Clinical trial · Interventional
Preoperative Chemoradiation With Capecitabine and Cetuximab
Preoperative Chemoradiation With Capecitabine and Cetuximab Within a Multidisciplinary Therapeutic Approach in Patients With Operable T3-T4 Rectal Cancer: a Phase II Study
NCT00297128CI-TRIAL-00005992completedPhase 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)
* feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma * collection of response rate (T-downstaging, pathological complete remission), correlation of responsiveness with EGFR-status
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Cetuximab | Drug | Cetuximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- ACTIVE_COMPARATOR
- label
- 1
- interventionNames
- Drug: Capecitabine
- Drug: Cetuximab
Primary outcomes (1)
- measure
- feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma
- timeFrame
- descriptive evaluation
Secondary outcomes (1)
- measure
- collection of response rate (T-downstaging, pCR), correlation of responsiveness with EGFR-status
- timeFrame
- description evaluation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 18-80 * bioptical confirmed adenocarcinoma of the rectum in operable T3-T4NxM0 status. In spite of infiltration of the neighbouring organs the tumor has to be basically surgically complete resectable * no former chemotherapy, radiotherapy of pelvis or abdomen and/or tumor resection of a rectum carcinoma * WHO performance status 0-2 * adequate bone marrow reserve (granulocytes - not more than 1.500/µl; thrombocytes - not more than 100.000/µl) * adequate hepatic function ( bilirubin - not more than 1.5 x ULN; GOT and GPT - not more than 3.5 x ULN) * adequate renal function (creatinin - not more than 1.5 mg/dl) * women of childbearing potential: exclusion of pregnancy (negative urin or serum pregnancy test) * willingness of women of childbearing potential and accordingly of potent men to use approved contraceptives (e.g. birth-control pill, loop, condom) during and at least 3 month after conclusion of the study * life expectancy of at least 3 month * signed Informed Consent before recruitment * exclusion of distant metastases at the time of recruitment Exclusion Criteria: * former radiotherapy of pelvis or abdomen * former chemotherapy * any other kind of malign tumor (except adequate treated skin basalioma or in situ cervical carcinoma) in the last 5 years * general contraindication or known hypersensitivity against Cetuximab and/or Capecitabine * Non malign disease, if there is a contraindication with radiotherapy or chemotherapy with Cetuximab and Capecitabine or a resection of the rectum: high-graded cardiac insufficiency, angina pectoris, hypertension or arrhythmia, hepatic disease, significant neurological or psychiatric disorders * florid, serious infections at the time of recruitment * legally limited contractual capability or evidence of neurological or psychiatric disease, if it will constrict the patients compliance in the opinion of the investigator * evidence of lacking cooperation of the patient * pregnant or breast feeding women
References
Publications (0)
Data not yet available
No reference posted for this study.