Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC)

NCT01091376 | Unknown Phase 2 DMC

• 1 other identifier: ZhejiangCH02
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Concomitant chemoradiotherapy is the standard treatment of locally advanced,non-resectable, non-small cell lung cancer (NSCLC). However,the optimal chemotherapy regimen is still controversial.The objective of this study was to evaluate the efficacy and toxicity of a concomitant treatment using Erlotinib and radiotherapy followed by Erlotinib consolidation treatment.

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small cell lung cancer; EGFR-TKI; Erlotinib; Radiotherapy

Outcome Measures

Primary Outcomes (2)

• Tumor response rate (Response was analyzed according to the RECIST system, based on CT scans.)

  After the thoracic radiotherapy and concurrent Erlotinib treatment

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

  Every one month

Secondary Outcomes (3)

• Progression free survival

  The time from the start of treatment to diease progression

• The overall survival

  The time from the start of treatment to death

• Quality of Life (QoL was evaluated according to the FACT-L.)

  Every one month

Study Arms (1)

Concomitant Erlotinib and radiotherapy

EXPERIMENTAL

Patients received Erlotinib and radiation therapy.

Drug: Erlotinib; Radiation: Thoracic radiotherapy

Interventions

Erlotinib DRUG

Erlotinib 150mg/day

Concomitant Erlotinib and radiotherapy

Thoracic radiotherapy RADIATION

60-70Gy/30-35f

Concomitant Erlotinib and radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven non-small cell lung cancer (squamous cell carcinoma, adenocarcinoma, large cell carcinoma and etc)
• Tumor EGFR mutation
• Presence of measurable disease by RECIST
• stage IIIA or IIIB, non-resectable
• ECOG performance status 0-2
• No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy
• Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital.

You may not qualify if:

• Carcinoid tumor, small cell carcinoma of lung
• Patients with any distant metastasis
• History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
• Any other morbidity or situation with contraindication for radiotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)
• Pregnant or lactating women, women who has not taken test of pregnancy (within 7 days before the first administration) and pregnant women
• Women and men of childbearing potential who have no willing of employing adequate contraception
• Tumor EGFR wild

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Shenglin Ma, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Lvhua Wang, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shenglin Ma, MD

CONTACT

+8657188122568; mashenglin@medmail.com.cn

Yaping Xu, MD

CONTACT

+8657188122082; xuyaping1207@gmail.com

Study Design

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

Study Record Dates

• First Submitted: January 14, 2010
• First Posted: March 24, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2013
• Last Updated: May 17, 2010

Record last verified: 2010-03

Locations

CN (1)