Actively Recruiting
Organ Preservation for Patients With Locally Advanced Rectal Adenocarcinoma: Evaluating the Efficacy of Short Course Radiation Therapy Followed by FOLFOX or CapeOX
Led by Jonsson Comprehensive Cancer Center · Updated on 2026-03-30
25
Participants Needed
1
Research Sites
54 weeks
Total Duration
On this page
Sponsors
J
Jonsson Comprehensive Cancer Center
Lead Sponsor
T
The Joseph Drown Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how well short-course radiation therapy followed by combination chemotherapy works in treating patients with stage II-III rectal cancer. This phase I trial focuses on using radiation to kill tumor cells and shrink tumors, along with chemotherapy drugs such as leucovorin, fluorouracil, oxaliplatin, and capecitabine that aim to stop tumor growth. The goal is to reduce the need for surgery and improve quality of life for patients with locally advanced rectal adenocarcinoma. Participants receive intensity-modulated radiation therapy (IMRT) over five consecutive days. Starting 11 to 18 days after radiation, they then receive combination chemotherapy with either mFOLFOX6 (oxaliplatin and leucovorin intravenously, fluorouracil intravenously) or CapeOX (oxaliplatin intravenously and oral capecitabine). Treatment cycles last up to 16 weeks, with mFOLFOX6 repeating every two weeks for up to eight cycles and CapeOX every three weeks for up to six cycles, depending on tolerance and disease progression. After treatment, patients with remaining tumor undergo total mesorectal excision (TME) surgery, while those with complete clinical response (cCR) follow a non-operative management (NOM) approach. During the study, patients are monitored through imaging, laboratory tests, and health-related quality of life assessments. Follow-up includes regular visits every three months for two years, then every six months for three years for NOM patients; TME patients have follow-ups every three to six months for two years, then every six months for three years. Researchers measure outcomes such as complete clinical response rates, local recurrence-free survival, progression-free survival, adverse events, anorectal function, and quality of life. They also explore predictive markers using MRI and residual disease tests to better understand treatment effects over up to five years.
CONDITIONS
Brief Title
Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed rectal adenocarcinoma
- 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) of 70 or higher, or Eastern Cooperative Oncology Group (ECOG) score 0-2
- Absolute neutrophil count (ANC) greater than 1.5 cells/mm^3
- Hemoglobin (Hgb) greater than 8.0 gm/dL
- Platelet count (PLT) greater than 150,000/mm^3
- Total bilirubin less than or equal to 1.5 times the upper limit of normal
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to three times the upper limit of normal
- Women of childbearing potential must have a negative serum pregnancy test before starting radiation therapy
You will not qualify if you...
- Active treatment for a different malignancy
- Distant metastatic disease as shown by recent PET or CT scans within 6 weeks before radiation therapy
- Previous radiotherapy to the cancer region that would overlap with study treatment
- Pregnant or breastfeeding
- Medical or psychological reasons preventing MRI scans
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 to 5 months
Participants receive short-course radiation therapy followed by combination chemotherapy with either mFOLFOX6 or CapeOX.
5 daily visits for radiation therapy, then chemotherapy cycles every 2 or 3 weeks for up to 8 cycles
Duration - Single surgery event
Participants with residual tumor undergo total mesorectal excision surgery 8 to 12 weeks after completion of all therapy.
1 surgical procedure
Duration - 5 years
Participants who achieve complete clinical response undergo non-operative management with regular follow-up visits.
Every 3 months for 2 years, then every 6 months for 3 years
Duration - 5 years
Participants who undergo surgery are monitored regularly for recurrence and health outcomes.
Every 3 to 6 months for 2 years, then every 6 months for 3 years
Trial Site Locations
Total: 1 location
1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
V
Vincent Basehart
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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