NCT00062335

Brief Summary

RATIONALE: Using computer systems that create a 3-dimensional picture of the tumor to plan treatment may enable doctors to provide more effective radiation therapy that will cause less damage to normal tissue. PURPOSE: This phase I trial is studying the side effects and best dose of high-dose 3-dimensional conformal radiation therapy in treating patients with inoperable stage I, stage II, or stage IIIA non-small cell lung cancer.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1 lung-cancer

Geographic Reach
3 countries

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2003

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

2.8 years

First QC Date

June 5, 2003

Last Update Submit

September 20, 2012

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancerstage II non-small cell lung cancerstage IIIA non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose as measured by NCI-CTC v2.0 during treatment and up to 6 months after completion of radiotherapy

Secondary Outcomes (2)

  • Late toxicity measured every 2 months in year 1, then every 3 months in year 2, and then every 6 months thereafter

  • Disease progression measured every 2 months in year 1, then every 3 months in year 2, and then every 6 months thereafter

Interventions

radiation therapyRADIATION

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer * Medically inoperable stage I or II disease * Stage III disease eligible provided the following are true: * No supraclavicular node involvement * No peripherally located lower lobe tumor AND contralateral upper mediastinal node involvement * No distant metastasis * No malignant pleural or pericardial effusion PATIENT CHARACTERISTICS: Age * Not specified Performance status * WHO 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Cardiovascular * No prior myocardial infarction * No prior complete bundle branch block * No other prior cardiovascular disease resulting in New York Heart Association class III or IV heart disease * No clinically significant cardiac arrhythmias * No congestive heart failure Pulmonary * FEV\_1 at least 1.2 L OR * DLCO at least 60% Other * No other prior or concurrent malignancy except cured basal cell skin cancer or carcinoma in situ of the cervix * No intractable or uncontrolled infection * No psychological, familial, social, or geographical condition that would preclude study compliance and follow-up * Able to tolerate a course of radiotherapy PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * At least 3 weeks since prior chemotherapy * No prior anthracyclines * No concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy to the chest area Surgery * No prior therapeutic surgery to the chest area Other * No other prior therapy to the chest area

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (7)

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Academisch Ziekenhuis der Vrije Universiteit Brussel

Brussels, 1090, Belgium

Location

Akademisch Ziekenhuis Gent

Ghent, B-9000, Belgium

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Institut Curie - Section Medicale

Paris, 75248, France

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Jacques Bernier, MD, PhD

    Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2003

First Posted

June 6, 2003

Study Start

April 1, 2003

Primary Completion

February 1, 2006

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

FR(3)BE(3)CH(1)