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New treatment option for Gynecologic Cancer
Official title Cs-131LDR Brachytherapy for Organ-Preserving Irradiation for Recurrent Cervical and Endometrial Cancer
ClinicalTrials.gov ID: NCT07631572
What this study is testing
- What it's testing
- This clinical trial studies how well cesium-131 low-dose rate interstitial brachytherapy works as an organ-preserving radiation technique in the treatment of patients with cervical and endometrial cancer that has come back in the vagina after a period of improvement following pelvic radiation therapy (vaginal recurrence). In cervical and endometrial cancer patients with vaginal recurrence following pelvic radiation therapy, the only curative option involves a major surgical procedure which removes all the contents of the pelvic cavity, such as the uterus, cervix, bladder, rectum, vagina, and vulva.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Patients must have histologically or cytologically confirmed vaginal recurrence of endometrial (endometrioid adenocarcinoma, uterine serous...
- Patients must have vaginal recurrence that is amenable to cesium implant for salvage
- Patients must have a vaginal lesion that is measurable according to RECIST 1.1 criteria; that is, at least 1 cm upon measurement by CT, or MRI if the...
- Patients must have previous external beam radiation treatment to the pelvis for the uterine cervix or endometrial malignancy that has recurred to be...
- Gynecologic Oncology Group performance status of 0, 1, or 2 (see Appendix A).
You likely can't join if
- Patients who have another concurrent, active invasive malignancy or have had a prior invasive malignancy diagnosed within the last three years, with...
- Patients who have metastatic or regional lymph node metastases who have radiographic evidence of disease at time of study enrollment. Patients who...
- Receipt of epoetin alpha (Procrit, Epogen) within 1 month of study screening.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cesium-131 implant or other agents used in this...
- Pregnant women are excluded from this study because radiation is a known teratogen. Patient must agree to use two forms of birth control if they are...
See the full eligibility criteria
- Patients must have histologically or cytologically confirmed vaginal recurrence of endometrial (endometrioid adenocarcinoma, uterine serous, carcinosarcoma, clear cell) or cervical (squamous, adenosquamous, or...
- Patients must have vaginal recurrence that is amenable to cesium implant for salvage
- Patients must have a vaginal lesion that is measurable according to RECIST 1.1 criteria; that is, at least 1 cm upon measurement by CT, or MRI if the patient cannot have a CT with contrast or lesion is not visualized on...
- Patients must have previous external beam radiation treatment to the pelvis for the uterine cervix or endometrial malignancy that has recurred to be eligible for this study, so long as the prior exposure does not exceed...
- Gynecologic Oncology Group performance status of 0, 1, or 2 (see Appendix A).
- There are no minimum organ/marrow function requirements because patients will not be receiving systemic therapy.
- Ability to understand and the willingness to sign a written informed consent document.
- Patients who have another concurrent, active invasive malignancy or have had a prior invasive malignancy diagnosed within the last three years, with the following two exceptions: [a] non-melanoma skin cancer and/or [b]...
- Patients who have metastatic or regional lymph node metastases who have radiographic evidence of disease at time of study enrollment. Patients who have had metastasis or lymph nodes previously treated without...
- Receipt of epoetin alpha (Procrit, Epogen) within 1 month of study screening.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cesium-131 implant or other agents used in this study.
- Pregnant women are excluded from this study because radiation is a known teratogen. Patient must agree to use two forms of birth control if they are of child-bearing potential. For this reason, women of child-bearing...
The study team makes the final eligibility decision.
Where it's taking place
- Lexington, Kentucky, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lexington, Kentucky, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.