Clinical trial · Interventional
Preoperative Chemoradiotherapy With Cetuximab in Rectal Cancer
A Phase II Study of Pre-Operative Concurrent Chemoradiotherapy With Cetuximab, Irinotecan, and Capecitabine in Resectable Rectal Cancer
NCT00506844CI-TRIAL-00000806ERBIRIXunknownPhase 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 estimate the pathologic complete response rate of cetuximab, irinotecan, and capecitabine concurrent with radiotherapy given preoperatively in patients with 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 Treatment | — | UNRESOLVED | — |
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab, Irinotecan, Capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Pathologic stage Tumor regression grade
- timeFrame
- After operation
Secondary outcomes (2)
- measure
- Toxicity measured by NCICTC v3
- timeFrame
- During chemoradiation
- measure
- Disease-free survival
- timeFrame
- Three year
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 * Stage T3/T4 ± N+ by MRI ± endorectal ultrasonography * ECOG performance status 0-2 * No prior chemotherapy, radiotherapy to pelvis, immunotherapy, and EGFR pathway targeting therapy * Adequate organ functions * Patients must sign the informed consent Exclusion Criteria: * Malignant disease of the rectum other than adenocarcinoma or arisen from chronic inflammatory bowel disease * Any defined hereditary colorectal cancer * Any unresected synchronous colon cancer * R0 resection of tumor is not clinically possible * 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 with 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 * History of severe pulmonary disease * Pregnant or lactating women or patients of childbearing potential not predicting adequate contraception
References
Publications (0)
Data not yet available
No reference posted for this study.