NCT00178230

Brief Summary

This study is being conducted by the University of Rochester Cancer Center to determine the levels of cytokines in the blood, and to determine if blood levels of these cytokines are related to the side effects of radiation therapy combined with other treatments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 1996

Longer than P75 for all trials

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

March 15, 1996

Completed
9.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2013

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

17.7 years

First QC Date

September 12, 2005

Last Update Submit

June 9, 2017

Conditions

Lung Neoplasms

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving radiation therapy for lung cancer combined with surgery either pre or post RT to the chest for lung cancer not associated with atelectasis, pleural effusion.

You may qualify if:

  • Patients receiving radiation therapy for lung cancer combined with surgery either pre or post RT to the chest for lung cancer not associated with atelectasis, pleural effusion.
  • Patients receiving HDR Brachytherapy for lung cancer.
  • Patients receiving concomitant radiation and interferon therapy for lung cancer.
  • Patients receiving concomitant chemotherapy and radiation for lung cancer. Prior drug therapy does not make patients ineligible.
  • Karnofsky ≥ 70 %.
  • There are no age restrictions.
  • Acceptable bone marrow function - WBC 2 3000/mm3, platelet count \> 100,000, hematocrit ≥ 33%, hemoglobin ≥ 11 gms/dl.
  • Life expectancy \> 6 months.
  • Patients must sign informed consent meeting all federal and institutional guidelines.

You may not qualify if:

  • Patients not meeting eligibility criteria stated above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester, Dept. Radiation Oncology

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Yuhchyau Chen, MD, Ph.D

    Universtiy of Rochester, Dept of Radiation Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Proffessor

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

March 15, 1996

Primary Completion

November 25, 2013

Study Completion

November 25, 2013

Last Updated

June 14, 2017

Record last verified: 2017-06

Locations

US(1)