Clinical trial · Interventional
Cetuximab and Radiation Therapy for Surgically Resectable Esophageal and Gastroesophageal (GE) Junction Carcinomas
A Pilot Study With Cetuximab and Radiation Therapy for Patients With Surgically Resectable Esophageal and GE Junction Carcinomas: Hoosier Oncology Group Study (GI05-92)
NCT00319735CI-TRIAL-00021954completedPhase 2Results postedClinicalTrials.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)
The interaction of epidermal growth factor receptor (EGFR) inhibitory agents such as cetuximab combined with radiation shows promising results. EGFR inhibitory agents also enhance radiation-induced apoptosis and inhibit radiation induced damage repair. These interactions may represent the principle effects that contribute to the synergy between EGFR and radiation. This trial will investigate the feasibility and activity of this combination in patients with surgically resectable disease.
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 |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation Therapy | Procedure | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
| Tissue Sample | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Investigational Treatment
- description
- * Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) * Cetuximab 250 mg/m2 IV over 60 minutes Day -7 * Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36 * Combined with radiation therapy for six weeks. * Surgery for esophageal resection after 6 to 8 week rest period. Subjects who consent will provide tissue samples.
- interventionNames
- Procedure: Radiation Therapy
- Procedure: Surgery
- Procedure: Tissue Sample
Primary outcomes (1)
- measure
- Complete Pathologic Response (pCR)
- timeFrame
- 36 months
- description
- To evaluate complete pathologic response rate in patients with esophageal and GE junction carcinomas. Complete pathologic response (pCR) is defined as the absence of tumor cells on the resected specimen in the esophagus and/or GE junction.
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathological diagnosis of either squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction. * Clinical stage IIA, IIB or III without metastatic disease * Patients must have documented EGFR status or have tumor tissue available for assessment of EGFR status by IHC * Patients must be surgical candidates as determined by surgical consult. * Patients must agree to surgery. * ECOG performance status 0 or 2 * Absolute neutrophil count (ANC) \> 1,000 mm3 * Platelet count \> 75,000 mm3· Hemoglobin \> 10g/dL * Bilirubin \< 2.5 X upper limit of normal * AST (SGOT) or ALT (SGPT) \< 5.0 ´ upper limit of normal * Creatinine \< 2.0 X upper limit of normal Exclusion Criteria: * No history of or current brain metastasis. * No significant history of uncontrolled cardiac disease; i.e. uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction. * No history of interstitial pneumonitis or pulmonary fibrosis, or suspicion of interstitial pneumonitis or pulmonary fibrosis on imaging. * No concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s). * No prior use of radiation or chemotherapy for cancer of the esophagus or GE junction * No prior therapy that specifically and directly targets the EGFR pathway (such as kinase inhibitors and antibodies directed against the HER family receptors). * No prior severe infusion reaction to a monoclonal antibody. * No major surgery within 28 days prior to being registered for protocol therapy. * No clinically significant infections as judged by the treating investigator. * No acute hepatitis or known HIV. * No other active malignancies. * Negative pregnancy test. * No female patients currently breastfeeding.
References
Publications (1)
- RESULTBecerra CR, Hanna N, McCollum AD, Becharm N, Timmerman RD, DiMaio M, Kesler KA, Yu M, Yan T, Choy H. A phase II study with cetuximab and radiation therapy for patients with surgically resectable esophageal and GE junction carcinomas: Hoosier Oncology Group G05-92. J Thorac Oncol. 2013 Nov;8(11):1425-9. doi: 10.1097/JTO.0b013e3182a46c3b. PMID 24084441