Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal Cancer

NCT01291823 | Unknown Phase 2 DMC

• 1 other identifier: ZhejiangCH10
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Esophageal Cancer

Keywords

gefitinib; radiation; esophageal cancer

Outcome Measures

Primary Outcomes (1)

• Tumor response rate

  1 month after the thoracic radiotherapy and concurrent gefitinib treatment

Secondary Outcomes (1)

• The safety (The safety was evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0.)

  1 month after treatment

Study Arms (1)

Concomitant Gefitinib and radiotherapy

EXPERIMENTAL

Patients received Gefitinib and radiation therapy

Drug: gefitinib; Radiation: Thoracic radiotherapy

Interventions

gefitinib DRUG

gefitinib 250mg/day

Concomitant Gefitinib and radiotherapy

Thoracic radiotherapy RADIATION

Thoracic radiotherapy 54-60Gy over 30 fraction

Concomitant Gefitinib and radiotherapy

Eligibility Criteria

• Age: 70 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mao Weimin, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Xu yaping, MD

  0086-571-88122082

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mao Weimin, MD

CONTACT

0086-571-88122222; maowmzj1218@163.com

Xu Yaping, MD

CONTACT

0086-571-88122082; xuyaping1207@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 4, 2011
• First Posted: February 8, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2014
• Last Updated: February 8, 2011

Record last verified: 2011-02

Locations

CN (1)