Non-ovarian Gynecological CancersNCT02003430
Radiation Adherence/Toxicity in Patients With Non-Ovarian Gynecological Cancers
An observational study of Non-ovarian Gynecological Cancers, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to investigate the association between the Independent Activities of Daily Living (I-ADL) component of the Comprehensive Geriatric Assessment (CGA) and poor tolerance to radiation treatment in older and younger patients with non-ovarian gynecological cancers. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Non-ovarian Gynecological Cancers
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Oct 2017
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients age 18 years of age or above with a diagnosis of cervical, vaginal, vulvar, or endometrial cancer with either pelvic radiotherapy or chemoradiotherapy planned as part of standard treatment with curative intent at the Department of Radiation Oncology at UNC Chapel Hill.
Who may be able to join
- ≥Age 18 years (no upper age limit)
- Diagnosis of cervical, vaginal, vulvar, or endometrial cancer with either pelvic radiotherapy or chemoradiotherapy planned as part of standard treatment.
- Consented for receipt of External Beam Radiation Therapy (EBRT) at the University of North Carolina Chapel Hill
- Ability to read English (required for CGA)
- Curative treatment intent as defined by their radiation oncologist
- Negative serum pregnancy test in women of childbearing potential
Who cannot join
- < Age 18 years
- Incurable cancer as defined by their radiation oncologist
- Planned radiation for palliative intent only
- Inability to complete the I-ADL section of the CGA
- Prior radiation to areas targeted by radiotherapy within this study
- Other active, invasive malignancy requiring active ongoing therapy during their radiotherapy with the exception of:
Show all 9Show fewer
- Localized squamous cell carcinoma of the skin
- Basal-cell carcinoma of the skin
- Other malignancies requiring locally ablative therapy only
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Department of Radiation Oncology Clinic
Chapel Hill, North Carolina, 27599
About this study
Official title: Functional Assessment and Radiation Adherence/Toxicity in Older and Younger Patients With Non-Ovarian Gynecological Cancers
The purpose of this study is to investigate the association between the Independent Activities of Daily Living (I-ADL) component of the Comprehensive Geriatric Assessment (CGA) and poor tolerance to radiation treatment in older and younger patients with non-ovarian gynecological cancers.
Read the detailed description
There are little data regarding the impact of functional age on tolerance to radiotherapy for gynecologic cancers. A comprehensive geriatric assessment (CGA) tool which measures functional status (including the Instrumental Activities of Daily Living (I-ADL)), among many other important geriatric related conditions, was developed by Hurria and colleagues. Geriatric assessment variables including functional status predicted for toxicity in older patients receiving chemotherapy and surgery for multiple cancer types., 2 We hypothesize that I-ADL can be used to predict treatment tolerance in patients of all ages receiving pelvic and/or paraaortic region radiation therapy for gynecologic malignancies.
- Conditions
- Non-ovarian Gynecological Cancers
- Keywords
- gynecologic malignancy, non-ovarian gynecological cancer, cervical cancer, vaginal cancer, vulvar cancer, endometrial cancer
- Medical subject headings
- Uterine Cervical Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms, Endometrial Neoplasms
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 |
|---|---|---|
| ≥65 years old | 20 patients greater than or equal to 65 years of age | |
| <65 years old | 20 patients less than 65 years of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-treatment I-ADL dependency
Pre-treatment I-ADL dependency is defined as scoring less than 14 on the I-ADL scale of the CGA.
Measured: Pre-treatment
Secondary outcomes (1)
Poor adherence to treatment
Poor adherence to treatment is defined by at least one of the following:
- > 3 day treatment delay secondary to treatment related toxicity during radiation therapy.
- Hospitalization secondary to treatment related toxicity during or up to 4-8 weeks post radiation therapy.
- Unplanned dose reductions in either radiation or concurrent chemotherapy secondary to treatment related toxicity during radiation therapy
- Unplanned change in concurrent chemotherapy regimen secondary to treatment related toxicity during radiation therapy.
Measured: During or 4-8 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-ovarian Gynecological CancersStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahesh Varia, MD, ChB, Principal investigator, Department of Radiation Oncology, University of North Carolina Chapel HillNoam VanderWalde, MD, Study director, Department of Radiation Oncology, Unverisity of North Carolina Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003430
- Sponsor's protocol ID
- LCCC1321
- Status last verified
- Jan 2018
- First submitted
- 18 Nov 2013
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Assessment and Radiation Adherence/Toxicity in Older and Younger Patients With Non-Ovarian Gynecological Cancers
- ClinicalTrials.gov ID
- NCT02003430
- Acronym / sponsor ID
- LCCC1321
- Conditions
- Non-ovarian Gynecological Cancers
- Keywords
- gynecologic malignancy, non-ovarian gynecological cancer, cervical cancer, vaginal cancer, vulvar cancer, endometrial cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 6 Dec 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 purpose of this study is to investigate the association between the Independent Activities of Daily Living (I-ADL) component of the Comprehensive Geriatric Assessment (CGA) and poor tolerance to radiation treatment in older and younger patients with non-ovarian gynecological cancers.
Detailed description
There are little data regarding the impact of functional age on tolerance to radiotherapy for gynecologic cancers. A comprehensive geriatric assessment (CGA) tool which measures functional status (including the Instrumental Activities of Daily Living (I-ADL)), among many other important geriatric related conditions, was developed by Hurria and colleagues. Geriatric assessment variables including functional status predicted for toxicity in older patients receiving chemotherapy and surgery for multiple cancer types., 2 We hypothesize that I-ADL can be used to predict treatment tolerance in patients of all ages receiving pelvic and/or paraaortic region radiation therapy for gynecologic malignancies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ≥65 years old | – | –20 patients greater than or equal to 65 years of age |
| <65 years old | – | –20 patients less than 65 years of age |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients age 18 years of age or above with a diagnosis of cervical, vaginal, vulvar, or endometrial cancer with either pelvic radiotherapy or chemoradiotherapy planned as part of standard treatment with curative intent at the Department of Radiation Oncology at UNC Chapel Hill.
Key inclusion criteria (6 listed)
- ≥Age 18 years (no upper age limit)
- Diagnosis of cervical, vaginal, vulvar, or endometrial cancer with either pelvic radiotherapy or chemoradiotherapy planned as part of standard treatment.
- Consented for receipt of External Beam Radiation Therapy (EBRT) at the University of North Carolina Chapel Hill
- Ability to read English (required for CGA)
- Curative treatment intent as defined by their radiation oncologist
Key exclusion criteria (9 listed)
- < Age 18 years
- Incurable cancer as defined by their radiation oncologist
- Planned radiation for palliative intent only
- Inability to complete the I-ADL section of the CGA
- Prior radiation to areas targeted by radiotherapy within this study
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
Pre-treatment I-ADL dependency
Time frame: Pre-treatment
Pre-treatment I-ADL dependency is defined as scoring less than 14 on the I-ADL scale of the CGA.
1 secondary outcome
Poor adherence to treatment
Time frame: During or 4-8 weeks post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
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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.
Mahesh Varia, MD, ChB principal investigator
Department of Radiation Oncology, University of North Carolina Chapel Hill
Noam VanderWalde, MD study director
Department of Radiation Oncology, Unverisity of North Carolina Chapel Hill
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 Non-ovarian Gynecological Cancers, run by UNC Lineberger Comprehensive Cancer Center 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 24 Jan 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pre-treatment I-ADL dependency (time frame: Pre-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 24 Jan 2018.