Short-course radiation therapy combined with FOLFOX for advanced rectal cancer
A Multicenter, Randomized Controlled Trial of Preoperative Sequential Short-course Radiation Therapy and Oxaliplatin-based Consolidation Chemotherapy for Locally Advanced Rectal Cancer
This study is testing a new treatment that combines short radiation therapy with chemotherapy to see if it helps people with advanced rectal cancer do better than with the usual treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 364 (estimated) |
| Ages | 20 Years to 75 Years |
| Sex | All |
| Sponsor | Kyungpook National University Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 9 sites (Daegu and 8 other locations) |
| Trial ID | NCT05673772 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a preoperative treatment regimen that combines short-course radiation therapy with four cycles of FOLFOX chemotherapy for patients with locally advanced rectal cancer. The aim is to shorten the radiation therapy duration while improving cure rates by addressing micrometastasis early with systemic chemotherapy. Participants will be randomly assigned to receive either the proposed treatment or conventional chemoradiotherapy, followed by total mesorectal excision surgery. The study seeks to determine if this innovative approach can enhance patient outcomes compared to standard treatment.
Who should consider this trial
Good fit: Ideal candidates include Asian patients with pathologically confirmed locally advanced rectal cancer and an ECOG performance status of 0-2.
Not a fit: Patients with colon cancer or rectal cancer located more than 10 cm from the anal verge may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to improved cure rates and better outcomes for patients with locally advanced rectal cancer.
How similar studies have performed: Other studies have shown promise with similar neoadjuvant approaches, suggesting potential for success in this novel treatment strategy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Asian * ECOG (Eastern Cooperative Oncology Group) performance status 0-2 * Pathologically confirmed rectal cancer (rectal cancer located 10 cm or low from the anal verge in pelvis MRI) * Histologic type: adenocarcinoma, mucinous carcinoma, and signet ring cell carcinoma * Locally advanced rectal cancer with one or more of the following factors based on pelvis MRI: cTanyN1-2, cT3-4N0, or presence of extramural vascular invasion * MRI findings such as pelvic lymph node metastasis, anal sphincter invasion, and T4b are not included in the exclusion criteria, which cases will be enrolled by the researcher's discretion * Patients with appropriate organ (bone marrow, kidney, liver) function * A person who understands the study and willing to provide informed consent Exclusion Criteria: (one of the following criteria) * Colon cancer or rectal cancer located more than 10 cm from the anal verge * Stage I rectal cancer (clinical stage cT1-2N0) * Clinically or pathologically diagnosed distant metastasis (cTanyNanyM1) * Familial adenomatous polyposis * Hereditary nonpolyposis colorectal cancer * History of chemotherapy or radiotherapy within 6 months * History of colorectal cancer or other type of malignancy within 5 years (except for cured nonmelanoma skin or in situ cervical cancer) * Comorbidities that make it difficult to undergo chemotherapy or radiotherapy * Bone marrow suppression with neutrophil count \<2 ×109/L or platelet count \<100 ×109/L prior to the first chemotherapy * Peripheral sensory neuropathy with functional impairment (grade 2 or higher) * Severe renal dysfunction (GFR ≤30ml/min by Wright or Cockroft formula) * Severe hepatic dysfunction * Genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption * Taking tegafur, gimeracil, and oteracil potassium complex and those within 7 days of discontinuation * Taking sorivudine or brivudine * Significant heart disease or myocardial infarction within the last 6 months * Hereditary diseases or history of coagulopathy * Central nervous system disorders with disability or mental disorders * Pregnant or lactating women * Currently participating in other clinical trials or receiving research medication * Unhealed wounds, fractures, peptic ulcer, abscesses in the abdominal cavity * Active gastrointestinal bleeding * Active infections requiring antibiotics for injection * Emergency Surgery * History of hypersensitivity to the drugs in study protocol * Patients with non-malignant tumor diseases * Dihydropyrimidine dehydrogenase deficiency * Not willing to participate
Where this trial is running
Daegu and 8 other locations
- Gyu seog Choi — Daegu, Korea, Republic of (Recruiting)
- Chungnam National University Hospital — Daejeon, Korea, Republic of (Recruiting)
- Chonnam National University Hwasun Hospital — Gwangju, Korea, Republic of (Recruiting)
- Catholic University of Korea Incheon St. Mary's Hospital — Incheon, Korea, Republic of (Recruiting)
- Jeonbuk National University Hospital — Jeonju, Korea, Republic of (Recruiting)
- Asan Medical Center — Seoul, Korea, Republic of (Recruiting)
- , Korea University Anam Hospital — Seoul, Korea, Republic of (Recruiting)
- Gangnam Severance Hospital — Seoul, Korea, Republic of (Recruiting)
- Seoul National University Bundang Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Soo Yeun Park, M.D.
- Email: psy-flower@daum.net
- Phone: +82-53-200-3867
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.