Clinical trial · Interventional
Erlotinib and Radiation Therapy in Treating Older Patients With Stage I, Stage II, Stage III, or Stage IV Esophageal Cancer
Phase II Study of Erlotinib (Tarceva®) and Radiotherapy for Elderly Patients With Esophageal Carcinoma
- 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)
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving erlotinib together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving erlotinib together with radiation therapy works in treating older patients with stage I, stage II, stage III, or stage IV esophageal cancer.
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 |
|---|---|---|---|
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oral Erlotinib
- description
- Patients receive oral erlotinib hydrochloride once daily for 1 year
- interventionNames
- Drug: erlotinib hydrochloride
- Other: immunohistochemistry staining method
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 5 years
Secondary outcomes (7)
- measure
- Complete Response
- timeFrame
- 4-8 weeks after completion of radiation.
- description
- Response assessment by CT scans and upper endoscopy performed between 4-8 weeks after completion of radiation. Complete Response (CR) is defined as absence of viable tumor in endoscopic evaluation post chemoradiation, with four-quadrant biopsies taken at 1 cm intervals throughout length of original tumor.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Biopsy-proven primary squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal (GE) junction
* GE junction tumors with 50% or more tumor located in the esophagus determined by radiologic or endoscopic evaluation
* Stage I-IVA disease determined by CT scan or MRI of the chest and abdomen
* Stage IVB disease allowed if metastases to distant regional lymph nodes (celiac or cervical) only and no other sites
* Not a surgical candidate and ineligible for chemotherapy due to any of the following:
* Neuropathy
* Cardiac disease
* Performance status 2
* General overall condition felt by the investigator to be a contraindication to platinum-based therapy
* Bronchoscopy with biopsy and cytology required if primary esophageal cancer is \< 26 cm from incisors
* No evidence of clinically active interstitial lung disease (patients who are asymptomatic with chronic, stable, radiographic lung changes allowed)
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy \> 4 months
* WBC ≥ 3,000/mm³
* ANC ≥ 1,500/mm³
* Platelet count \> 100,000/mm³
* Bilirubin ≤ 1.3 mg/dL
* ALT and AST ≤ 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 2.5 times ULN
* No prior malignancies except basal cell or squamous cell skin cancer, in situ cervical cancer, or superficial transitional cell bladder cancer, unless diagnosed and/or treated \> 2 years prior to current study and are without evidence of recurrence
* No history of allergy to erlotinib or any of its excipients
* No serious, uncontrolled, concurrent infection
* No clinically serious, uncontrolled medical conditions that the investigator feels might compromise study participation
* No lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
* No unwillingness to participate or inability to comply with the protocol for the duration of the study
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy or radiotherapy for this tumor
* No prior resection or attempted resection of esophageal cancer
* No prior anti-epidermal growth factor receptor therapy (unless given in an adjuvant setting and completed at least 12 months earlier)
* No participation in any investigational drug study within the past 4 weeks
* No HIV-positive patients receiving antiretroviral therapy
* No concurrent CYP3A4/5 inducers or inhibitorsReferences
Publications (0)
Data not yet available