Clinical trial · Interventional
Neoadjuvant FOLFOXIRI Chemotherapy Alone for Locally Advanced Rectal Cancer
A Phase II Study of Neoadjuvant FOLFOXIRI Chemotherapy Alone in Treating Patients With Locally Advanced Rectal Cancer
NCT02217020CI-TRIAL-00051264FORTUNEcompletedPhase 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)
The standard treatment for stage 2/3 rectal cancer is neoadjuvant 5-Fu based chemoradiation. However, preoperative radiation cause kinds of adverse events, some were irreversible. And the survival benefit was not obvious. Whether chemotherapy alone is effective enough in treating rectal cancer is not yet known. Here, the investigators chose all the three active cytotoxic agents (5-FU, Oxaliplatin, Irinotecan) as the neoadjuvant treatment regimen (FOLFOXIRI). The purpose of the study is to evaluate the efficacy of FOLFOXIRI as neoadjuvant regimen in treating patients with locally advanced rectal cancer.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFOXIRI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FOLFOXIRI
- description
- patients received FOLFOXIRI alone for 4 cycles before surgery.
- interventionNames
- Drug: FOLFOXIRI
Primary outcomes (1)
- measure
- The ratio of tumor downstaging to stage 0 and stage I
- timeFrame
- 2 year
- description
- Tumor downstaging from stage II or III to pathologic complete response (stage 0) and stage I
Secondary outcomes (4)
- measure
- Average neoadjuvant rectal cancer score
- timeFrame
- 2 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria * Diagnosis of adenocarcinoma of the rectum * Age: 18-70 years old * Signed informed consent; able to comply with study and/or follow- up procedures * Stage of the primary tumor may be determined by ultrasound or MRI * Stage II (T3-4, N0 \[N0 is defined as all imaged lymph nodes \< 1.0 cm\]) OR stage III (T1-4, N1-2 \[with the definition of a clinically positive lymph node being any node ≥ 1.0 cm\] * Tumor palpable by digital rectal exam OR accessible by proctoscope or sigmoidoscope * Distal border of the tumor must be located \< 12 cm from the anal verge * Tumor amenable to curative resection * Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: * Leukocytes ≥ 3.0 x109/ L, absolute neutrophil count (ANC) ≥ 1.5 x109/ L, platelet count ≥ 100 x109/ L, hemoglobin (Hb) ≥ 9g/ dL. * Total bilirubin ≤1.5 x the upper limit of normal (ULN). * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN. * Alkaline phosphatase limit ≤ 5x ULN. * Amylase and lipase ≤ 1.5 x the ULN. * Serum creatinine ≤ 1.5 x the ULN. * Calculated creatinine clearance or 24 hour creatinine clearance ≥ 50 mL/ min. * No renal disease that would preclude study treatment or follow-up * ECOG status: 0～1 Exclusion Criteria: * Hypersensitivity to fluorouracil, oxaliplatin or irinotecan. * No More than 4 weeks since prior participation in any investigational drug study * More than 4 weeks since prior participation in any investigational drug study * Clear indication of involvement of the pelvic side walls by imaging * With distant metastasis * History of invasive rectal malignancy, regardless of disease-free interval * Fertile patients must use effective contraception * Uncontrolled hypertension * Cardiovascular disease that would preclude study treatment or follow-up * Lack of upper gastrointestinal tract integrity or malabsorption syndrome，active upper gastrointestinal tract bleeding * Synchronous colon cancer * Pregnant or nursing, Fertile patients do not use effective contraception * Other malignancy within the past 5 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum * No psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation * patients refused to signed informed consent.
References
Publications (1)
- DERIVEDZhang J, Li J, Huang M, Xie X, Cai Y, Hu H, Ling J, Wu Z, Deng Y. Neoadjuvant Modified FOLFOXIRI With Selective Radiotherapy in Locally Advanced Rectal Cancer: Long-term Outcomes of Phase II Study and Propensity-Score-Matched Comparison With Chemoradiotherapy. Dis Colon Rectum. 2023 Jul 1;66(7):934-945. doi: 10.1097/DCR.0000000000002424. Epub 2022 Jul 12. PMID 35834598