NCT00986297

Brief Summary

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This phase I trial is studying the side effects and best dose of specialized radiation therapy in treating patients with stage II, stage III, stage IV, or recurrent non-small cell lung cancer and poor performance status.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1 lung-cancer

Geographic Reach
1 country

2 active sites

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

September 26, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2009

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Last Updated

August 20, 2020

Status Verified

May 1, 2014

Enrollment Period

3 years

First QC Date

September 26, 2009

Last Update Submit

August 19, 2020

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancerstage II non-small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung canceradenocarcinoma of the lungadenosquamous cell lung cancerbronchoalveolar cell lung cancerlarge cell lung cancersquamous cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Dose-limiting toxicity

    90 days

Secondary Outcomes (2)

  • Local regional tumor control

    6 month

  • Overall survival

    2 year

Study Arms (1)

arm one

OTHER

IGRT

Radiation: hypofractionated radiation therapy

Interventions

hypofractionated radiation therapyRADIATION

hypofractionated radiation therapy

Also known as: IGRT
arm one

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer * Stage II-IV and/or recurrent disease * No small cell histology * Measurable or evaluable disease * Tumor not amenable to surgical resection * Tumor not eligible for stereotactic body radiation therapy * No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields PATIENT CHARACTERISTICS: * Zubrod performance status 2-4 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must agree to use effective contraception * Must complete all required pretreatment evaluations PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 1 week since prior chemotherapy or chemoradiation therapy * No concurrent chemotherapy * No other concurrent antineoplastic therapy (including standard-fractionated radiotherapy to the chest, chemotherapy, biological therapy, vaccine therapy, and surgery) 1 week before, during, and for 1 week after completion of study therapy

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

Sponsors & Collaborators

Study Sites (2)

Stanford University

Stanford, California, 94305, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungAdenocarcinoma of LungAdenocarcinoma, Bronchiolo-Alveolar

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Robert D. Timmerman, MD

    Simmons Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2009

First Posted

September 29, 2009

Study Start

October 1, 2009

Primary Completion

October 1, 2012

Last Updated

August 20, 2020

Record last verified: 2014-05

Locations

US(2)