Clinical trial · Interventional
Neoadjuvant Triplet Chemotherapy Regimen in Patients With Locally Advanced Rectal Cancer
A Pilot Phase II Study of Neoadjuvant Triplet Chemotherapy Regimen (FOLFOXIRI) in Patients With Locally Advanced Rectal Cancer
NCT03443661CI-TRIAL-00049763completedPhase 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)
This study aims to investigate the feasibility, safety and efficacy of triplet regimen of neoadjuvant chemotherapy in 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 |
|---|---|---|---|
| Locally Advanced Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFOXIRI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FOLFOXIRI
- description
- oxaliplatin 85 mg/m2 irinotecan 150 mg/m2, 5FU 2,400 mg/m2 by 46 h infusion repeated at 2week intervals
- interventionNames
- Drug: FOLFOXIRI
Primary outcomes (1)
- measure
- pCR
- timeFrame
- 1 year
- description
- Pathological complete response according to Mandard tumor regression grading
Secondary outcomes (3)
- measure
- R0 resection rate
- timeFrame
- 1 year
- description
- R0 resection rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed locally advanced rectal cancer; 2. 18-70 years ; 3. Clinicalstage:T3,4a,N0,M0;T1-4a,N+,M0; 4. Tumor from anus \>5cm and ≤15cm; 5. ECOG=0-1; 6. Available organ function:ALT≤1.5xULN;AST≤1.5xULN;TBIL≤1.0xULN; NEUT≥2×109/L;PLT≥100×109/L;Hb≥90g/L;Creatinine≤1.0xULN; 7. Informed consent; 8. UGT1A1:UGT1A1\*1/UGT1A1\*1,UGT1A1\*1/UGT1A1\*28,UGT1A1\*1/UGT1A1\*6; Exclusion Criteria: 1. Clinical stage T4b or unresectable disease; 2. History of pelvic radiotherapy; 3. History of chemotherapy within 5 years; 4. History of chronic diarrhea; 5. Tumor causes intestinal obstruction, intestinal perforation, and severe bleeding; 6. Hepatitis B surface antigen positive; Hepatitis C virus infection; Cirrhosis of the liver for any cause; 7. UGT1A1:UGT1A1\*28/UGT1A1\*28,UGT1A1\*6/UGT1A1\*6; 8. Other cancers in the past 5 years, except for cervical carcinoma in situ or non-melanoma skin cancer; 9. Myocardial infarction (in the last 6 months), severe instability angina, congestive heart failure; interstitial pneumonia,pulmonary fibrosis, uncontrolled diabetes, renal insufficiency; 10. Mental illness;Pregnant or lactating women;
References
Publications (1)
- DERIVEDZhang W, Zhou H, Jiang J, Zhu Y, Zou S, Jiang L, Tang Y, Liang J, Sun Y, Jiang Z, Qu W, Li Y, Zhou A. Neoadjuvant chemotherapy with modified FOLFOXIRI for locally advanced rectal cancer to transform effectively EMVI and MRF from positive to negative: results of a long-term single center phase 2 clinical trial. BMC Cancer. 2023 Jun 27;23(1):592. doi: 10.1186/s12885-023-11103-x. PMID 37370032