Preoperative Sequential Short-course Radiation Therapy and FOLFOX for Locally Advanced Rectal Cancer
NCT ID: NCT05673772
Last Updated: 2025-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
364 participants
INTERVENTIONAL
2020-10-23
2029-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Short-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer
NCT01129700
A Trial of Neoadjuvant FOLFOX6 With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis
NCT01269229
Neoadjuvant FOLFOX6 Chemotherapy With or Without Radiation in Rectal Cancer
NCT01211210
Triplet Combination or Doublet Regimen Versus Chemoradiation as Neoadjuvant Therapy for Locally Advanced Rectal Cancer
NCT03975049
FOLFOX6 Totally Neoadjuvant Chemoradiation Therapy in Locally Advanced Rectal Cancer: A Real World Study
NCT02887313
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Study group
Short-course radiotherapy and 4 cycles of mFOLFOX6 followed by TME. Adjuvant chemotherapy will be given according to the pathological stage (CR\~pStageI: 6 cycles of capecitabine or 4 cycles of 5-FU with leucovorin, pStageII-III: 8 cycles of mFOLFOX6)
short-course radiotherapy
25 Gy in 5 fractions for 5 days
mFOLFOX6
Oxaliplatin 85 mg/m2, Levoleucovorin 200mg (or Leucovroin, Leucosodium 400mg)/m2, 5- FU 400 mg/m2, and continuous 5- FU 2,400 mg/m2 for 46 hours
TME surgery
TME surgery
Control group
Conventional chemoradiotherapy followed by TME. Adjuvant chemotherapy will be given according to the pathological stage (CR\~pStageI: 6 cycles of capecitabine or 4 cycles of 5-FU with leucovorin, pStageII-III: 8 cycles of mFOLFOX6)
Chemoradiotherapy
45\~50.4 Gy/25fr with concurrent use of either capecitabine or 5-FU+leucovorin(or levoleucovorin or leucosodium)
TME surgery
TME surgery
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
short-course radiotherapy
25 Gy in 5 fractions for 5 days
mFOLFOX6
Oxaliplatin 85 mg/m2, Levoleucovorin 200mg (or Leucovroin, Leucosodium 400mg)/m2, 5- FU 400 mg/m2, and continuous 5- FU 2,400 mg/m2 for 46 hours
Chemoradiotherapy
45\~50.4 Gy/25fr with concurrent use of either capecitabine or 5-FU+leucovorin(or levoleucovorin or leucosodium)
TME surgery
TME surgery
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* A person who understands the study and willing to provide informed consent
* 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
20 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Center, Korea
OTHER_GOV
Kyungpook National University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Gyu-Seog Choi
M.D., Ph.D
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gyu seog Choi
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Chonnam National University Hwasun Hospital
Gwangju, , South Korea
Catholic University of Korea Incheon St. Mary's Hospital
Incheon, , South Korea
Jeonbuk National University Hospital
Jeonju, , South Korea
Asan Medical Center
Seoul, , South Korea
, Korea University Anam Hospital
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Seoul National University Bundang Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Chang Hyun Kim, M.D.
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Kang MK, Park SY, Park JS, Kim HJ, Kim JG, Kang BW, Baek JH, Cho SH, Seo AN, Kim DW, Kim J, Baek SJ, Kim JH, Kim JY, Ha GW, Park EJ, Park IJ, Kim CH, Kang H, Choi GS. Preoperative sequential short-course radiation therapy and FOLFOX chemotherapy versus long-course chemoradiotherapy for locally advanced rectal cancer: a multicenter, randomized controlled trial (SOLAR trial). BMC Cancer. 2023 Nov 3;23(1):1059. doi: 10.1186/s12885-023-11363-7.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KNUHCRC007
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.