NCT00005666

Brief Summary

This is a research study for patients with inoperable lung cancer called non-small cell lung cancer (NSCLC). Currently, the information from a radiological test, computed tomography (CT) scan of the chest, is used to design the best arrangement of radiation beams which will kill tumor cells and still spare the normal parts of lungs and other normal organs in the chest. The purpose of this study is to explore whether adding information from another radiological test, called positron emission tomography (PET), will improve the accuracy of the radiation beam arrangement designed to treat lung cancer. A PET scan is a way to picture the biochemistry of tissues and organs: of how tissues in the body take up glucose, a normal nutrient of the body. The researchers will attempt to create radiation treatment plans from PET images alone and compare differences between hypothetical plans and standard-of-care CT-based radiation treatment plans. Because there is honest uncertainty about the contribution of PET to radiation treatment planning, it is possible that there will be no difference between a CT-based treatment plan and one resulting from PET information. It is also possible that the addition of PET may result in a radiation beam arrangement that may better control lung cancer. The addition of PET may also result in treating less normal tissues, which may lower the risk of radiation side effects. This study will provide the preliminary data necessary to design a larger clinical trial that may define the role of PET in radiation treatment planning.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2000

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2000

Completed
Last Updated

June 24, 2005

Status Verified

November 1, 2001

First QC Date

May 19, 2000

Last Update Submit

June 23, 2005

Conditions

Keywords

Diagnostic imaging

Interventions

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed locally advanced NSCLC (squamous, large cell undifferentiated or adenocarcinoma).
  • Disease limited to the thorax, adjacent mediastinum and neurovascular structures, and supraclavicular or scalene lymph node area, as defined by the AJCC Staging System. This includes patients with Stage IIIA and IIIB disease.
  • Performance status of 0-2 by Southwest Oncology Group criteria.
  • Medically inoperable patients (Stage I or II)
  • Locoregional recurrent tumor following surgery will be eligible provided they meet other eligibility criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH B2 C490 Box 0010 E. Medical Center Drive

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

May 19, 2000

First Posted

May 22, 2000

Last Updated

June 24, 2005

Record last verified: 2001-11

Locations