Clinical trial · Interventional
Rectal Cancer, Adjuvant Chemotherapy, FOLFOX(5-fluorouracil/Leucovorin/Oxaliplatin), Total Mesorectal Excision
Adjuvant Chemotherapy With FOLFOX After Total Mesorectal Excision for Locally Advanced Rectal Cancer; an Open-label, Multicenter, Prospective, Randomized Phase 3 Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The introduction of total mesorectal excision (TME) and the progress of neoadjuvant chemoradiotherapy has significantly reduced the risk of local recurrence in locally advanced rectal cancer. However, systemic recurrence rate is not being improved and that is considered as the cause of unsatisfactory overall survival of patients with rectal cancer. Relatively higher systemic relapse rate than local recurrence rate is probably due to the insufficient control of systemic micrometastasis during adjuvant chemotherapy. The efficacy of adjuvant combination cytotoxic chemotherapy after surgery in treatment of rectal cancer remains controversial. In addition, preoperative radiotherapy increases surgical complication such as anastomosis site leakage and radiotherapy itself worsen sexual and urinary function and bowel habit which result in aggravation of the quality of life. Furthermore the preoperative chemoradiotherapy upto 3 months not only extends treatment period but increases cost of care. To reduce the possibility of overtreatment, it is needed to confirm that the preoperative chemoradiotherapy is absolutely necessary to locally advanced rectal cancer patients with safe circumferential margin (CRM) resected curatively by standardized TME operation. In this study, investigators aim to evaluate the efficacy of adjuvant FOLFOX chemotherapy after TME without preoperative chemoradiotherapy in patients with locally advanced rectal cancer having spared CRM are not inferior to that of current standard treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arm A : standard neoadjuvant chemoradiotherapy group | Drug | — | UNRESOLVED |
| Arm B : adjuvant FOLFOX group | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A
- description
- Arm A; standard neoadjuvant chemoradiotherapy group fluoropyrimidine based concurrent chemoradiotherapy-\> TME -\> adjuvant chemotherapy (Low risk: fluoropyrimidine-based chemotherapy, High risk: FOLFOX)
- interventionNames
- Drug: Arm A : standard neoadjuvant chemoradiotherapy group
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Arm B : adjuvant FOLFOX group Total mesorectal excision (TME) --\> 12 cycles of FOLFOX every 2 weeks (or Total mesorectal excision (TME) --\> Concurrent chemoradiotherapy + 12 cycles of FOLFOX every 2 weeks)
- interventionNames
- Drug: Arm B : adjuvant FOLFOX group
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the rectum below 10 cm from the anal verge 2. Locally advanced rectal cancer (T3N0 or T1-3N+) 3. Age: 19-80 years old. 4. Without evidence of distant metastasis including paraortic lymph node, common \& external iliac lymph node metastasis 5. MRI scan confirmed more than 2 mm circumferential margin 6. ECOG(Eastern Cooperative Oncology Group) performance status 0-2 7. preoperative ASA class I-III 8. No prior systemic treatment for rectal cancer (i.e. chemotherapy or immunotherapy) 9. No history of regional radiation treatment in the pelvic cavity 10. Adequate hematologic function: ANC(absolute neutrophil count) ≥ 1.5×109/L,Platelet ≥ 100×109/L, Adequate renal function: Cr ≤ 1.5×ULN or Glomerular filtration rate (Ccr calculated by Cockcroft formula) ≥ 50 ml/min, Adequate hepatic function: ALT(Alanine aminotransferase)/AST(aspartate aminotransferase) ≤ 2.5×ULN, Total bilirubin ≤ 1.5×ULN 11. Patients must be willing and able to comply with the protocol duration of the study 12. Signed informed consent Exclusion Criteria: 1. Malignancy of the rectum other than adenocarcinoma or adenocarcinoma developed from inflammatory bowel disease 2. Suspicious distant metastasis 3. Patients with peripheral neuropathy ≥ NCI CTC(common terminology criteria) grade 1 4. Uncontrolled and significant cardiovascular disease (i.e. NYHA(New York Heart Association) class III or IV heart failure, myocardial infarction within the past 6 months, uncontrolled angina pectoris) 5. Uncontrolled active infection or serious concomitant systemic disorders incompatible with the study 6. Other co-existing malignancy or malignancy within the past 5 years, with the exception of adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin 7. Patients requiring immunosuppressive treatment who received organ transplantation 8. Uncontrolled epilepsy and psychiatric disease 9. Pregnant or lactating patient 10. Females with a positive or no pregnancy test unless childbearing potential can be otherwise excluded (amenorrheic for at least 2 years,hysterectomy or oophorectomy) 11. Patients receiving a concomitant treatment with drugs interacting with 5-Fluorouracil or oxaliplatin such as flucytosine, phenytoin, or warfarin 12. Prior unanticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to 5-Fluorouracil or known dihydropyrimidine dehydrogenase (DPD) deficiency. 13. Known hypersensitivity to platinum-based drugs, leucovorin or capecitabine 14. Patients taking sorivudine or brivudine 15. Patients taking tegafur, gimeracil, oteracil potassium complex or stopped the medication within 7days before. 16. Patients who have hereditary disease like as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, etc. 17. Participant in any clinical trial within 4 weeks before initiation of the study 18. Treatment with bevacizumab, cetuximab, oxaliplatin or irinotecan before screening
References
Publications (1)
- DERIVEDLee JB, Kim HS, Jung I, Shin SJ, Beom SH, Chang JS, Koom WS, Kim TI, Hur H, Min BS, Kim NK, Park S, Jeong SY, Baek JH, Kim SH, Lim JS, Lee KY, Ahn JB. Upfront radical surgery with total mesorectal excision followed by adjuvant FOLFOX chemotherapy for locally advanced rectal cancer (TME-FOLFOX): an open-label, multicenter, phase II randomized controlled trial. Trials. 2020 Apr 7;21(1):320. doi: 10.1186/s13063-020-04266-6. PMID 32264919