Clinical trial · Interventional
Totally Neoadjuvant FOLFOXIRI + Short-course Radiation + XELOX in Patients With Locally Advanced Rectal Cancer
Totally Neoadjuvant FOLFOXIRI Chemotherapy Followed by Short-course Radiation and XELOX Chemotherapy in Patients With Locally Advanced Rectal Cancer：an Open-label, Single-arm, Multicenter Phase II Study.
NCT03484221CI-TRIAL-00051263unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
To evaluate the efficacy and safety of totally neoadjuvant FOLFOXIRI chemotherapy (irinotecan, oxaliplatin and fluorouracil) followed by short-course radiation therapy and XELOX chemotherapy in the patients with locally advanced rectal cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Drug Therapy | — | UNRESOLVED | — |
| Radiation | — | UNRESOLVED | — |
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFOXIRI | Drug | — | UNRESOLVED |
| Short-Course Radiation Therapy(5Gy*5) | Radiation | — | UNRESOLVED |
| XELOX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FOLFOXIRI+short-course radiation+XELOX
- description
- Firstly, 4 cycles of neoadjuvant FOLFOXIRI chemotherapy were administered. Subsequently, a short-course radiation therapy (5Gy\*5) will be performed. After that, 4 cycles of XELOX chemotherapy will be administered followed by surgery.
- interventionNames
- Drug: FOLFOXIRI
- Radiation: Short-Course Radiation Therapy(5Gy*5)
- Drug: XELOX
Primary outcomes (1)
- measure
- The ratio of tumor downstaging to stage 0 and stage I
- timeFrame
- 2 years
- description
- Tumor downstaging from stage II or III to pathologic complete response (stage 0) and stage I
Secondary outcomes (7)
- measure
- Tumor regression grade (TRG)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 18-75 years old * Primary and pathological diagnosis of rectal adenocarcinoma * Radiographic evaluation of initial resectable rectal cancer * T staging was determined by MRI as T3N+ or T4Nx * Distal border of the tumor must be located \< 12 cm from the anal verge * ECOG status: 0～1 * Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: Neutrophil count≥1.5×10\^9/L Platelet count≥90×10\^9/L Hemoglobin≥90g/L Total bilirubin (TBI) ≤ 1.5 \* ULN Alanine aminotransferase (ALT)≤2.5 \* ULN Aspartate aminotransferase (AST)≤2.5 \* ULN Alkaline phosphatase (ALP)≤2.5 \* ULN \- Signed informed consent; able to comply with study and/or follow- up procedures Exclusion Criteria: * Previous treatment with oxaliplatin, irinotecan or fluorouracil * Hypersensitivity to fluorouracil, oxaliplatin or irinotecan. * Clear indication of involvement of the pelvic side walls by imaging * With distant metastasis * A history of malignant rectal cancer (i. e. sarcoma, lymphoma, carcinoid, squamous cell carcinoma) or synchronous colon cancer * Cardiovascular disease that would preclude study treatment or follow-up; New York Heart Association class III or IV heart disease; active ischemic heart disease; myocardial infarction within the past 6 months; symptomatic arrhythmia uncontrolled hypertension. Unexplained syncope occurred within 3 months * Digestive system diseases that would preclude study treatment or follow-up within the past 6 months * Gastric ulcers or duodenal ulcers for the treatment of resistance; * 3 or 4 grade gastrointestinal bleeding / bleeding; * Gastrointestinal perforation / fistula; * Abdominal abscess; * Infectious or inflammatory bowel disease * HIV infection and/or active hepatitis B virus infection * Pregnant or lactating women. Fertile patients must use effective contraception * Any serious acute or chronic disease that can not be involved in the study or to influence the interpretation of the results of the study * Other intervention clinical trials were combined at the same time. * Nerve or mental abnormality affecting cognitive ability * Other malignancy except effectively treated squamous cell or basal cell skin cancer, * Other situations that the researchers think should be excluded
References
Publications (0)
Data not yet available
No reference posted for this study.