Combination Chemotherapy + Radiation for Rectal Cancer
Trial Summary
What is the purpose of this trial?
This phase I trial investigates how well short-course radiation therapy followed by combination chemotherapy works in treating patients with stage II-III rectal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as leucovorin, fluorouracil, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving short-course radiation therapy and combination chemotherapy may reduce the need for surgery and therefore improve quality of life.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What evidence supports the effectiveness of the drug combination of Capecitabine, Xeloda, Fluorouracil, and Oxaliplatin with radiation for rectal cancer?
Is the combination of chemotherapy and radiation for rectal cancer safe for humans?
The combination of chemotherapy drugs like capecitabine (Xeloda) and 5-fluorouracil (5-FU) with radiation therapy has been shown to have a favorable safety profile in treating rectal cancer. Common side effects include hand-foot syndrome and mild, reversible leukopenia (low white blood cell count), but severe diarrhea is not common. These treatments have been well-tolerated in clinical trials, making them a generally safe option for patients.15678
What makes this treatment for rectal cancer unique?
This treatment combines chemotherapy drugs like capecitabine and oxaliplatin with advanced radiation therapy (Intensity-Modulated Radiation Therapy) to potentially improve outcomes by reducing tumor size before surgery. The combination aims to enhance the effectiveness of radiation and chemotherapy, offering a promising alternative to traditional treatments.123910
Research Team
Ann Raldow, MD
Principal Investigator
UCLA / Jonsson Comprehensive Cancer Center
Eligibility Criteria
This trial is for adults with stage II-III rectal adenocarcinoma confirmed by lab tests, without metastatic disease. They should be in good enough health to perform daily activities (KPS >= 70 or ECOG 0-2) and have normal blood counts and liver function tests. Pregnant or breastfeeding individuals, those with other active cancers, prior radiation in the same area, or conditions preventing MRI are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Participants undergo short-course radiation therapy in the form of intensity-modulated radiation therapy (IMRT) over 5 fractions daily for 5 consecutive days
Chemotherapy
Participants receive either mFOLFOX6 or CapeOX chemotherapy regimens. mFOLFOX6 is administered every 2 weeks for up to 8 cycles, and CapeOX is administered every 3 weeks for up to 6 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment. NOM patients are followed up every 3 months for 2 years, then every 6 months for 3 years. TME patients are followed up every 3-6 months for 2 years, then every 6 months for 3 years
Treatment Details
Interventions
- Capecitabine
- Fluorouracil
- Intensity-Modulated Radiation Therapy
- Leucovorin
- Oxaliplatin
- Total Mesorectal Excision
Capecitabine is already approved in European Union, United States, Canada, Japan for the following indications:
- Colorectal cancer
- Breast cancer
- Colorectal cancer
- Breast cancer
- Colorectal cancer
- Breast cancer
- Colorectal cancer
- Breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jonsson Comprehensive Cancer Center
Lead Sponsor
The Joseph Drown Foundation
Collaborator
Natera, Inc.
Industry Sponsor