Clinical trial · Interventional
A Study of Neoadjuvant Chemoradiotherapy With 5-FU/Leucovorin (FL) vs. TS-1/Irinotecan in Patients With Locally Advanced Rectal Cancer
A Randomized Phase II Study of Neoadjuvant Chemoradiotherapy With 5-FU/Leucovorin (FL) vs. TS-1/Irinotecan in Patients With Locally Advanced Rectal Cancer
- 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)
This is an open-label, randomized phase II study. Patients will be randomly assigned to either FL or TS-1/irinotecan preoperative chemotherapy regimens by stratification. Patients in FL group will be treated with bolus injections of 5-FU 400 mg/m2/day and LV 20 mg/m2/day for 3 consecutive days every 4 weeks for 2 cycles, and patients in TS-1/irinotecan will be treated with irinotecan 40 mg/m2/day on days 1, 8, 15, 22, 29. TS-1 at a dose of 35mg/m2 was administered orally twice a day after a meal on the day of irradiation (Monday-Friday) concurrent with radiotherapy.
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 |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU with leucovorin | Drug | — | UNRESOLVED |
| TS-1 with Irinotecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 5-FU with leucovorin
- interventionNames
- Drug: 5-FU with leucovorin
- type
- ACTIVE_COMPARATOR
- label
- TS-1 with Irinotecan
- interventionNames
- Drug: TS-1 with Irinotecan
Primary outcomes (1)
- measure
- pathologic complete response rate
- timeFrame
- every 4 weeks in FL group, every 2 weeks in TS-1/irinotecan group
- description
- To evaluate pathologic complete response rate in patients with resectable rectal cancer teated with neoadjuvant chemoradiotherapy with 5-FU/leucovorin (FL) vs. TS-1/Irinotecan and surgery followed by fluoropyrimidine based adjuvant chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the rectum * AJCC/UICC pathologic stages of cT3-4 or cN plus * Male or female patients, 18 years of age or older * Be ambulatory and have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * No prior chemotherapy, radiotherapy and immunotherapy * Adequate major organ functions as following: Hematopoietic function: ANC (absolute neutrophil count)1,500/mm3, Platelet 100,000/mm3, and Hepatic function: serum bilirubin \< 1.5 x ULN, AST/ALT levels \< 2.5 x ULN, and Renal function: serum creatinine \< 1.5 x ULN or Ccr 50 ml/min by Cockcroft formula * Be willing and able to comply with the protocol for the duration of the study. * Give written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice. Exclusion Criteria: * Any histologic feature other than adenocarcinoma or arisen from chronic inflammatory bowel disease * Patients treated with previous surgery, chemotherapy and/or radiotherapy * Uncontrolled or severe cardiovascular disease: New York Heart Association class III or IV heart disease, and Unstable angina or myocardial infarction within the past 6 months, and History of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality. * Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy. * Other malignancy within the past 5 years except non-melanomatous skin cancer or carcinoma in situ of the cervix. * Organ allografts requiring immunosuppressive therapy. * Psychiatric disorder or uncontrolled seizure that would preclude compliance. * Pregnant, nursing women or patients with reproductive potential without contraception. * Patients receiving a concomitant treatment with drugs interacting with 5-FU or irinotecan such as flucytosine, phenytoin, or warfarin et al. * Prior unanticipated severe reaction to fluoropyrimidine therapy, or known dihydropyrimidine dehydrogenase (DPD) deficiency. * Known hypersensitivity to any of the components of the study medications. * Received any investigational drug or agent within 4 weeks before beginning treatment with study drug.
References
Publications (0)
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