Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal Cancer

• Sponsor: Zhejiang Cancer Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01291823
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arm: 1
• Duration (Months): 48
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

Elderly patients with esophageal cancer will receive thoracic radiation therapy 54-60Gy over 30 fractions, and concurrent with Gefitinib.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer	Drug: gefitinib; Radiation: Thoracic radiotherapy	Phase 2

Detailed Description

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal
• Study Start Date: Dec 1, 2010
• Anticipated Primary Completion Date: Dec 1, 2012
• Anticipated Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Concomitant Gefitinib and radiotherapy Patients received Gefitinib and radiation therapy	Drug: gefitinib; gefitinib 250mg/day; Radiation: Thoracic radiotherapy; Thoracic radiotherapy 54-60Gy over 30 fraction

Outcome Measures

Primary Outcome Measures

1. Tumor response rate [1 month after the thoracic radiotherapy and concurrent gefitinib treatment]

Secondary Outcome Measures

1. The safety (The safety was evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0.) [1 month after treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhejiang Cancer Hospital	Hangzhou	Zhejiang	China	310022

Sponsors and Collaborators

• Zhejiang Cancer Hospital

Investigators

• Principal Investigator: Mao Weimin, MD, Zhejiang Cancer Hospital
• Principal Investigator: Xu yaping, MD, 0086-571-88122082

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01291823
• Other Study ID Numbers: ZhejiangCH10
• First Posted: Feb 8, 2011
• Last Update Posted: Feb 8, 2011
• Last Verified: Feb 1, 2011

• Keywords provided by , ,: gefitinib; radiation; esophageal cancer
• Additional relevant MeSH terms: Esophageal Neoplasms; Gefitinib

Study Results

No Results Posted as of Feb 8, 2011