Clinical trial · Interventional
Genotype-driven Phase I Study of Irinotecan Administered in Neoadjuvant Chemoradiotherapy in Patients With Stage II/III Rectal Cancer
NCT01474187CI-TRIAL-00005786unknownPhase 1ClinicalTrials.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)
Irinotecan is one of effective drugs for colorectal cancer. In neoadjuvant chemoradiotherapy (CRT), Irinotecan is prescribed in a low dose of 50mg/m2/week because of toxicity. Some current studies showed that irinotecan's dose can be increased significantly for those patients with 6/6 or 6/7 genotype of UGT1A1. therefore, the investigators designed this trial to explore the maximal tolerable dose (MTD) of Irinotecan in combined neoadjuvant CRT.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Irinotecan
- description
- irinotecan dose initial from 50mg/m2/week, increased by 15mg/mg/week
- interventionNames
- Drug: Irinotecan
- Drug: Capecitabine
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- toxicity
- timeFrame
- 5 weeks
- description
- * Grade 4 hemato-toxicity * Grade 3 nonhemato-toxicity (not include grade 3 anal verge skin toxicity)
Secondary outcomes (1)
- measure
- pathological complete response (pCR)
- timeFrame
- within 14days after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with rectal adenocarcinoma * Clinical staged T3/4 or any node-positive disease * Age of 18-75 years * Karnofsky Performance Status \> 80 * Adequate bone marrow reserve, renal and hepatic functions * Without previous antitumoural chemotherapy * No evidence of metastatic disease * Written informed consent before randomization * UGT1A1's genotype of 6/6 or 6/7 Exclusion Criteria: * Clinical staged I or IV * Age of \<18 or \>75 years * Karnofsky Performance Status \< 80 * Previous pelvis radiotherapy * Previous antitumoural chemotherapy * Clinically significant internal disease * Refuse to write informed consent before randomization * UGT1A1's genotype of 7/7
References
Publications (0)
Data not yet available
No reference posted for this study.