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A Pilot Trial of Frailty Assessment in Older Adults (Age 70 >) Requiring Concurrent Chemotherapy Plus Radiation Therapy for Cancer (CTRC# 12-22)

70 Years
Open (Enrolling)

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Trial Information

A Pilot Trial of Frailty Assessment in Older Adults (Age 70 >) Requiring Concurrent Chemotherapy Plus Radiation Therapy for Cancer (CTRC# 12-22)

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

- 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

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

- Patients with any standard contraindication to chemotherapy or radiation therapy are

- Transplant recipient patients on immune-suppressant agents are ineligible due to
increased risk of infection.

Type of Study:


Study Design:

Time Perspective: Cross-Sectional

Outcome Measure:

Change in frailty assessment due chemotherapy toxicity

Outcome Description:

Validated frailty measures, and geriatric assessment tools will be used.

Outcome Time Frame:

Subjects will be followed for frailty measures during standard of care chemotherapy treatment, an average of 8 weeks per treatment

Safety Issue:


Principal Investigator

Anand Karnad, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Texas


United States: Institutional Review Board

Study ID:

CTRC 12-22



Start Date:

February 2012

Completion Date:

February 2016

Related Keywords:

  • Cancer
  • Frailty
  • Geriatric oncology



Cancer Therapy and Research Center at UTHSCSA San Antonio, Texas  78229