NCT00520702

Brief Summary

Primary Objective:

  • Developing Common Toxicity Criteria (CTC) 3.0 grade \> 3 treatment related pneumonitis (TRP) or
  • Developing local-regional recurrence among patients treated with 3D conformal radiation therapy (CRT) (Arm 1) or intensity modulated radiation therapy (IMRT) (Arm 2). Secondary Objectives:
  • To assess and compare the time to develop CTC 3.0 grade \> 3 radiation esophagitis in patients with non-small cell lung cancer (NSCLC) treated in arm 1 and arm 2.
  • To investigate the association of inflammatory cytokines with the time to the development of radiation pneumonitis and outcomes to concurrent chemoradiation between arm 1 and arm 2.
  • To investigate the association of relevant pharmacogenetics, biomarkers, and gene polymorphisms with the time to the development of radiation pneumonitis and treatment outcomes to concurrent chemoradiation between arm 1 and arm 2.
  • To evaluate image guided adaptive radiation therapy (IGART) using weekly computed tomography (CT) on rail or cone beam CT in the assessment of tumor response and impact on treatment planning and delivery.
  • To compare overall survival, progression-free survival, median survival time, in arm 1 and arm 2.
  • To evaluate the role of functional image of fluorodeoxyglucose-positron emission tomography (FDG-PET) in assessing and predicting the time to the development of TRP and tumor response.
  • To measure and compare symptom burden over time of the treatment using MD Anderson Symptom Inventory (MDASI)-Lung in the 2 arms.
  • To determine the impact of comorbid conditions on survival.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P75+ for phase_2 lung-cancer

Timeline
Completed

Started Aug 2007

Longer than P75 for phase_2 lung-cancer

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 21, 2007

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 22, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2007

Completed
11.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2018

Completed
Last Updated

October 5, 2018

Status Verified

October 1, 2018

Enrollment Period

11.1 years

First QC Date

August 22, 2007

Last Update Submit

October 4, 2018

Conditions

Lung Cancer

Keywords

Non-Small Cell Lung CancerLung Cancer3-Dimensional Conformal Radiation TherapyIntensity Modulated Radiation Therapy3D CRTIMRTNSCLCTRPTreatment related pneumonitis

Outcome Measures

Primary Outcomes (1)

  • Time to Treatment Failure

    Time to treatment failure defined as from the time of randomization to the development of treatment related pneumonitis (TRP) or local-regional recurrence, whichever occurs first.

    3 months after radiation therapy

Study Arms (2)

3D CRT

ACTIVE COMPARATOR

3-Dimensional Conformal Radiation Therapy (3D CRT)

Procedure: 3-Dimensional Conformal Radiation Therapy

IMRT

ACTIVE COMPARATOR

Intensity-Modulated Radiation Therapy (IMRT)

Procedure: Intensity Modulated Radiation Therapy

Interventions

Intensity Modulated Radiation TherapyPROCEDURE

66 Gy in 33 Daily Fractions at 2 Gy per fraction.

Also known as: IMRT
IMRT
3-Dimensional Conformal Radiation TherapyPROCEDURE

66 Gy in 33 Daily Fractions at 2 Gy per fraction.

Also known as: 3D CRT
3D CRT

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically proven diagnosis of unresected loco-regionally advanced non-small cell lung cancer without evidence of hematogenous metastases, Stages IIB-IIIB without contralateral hilar nodal disease.
  • Patient is suitable for concurrent chemoradiation therapy per treating physician's assessment (kps \>/= 70, weight loss \< 10% in three months prior to diagnosis).
  • Patients with Stage IV NSCLC with solitary metastasis (brain, one side of adrenal gland, or one site of bone), who have clinical indication of concurrent chemoradiation to the primary disease in the lung are eligible.
  • Patients who received induction chemotherapy and then referred for concurrent chemoradiation are eligible.
  • Patients who had local regional recurrence after surgical resection and who are suitable for definitive concurrent chemoradiation are eligible.
  • Measurable disease by chest x-ray and/or contrast-enhanced CT, and/or PET scan
  • FEV 1\> 1000 cc
  • Pre-chemoradiation FDG-PET within 10 weeks prior to randomization. This PET/CT is a standard procedure for staging. It is strongly encouraged to have this PET/CT performed at the same time for 4-D CT simulation using the 4-D PET/CT scanner at the department of radiation oncology.
  • Patient will undergo routine standard pretreatment evaluations as decided by treating physician, which usually include magnetic resonance imaging (MRI) or CT of the brain, contrast CT scan of the thorax and upper abdomen, pulmonary functional test, single-photon emission computerized tomography (SPECT), liver function tests (LFT), blood chemistry, renal functional test, complete blood count.
  • Age \> 18, \< 80 years
  • Patient must sign study specific informed consent prior to study entry.

You may not qualify if:

  • Evidence of small cell histology
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Pregnant women are ineligible as the treatment involves unforeseeable risks to the participant and to the embryo or fetus. Patients with childbearing potential must practice appropriate contraception.
  • Patient has enrolled in a clinical trial that specifically does not allow IMRT treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Radiotherapy, Intensity-ModulatedRadiotherapy, Conformal

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Zhongxing Liao, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2007

First Posted

August 24, 2007

Study Start

August 21, 2007

Primary Completion

October 3, 2018

Study Completion

October 3, 2018

Last Updated

October 5, 2018

Record last verified: 2018-10

Locations

US(1)