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Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC) (RT0901)

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Erlotinib
Thoracic radiotherapy
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Non-small cell lung cancer, EGFR-TKI, Erlotinib, Radiotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Concomitant Erlotinib and radiotherapy

Arm Description

Patients received Erlotinib and radiation therapy.

Outcomes

Primary Outcome Measures

Tumor response rate (Response was analyzed according to the RECIST system, based on CT scans.)
The safety (The safety was evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0.)

Secondary Outcome Measures

Progression free survival
The overall survival
Quality of Life (QoL was evaluated according to the FACT-L.)

Full Information

First Posted
January 14, 2010
Last Updated
May 13, 2010
Sponsor
Zhejiang Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01091376
Brief Title
Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC)
Acronym
RT0901
Official Title
A Phase II Study of Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
March 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Zhejiang Cancer Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Non-small cell lung cancer, EGFR-TKI, Erlotinib, Radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Concomitant Erlotinib and radiotherapy
Arm Type
Experimental
Arm Description
Patients received Erlotinib and radiation therapy.
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Intervention Description
Erlotinib 150mg/day
Intervention Type
Radiation
Intervention Name(s)
Thoracic radiotherapy
Intervention Description
60-70Gy/30-35f
Primary Outcome Measure Information:
Title
Tumor response rate (Response was analyzed according to the RECIST system, based on CT scans.)
Time Frame
After the thoracic radiotherapy and concurrent Erlotinib treatment
Title
The safety (The safety was evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0.)
Time Frame
Every one month
Secondary Outcome Measure Information:
Title
Progression free survival
Time Frame
The time from the start of treatment to diease progression
Title
The overall survival
Time Frame
The time from the start of treatment to death
Title
Quality of Life (QoL was evaluated according to the FACT-L.)
Time Frame
Every one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shenglin Ma, MD
Phone
+8657188122568
Email
mashenglin@medmail.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yaping Xu, MD
Phone
+8657188122082
Email
xuyaping1207@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shenglin Ma, MD
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lvhua Wang, MD
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shenglin Ma, MD
Phone
+8657188122568
Email
mashenglin@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Yaping Xu, MD
Phone
+8657188122082
Email
xuyaping1207@gmail.com
First Name & Middle Initial & Last Name & Degree
Shenglin Ma, MD
First Name & Middle Initial & Last Name & Degree
Yaping Xu, MD

12. IPD Sharing Statement

Learn more about this trial

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

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