NCT04703101RecruitingPhase 1
Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of 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
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 7 Jan 2021
- Start date
- 11 Feb 2021
- Primary completion date
- 1 Oct 2026
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Diseases
- Colorectal cancer
- NCT number
- NCT04703101
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 25
- From 11 Feb 2021 to the primary completion date, 1 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Other illness
- 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
Other
- Pregnant and/or breastfeeding
- Medical/psychological contraindication to MRI
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.