Endometrial CarcinomaNCT00165126
Dosimetric Analysis of Vaginal Cuff Brachytherapy in Endometrial Carcinoma
An observational study of Endometrial Carcinoma and Cervix Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The purpose of this study is to investigate the effect of certain variables such as the fullness of the patients bladder and the position of the treatment applicator on the dose of radiation that other organs such as the bladder and the rectum receive during radiation treatment for endometrial carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Endometrial Carcinoma, Cervix Cancer, Carcinoma of the Uterus
- What is being tested?
- Radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2004to Jul 2008
- 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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with carcinoma of the uterus, post-hysterectomy stages I-IVA or vaginal cuff recurrence or post-hysterectomy cervix cancer stages IA or IB or post hysterectomy vaginal cancer stage I that will be undergoing radiation therapy.
Who may be able to join
- Histologic documentation of carcinoma of the uterus, post-hysterectomy stages I-IVA or vaginal cuff recurrence. Or post-hysterectomy cervix cancer stages IA or IB or post hysterectomy vaginal cancer stage I.
- ECOG performance status of less than or equal to 2
- 18 years of age or older
Who cannot join
- Distant metastases
- Inoperable disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
The purpose of this study is to investigate the effect of certain variables such as the fullness of the patients bladder and the position of the treatment applicator on the dose of radiation that other organs such as the bladder and the rectum receive during radiation treatment for endometrial carcinoma.
Read the detailed description
- This study is separated into 2 phases. In phase 1, patients will be asked to have their bladder full for the second planned insertion of the brachytherapy applicator and empty for the third insertion. For phase 2, the effect of cylinder angle on normal tissue dosimetry will be investigated. Of the two bladder states assessed in phase 1 (empty or full), the one deemed to give the lower dose to the total amount of bladder tissue will be considered the standard and applied to all patients in phase 2.
- In phase 1, to standardize bladder filling, patients will be asked to empty their bladder, then to drink 32 oz of water one and a half hours before the CT scan. The patient will undergo a treatment-planning scan after the brachytherapy cylinder is inserted and before brachytherapy treatment.
- In phase 2, patients will be asked to fill or empty their bladder according to the results of phase 1. The vaginal cylinder will be placed horizontally for the second treatment. The cylinder will then be angled at a specific angle for the subsequent treatment.
- A history and physical exam will be performed within 2 weeks of study entry, then at 14 days, 90 days, and 180 days following the completion of therapy.
- Being tested
- Radiation therapy
- Keywords
- dosimetric analysis, vaginal cuff brachytherapy
- Medical subject headings
- Endometrial Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation therapyProcedure or surgery
Given as standard therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionJan 2006
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CarcinomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Investigators
- Akila Viswanathan, MD, MPH, Principal investigator, Dana-Farber Cancer Institute/Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00165126
- Sponsor's protocol ID
- 03-315
- Status last verified
- Oct 2009
- First submitted
- 9 Sep 2005
- Last updated
- 2 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosimetric Analysis of Vaginal Cuff Brachytherapy in Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT00165126
- Acronym / sponsor ID
- 03-315
- Keywords
- dosimetric analysis, vaginal cuff brachytherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- Jan 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 14 Sep 2005 (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 effect of certain variables such as the fullness of the patients bladder and the position of the treatment applicator on the dose of radiation that other organs such as the bladder and the rectum receive during radiation treatment for endometrial carcinoma.
Detailed description
- This study is separated into 2 phases. In phase 1, patients will be asked to have their bladder full for the second planned insertion of the brachytherapy applicator and empty for the third insertion. For phase 2, the effect of cylinder angle on normal tissue dosimetry will be investigated. Of the two bladder states assessed in phase 1 (empty or full), the one deemed to give the lower dose to the total amount of bladder tissue will be considered the standard and applied to all patients in phase 2.
- In phase 1, to standardize bladder filling, patients will be asked to empty their bladder, then to drink 32 oz of water one and a half hours before the CT scan. The patient will undergo a treatment-planning scan after the brachytherapy cylinder is inserted and before brachytherapy treatment.
- In phase 2, patients will be asked to fill or empty their bladder according to the results of phase 1. The vaginal cylinder will be placed horizontally for the second treatment. The cylinder will then be angled at a specific angle for the subsequent treatment.
- A history and physical exam will be performed within 2 weeks of study entry, then at 14 days, 90 days, and 180 days following the completion of therapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with carcinoma of the uterus, post-hysterectomy stages I-IVA or vaginal cuff recurrence or post-hysterectomy cervix cancer stages IA or IB or post hysterectomy vaginal cancer stage I that will be undergoing radiation therapy.
Key inclusion criteria (3 listed)
- Histologic documentation of carcinoma of the uterus, post-hysterectomy stages I-IVA or vaginal cuff recurrence. Or post-hysterectomy cervix cancer stages IA or IB or post hysterectomy vaginal cancer stage I.
- ECOG performance status of less than or equal to 2
- 18 years of age or older
Key exclusion criteria (2 listed)
- Distant metastases
- Inoperable disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation therapyGiven as standard therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 2 Nov 2009.
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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.
Akila Viswanathan, MD, MPH principal investigator
Dana-Farber Cancer Institute/Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Carcinoma and Cervix Cancer, run by Dana-Farber Cancer Institute at 2 sites 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 3 inclusion and 2 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 2 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 2 Nov 2009.