Clinical trial · Interventional
Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal Cancer
A Phase II Study of Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal
NCT01291823CI-TRIAL-00004394unknownPhase 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)
Elderly patients with esophageal cancer will receive thoracic radiation therapy 54-60Gy over 30 fractions, and concurrent with Gefitinib.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gefitinib | Drug | Gefitinib | ALIAS |
| Thoracic radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Concomitant Gefitinib and radiotherapy
- description
- Patients received Gefitinib and radiation therapy
- interventionNames
- Drug: gefitinib
- Radiation: Thoracic radiotherapy
Primary outcomes (1)
- measure
- Tumor response rate
- timeFrame
- 1 month after the thoracic radiotherapy and concurrent gefitinib treatment
Secondary outcomes (1)
- measure
- The safety (The safety was evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0.)
- timeFrame
- 1 month after treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically documented diagnosis of esophageal Cancer * Disease must be encompassed in a radiotherapy field.Patients with celiac, perigastric, mediastinal or supraclavicular adenopathy are eligible * age:70-85 years * Written informed consent. * Performance status of 0 to 2 * Neutrophil count \>1.5 x 10 to the 9th power/L and platelets \> 100 x 10 to the 9th power/L. * Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN) Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN (or less than or equal to 5 times ULN in case of known liver involvement * Renal: Serum Creatinine less than or equal to 1.5 times upper limit of normal (ULN) Exclusion Criteria: * Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi. * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible). * Prior systemic chemotherapy or radiation therapy for esophageal cancer
References
Publications (0)
Data not yet available
No reference posted for this study.