Clinical trial · Interventional
Study of Combination of Cetuximab and Radiotherapy Added to the Standard Treatment for Oesophageal Adenocarcinoma
Multi-Modality Treatment of Resectable Oesophageal Adenocarcinoma Using Peri-operative Chemotherapy With Additional Pre-operative Combined Radiotherapy and Cetuximab
NCT00827671CI-TRIAL-00031991TRACCterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Experimental treatment not feasible due to high rate of drop out
Summary
Brief summary (as posted)
The purpose of this study is to determine whether the addition of the combination between cetuximab and radiotherapy to the standard chemotherapy for resectable oesophageal cancer is safe and adds efficacy.
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 |
|---|---|---|---|
| Resectable Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cetuximab | Drug | Cetuximab | ALIAS |
| radiotherapy to oesophageal tumour | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Pre-operative chemotherapy
- interventionNames
- Drug: cetuximab
- Radiation: radiotherapy to oesophageal tumour
Primary outcomes (2)
- measure
- pathological complete remission
- timeFrame
- 1 month
- description
- determination of tumor residual cell content in surgical specimen
- measure
- Resectability rate defined as the number of patients abke to undergo resection after neo-adjuvant treatment
- timeFrame
- 6 months
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven resectable adenocarcinoma of the lower oesophagus and gastric-oesophageal junction * Tumour stage: T2-3 N0-1 M0, as assessed by endoscopic ultrasound and CT-scan of thorax and abdomen and ultrasound neck region. For the patients treated in this study the gastro-oesophageal junctional tumors will be staged as oesophageal tumors with respect to their lymphnode metastases. * Age \>18y and written informed consent after at least 4 days of deliberation time from the moment the patient information has been given and has been explained. * Weight loss \< 10% in 0.5 yr * WHO performance status 0-1 * No prior radiotherapy or chemotherapy for the adenocarcinoma of the oesophagus Exclusion Criteria: * Previous malignancy other than basal cell carcinoma of the skin or local resection for cervical carcinoma in situ. * Inadequate organ function as defined by: * Inadequate haematology (Hb \< 5,5 mmol/L (red blood cell transfusions are allowed to increase the Hb at the discretion of the investigator) - neutrophils \< 1,5 109/L -platelets \<100\*109/L), * Liver enzyme elevation (bili \> 1,5\*ULN - ASAT \> 2,5\*ULN - ALAT \> 2,5\*ULN) or * Impaired renal function (creatinine clearance by cockcroft \< 60 cc/min) * Proteinuria \>1,0gr/24hr * Tumour stage: M1a and/or tumour length \> 8 cm and/or \> 5 cm radially * Major surgery within 4 weeks prior to the start of study treatment * Bleeding disorder * Known allergy to one of the study drugs used * Use of any substance known to interfere with the chemotherapy clearance * Previous radiotherapy to the chest * Significant concomitant diseases preventing the safe administration of study drugs or likely to interfere with study assessments * Uncontrolled angina pectoris; cardiac failure or clinically significant arrhythmias * Continuous use of immunosuppressive agents * Concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine * Prior exposure to anti-EGFR targeting agents. * Hearing loss \> 25 dB under normal * Neurotoxicity \> CTC grade 1 * Pregnancy or breast feeding * Patients (M/F) with reproductive potential not implementing adequate contraceptive measures
References
Publications (1)
- DERIVEDUbink I, van der Sluis P, Schipper M, Reerink O, Voest E, Borel-Rinkes I, Wijrdeman H, Vleggaar F, Agterof M, Overkleeft E, Siersema P, van Hillegersberg R, Lolkema MP. Adding preoperative radiotherapy plus cetuximab to perioperative chemotherapy for resectable esophageal adenocarcinoma: a single-center prospective phase II trial. Oncologist. 2014 Jan;19(1):32-3. doi: 10.1634/theoncologist.2013-0254. Epub 2013 Dec 12. PMID 24335595