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Frailty Study of Older Adults Getting Chemotherapy and Radiation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01808833
Recruitment Status : Terminated
First Posted : March 11, 2013
Last Update Posted : January 29, 2014
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Brief Summary:
The investigators hypothesize that frailty assessment prior to concurrent chemotherapy and radiation therapy in the elderly will predict treatment-related toxicity and morbidity and that such assessment at serial time points will help improve treatment and outcomes for these patients.

Condition or disease

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Study Type : Observational
Actual Enrollment : 4 participants
Time Perspective: Cross-Sectional
Official Title: A Pilot Trial of Frailty Assessment in Older Adults (Age 70 >) Requiring Concurrent Chemotherapy Plus Radiation Therapy for Cancer (CTRC# 12-22)
Study Start Date : February 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Frail patients
Non-frail patients

Primary Outcome Measures :
  1. Change in frailty assessment due chemotherapy toxicity [ Time Frame: Subjects will be followed for frailty measures during standard of care chemotherapy treatment, an average of 8 weeks per treatment ]
    Validated frailty measures, and geriatric assessment tools will be used.

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Age >70 years undergoing concurrent standard of care chemotherapy plus radiation therapy.

Inclusion Criteria:

  • Patients must have one of the following histologically or cytologically confirmed cancers: lung cancer, head and neck cancer, gastric cancer, anal cancer, rectal cancer, cervix cancer, or bladder cancer, and must have appropriate indications for the use of standard concurrent chemotherapy plus radiation therapy as defined in the NCCN (National Comprehensive Cancer Network) Guidelines for each of these specific organ-sites.
  • Age >70 years.
  • ECOG (Easter Cooperative Oncology Group) performance status of 0, 1 or 2.
  • Life expectancy Tables showing upper, middle, and lower quartiles of life expectancy for women and men age 70 and older should be used and life expectancy should be estimated to be of sufficient to justify the use of concurrent chemotherapy plus radiation for each organ site and indication.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered to baseline from adverse events due to agents administered more than 4 weeks earlier.
  • Patients who are receiving any investigational agents.
  • Patients with known distant site metastases (M1 disease) or brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients who have a history of one or more other concurrent cancers besides the cancer for which concurrent chemotherapy plus radiation therapy is considered are ineligible only if the other cancer or cancers are being considered for treatment or are actively being treated.
  • Patients carrying a pre-existing diagnosis of HIV/AIDS and are on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with chemotherapy. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
  • Patients with any standard contraindication to chemotherapy or radiation therapy are ineligible.
  • Transplant recipient patients on immune-suppressant agents are ineligible due to increased risk of infection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01808833

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United States, Texas
Cancer Therapy and Research Center at UTHSCSA
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
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Principal Investigator: Anand Karnad, MD University of Texas
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Responsible Party: The University of Texas Health Science Center at San Antonio Identifier: NCT01808833    
Other Study ID Numbers: CTRC 12-22
First Posted: March 11, 2013    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: January 2014
Keywords provided by The University of Texas Health Science Center at San Antonio:
Geriatric oncology
Additional relevant MeSH terms:
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Pathologic Processes