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

NCT ID: NCT01091376

Last Updated: 2010-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Patients with non-resectable Non-small Cell Lung Cancer will receive thoracic radiation therapy 60-70 Gy over 30-35 fractions and concurrent with Erlotinib 150mg/day. Followed by Erlotinib 150 mg/day consolidation treatment.

Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Concomitant Erlotinib and radiotherapy

Patients received Erlotinib and radiation therapy.

Group Type EXPERIMENTAL

Erlotinib

Intervention Type DRUG

Erlotinib 150mg/day

Thoracic radiotherapy

Intervention Type RADIATION

60-70Gy/30-35f

Interventions

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Erlotinib

Erlotinib 150mg/day

Intervention Type DRUG

Thoracic radiotherapy

60-70Gy/30-35f

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhejiang Cancer Hospital; Chinese Academy of Medical Sciences Cancer Hospital

Principal Investigators

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Shenglin Ma, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Lvhua Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

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Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shenglin Ma, MD

Role: CONTACT

+8657188122568

Yaping Xu, MD

Role: CONTACT

+8657188122082

Facility Contacts

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Shenglin Ma, MD

Role: primary

+8657188122568

Yaping Xu, MD

Role: backup

+8657188122082

Other Identifiers

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ZhejiangCH02

Identifier Type: -

Identifier Source: org_study_id

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