CancerNCT01808833
Frailty Study of Older Adults Getting Chemotherapy and Radiation Therapy
An observational study of Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Cancer
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Age >70 years undergoing concurrent standard of care chemotherapy plus radiation therapy.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Therapy and Research Center at UTHSCSA
San Antonio, Texas, 78229
About this study
Official title: A Pilot Trial of Frailty Assessment in Older Adults (Age 70 >) Requiring Concurrent Chemotherapy Plus Radiation Therapy for Cancer (CTRC# 12-22)
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.
- Conditions
- Cancer
- Keywords
- Frailty, Geriatric oncology
- Medical subject headings
- Neoplasms, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Frail patients | Not described | |
| Non-frail patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frailty assessment due chemotherapy toxicity
Validated frailty measures, and geriatric assessment tools will be used.
Measured: Subjects will be followed for frailty measures during standard of care chemotherapy treatment, an average of 8 weeks per treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study startFeb 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anand Karnad, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808833
- Sponsor's protocol ID
- CTRC 12-22
- Status last verified
- Jan 2014
- First submitted
- 1 Nov 2012
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Frailty Assessment in Older Adults (Age 70 >) Requiring Concurrent Chemotherapy Plus Radiation Therapy for Cancer (CTRC# 12-22)
- ClinicalTrials.gov ID
- NCT01808833
- Acronym / sponsor ID
- CTRC 12-22
- Conditions
- Cancer
- Keywords
- Frailty, Geriatric oncology
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 11 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frail patients | – | – |
| Non-frail patients | – | – |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Age >70 years undergoing concurrent standard of care chemotherapy plus radiation therapy.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anand Karnad, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2014.