Short course radiation therapy combined with chemotherapy for stage II-III rectal cancer
Organ Preservation for Patients With Locally Advanced Rectal Adenocarcinoma: Evaluating the Efficacy of Short Course Radiation Therapy Followed by FOLFOX or CapeOX
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 |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jonsson Comprehensive Cancer Center Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04703101 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed stage II or III rectal adenocarcinoma who have no evidence of metastatic disease.
Not a fit: Patients with distant metastatic disease or those undergoing active treatment for another malignancy may not benefit from this study.
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 performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
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 this trial is running
Los Angeles, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.