Clinical trial · Interventional
Preoperative Chemoradiotherapy With Capecitabine Plus Irinotecan in Rectal Cancer
A Phase Ⅱ Study of Pre-Operative Concurrent Chemoradiotherapy With Capecitabine Plus Irinotecan in Resectable Rectal Cancer.
NCT00506623CI-TRIAL-00000810unknownPhase 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 is to evaluate the pathologic complete response rate to pre-operative concurrent chemoradiotherapy with capecitabine plus irinotecan in resectable rectal cancer
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoadjuvant Therapy | — | UNRESOLVED | — |
| Rectal Neoplasm | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine, Irinotecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Pathologic stage Tumor regression grade
- timeFrame
- After operation
Secondary outcomes (1)
- measure
- Toxicity
- timeFrame
- During chemoradiation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the rectum * Distal margin of tumor located from 0 to 8 cm from anal verge * Tumor must be clinically resectable by surgery and R0 resection must be most likely * ECOG performance status 0-2 * No prior chemotherapy, radiotherapy to pelvis, and immunotherapy * Adequate organ functions * Patients must sign an informed consent Exclusion Criteria: * Malignant disease of the rectum other than adenocarcinoma or arisen from chronic inflammatory bowel disease * Any unresected synchronous colon cancer * Any distant metastasis * Intestinal obstruction or impending obstruction, but decompressing colostomy is permitted * Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix * Any other morbidity or situation with contraindication for chemoradiotherapy * Patients have history of significant gastric or small bowel resection, or malabsorption syndrome, or other lack of integrity of the upper gastrointestinal tract that may compromise the absorption of capecitabine * Pregnant or lactating women or patients of childbearing potential not practicing adequate contraception
References
Publications (0)
Data not yet available
No reference posted for this study.