Locally Advanced Rectal Adenocarcinoma: Evaluating the Efficacy of Short Course Radiation Therapy Followed by FOLFOX or CapeOX
Run by Jonsson Comprehensive Cancer Center · NCT04703101 · Data updated 2026-11-12
This study is testing a new treatment plan that combines short radiation therapy with chemotherapy to see if it helps people with stage II-III rectal cancer feel better and have fewer problems after treatment.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | Jonsson Comprehensive Cancer Center Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Los Angeles, California) |
| Status | Recruiting |
| Started | February 11, 2021 |
| Main results expected | July 3, 2025 |
| Study ends | October 15, 2027 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT04703101 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with histologically confirmed stage II or III rectal adenocarcinoma who have no evidence of metastatic disease.
✕Probably not a fit
Patients with distant metastatic disease or those undergoing active treatment for another malignancy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase I trial evaluates the effectiveness of short-course radiation therapy followed by a combination of chemotherapy drugs in treating patients with stage II-III rectal cancer. The approach involves administering intensity-modulated radiation therapy over five days, followed by a regimen of modified leucovorin, fluorouracil, and oxaliplatin or capecitabine and oxaliplatin. The study aims to assess the complete clinical response rate, local recurrence-free survival, and patient-reported outcomes related to quality of life and anorectal function. Additionally, it explores the correlation between residual disease tests and treatment outcomes.
Why it matters
Potential benefit: If successful, this treatment could reduce the need for surgery and improve the quality of life for patients with rectal cancer.
How similar studies have gone: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed rectal adenocarcinoma * Patients must have stage II (cT3, cN0) or stage III (cT1-3, cN1-3) tumor as staged by MRI * No evidence of metastatic disease * Resectable primary lesion * Karnofsky performance status (KPS) \>= 70 or Eastern Cooperative Oncology Group (ECOG) 0-2 * Absolute neutrophil count (ANC) \> 1.5 cell/mm\^3 * Hemoglobin (Hgb) \> 8.0 gm/dL * Platelets (PLT) \> 150,000/mm\^3 * Total bilirubin \< or equal to 1.5 x upper limit of normal * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< or equal to three times upper limit of normal * If a woman is of childbearing potential, a negative serum pregnancy test must be documented prior to initiation of radiation therapy Exclusion Criteria: * Active treatment of a separate malignancy * Distant metastatic disease as assessed by staging positron emission tomography (PET)/computed tomography (CT) or CT of the chest and abdomen within 6 weeks of starting radiation therapy * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields * Pregnant and/or breastfeeding * Medical/psychological contraindication to MRI
Where it's running
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UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States Recruiting
Study contacts
- Principal investigator: Ann Raldow — UCLA / Jonsson Comprehensive Cancer Center
- Study coordinator: Vincent Basehart
- Email: vbasehart@mednet.ucla.edu
- Phone: 310 267-8954
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Using blood tests to improve treatment strategies for rectal cancer
This study is testing if measuring tumor DNA in the blood can help doctors see how well treatments are working for people with stage II-III rectal cancer.
-
Monitoring and chemotherapy before surgery for stage II-III rectal cancer
This study tests if monitoring and chemotherapy before surgery can help people with stage II-III rectal cancer keep their organs and improve their treatment choices.
-
Evaluating quality of life after surgery for rectal cancer
This study looks at how surgery for rectal cancer affects the quality of life for patients over time, comparing those who received radiation therapy to those who didn’t.
-
Neoadjuvant Botensilimab and Balstilimab for Advanced Resectable Colorectal Cancer
This phase 2 trial tests whether giving botensilimab and balstilimab before surgery can help patients with advanced, resectable colorectal cancer see better outcomes.
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Family genetics: who shares test results with relatives
This study tests whether letting patients share genetic results with their relatives is as good as doctors sharing the results to help first-degree relatives get genetic testing for hereditary cancer risk.
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Neoadjuvant FOLFOX with botensilimab and balstilimab for localized rectal cancer
This test tries whether giving FOLFOX chemotherapy together with the immune drugs botensilimab and balstilimab before surgery helps people with localized rectal cancer achieve a complete clinical response.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.