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A Phase II Study of Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal


Phase 2
70 Years
85 Years
Open (Enrolling)
Both
Esophageal Cancer

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Trial Information

A Phase II Study of Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal


Purpose: to evaluate the efficacy and toxicity of a concomitant treatment using EGFR-TKI and
thoracic radiation in elderly patients with esophageal Cancer.

Methods:Patients(>70 years old) with esophageal Cancer will receive thoracic radiation
therapy 54-60 Gy over 30 fractions and concurrent with gefitinib 250mg/day.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response rate

Outcome Time Frame:

1 month after the thoracic radiotherapy and concurrent gefitinib treatment

Safety Issue:

Yes

Principal Investigator

Mao Weimin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Zhejiang Cancer Hospital

Authority:

China: Food and Drug Administration

Study ID:

ZhejiangCH10

NCT ID:

NCT01291823

Start Date:

December 2010

Completion Date:

December 2014

Related Keywords:

  • Esophageal Cancer
  • gefitinib
  • radiation
  • esophageal cancer
  • Esophageal Diseases
  • Esophageal Neoplasms

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