NCT00924027CompletedPhase 2
A Study of Patients Receiving High-Dose Rate Brachytherapy
A Pilot Study of High Dose Rate Brachytherapy in The Radiation Oncology Branch
Source: ClinicalTrials.gov · Last updated 5 Sept 2025
Brief summary (registry, in English)
Background: * One standard way of giving radiation is to combine external beam treatments with internal brachytherapy treatments, which involve short-range radiation therapy that gives a high dose of radiation directly to a cancer or to the area where cancer cells were removed. * Brachytherapy is done by placing hollow implant device(s) into the area to be treated and then moving a radiation source into each. The type of device depends on the type of cancer and the site to be treated. These devices can range from hollow applicators and needles to balloon-like equipment. Objectives: * To evaluate the quality of the brachytherapy procedure at the National Institutes of Health Radiation Oncology Branch. Eligibility: * Patients with cancer who could potentially benefit from high-dose brachytherapy as part of their treatment. Design: * In conjunction with their existing treatment, patients will be treated with high-dose brachytherapy as determined appropriate for their particular type of cancer and cancer history. * Each treatment will take place in the Radiation Oncology Clinic. * If the patient does not have implant devices, the clinic staff will insert them and check their placement through a computed tomography (CT) scan. * The calculations to determine the appropriate brachytherapy dose will take a few hours; the brachytherapy treatment itself will take between 10 and 30 minutes. * The number of brachytherapy treatments will vary according to the individual needs and requirements of each type of cancer and each patient. * Patients will return to the Radiation Oncology Clinic for follow-up visits at 1, 3, 6, 9, and 12 months after the completion of radiation therapy. Follow-up evaluations will include a medical history and physical examination, assessment of any side effects of radiation therapy, and a repeat of any imaging (i.e., CT, magnetic resonance imaging (MRI), X-ray) that was done at baseline to evaluate the tumor response.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 43 (actual)
- First submitted
- 17 Jun 2009
- Start date
- 14 Apr 2009
- Primary completion date
- 28 May 2024
- Lead sponsor
- National Cancer Institute (NCI)
- NCT number
- NCT00924027
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 43
- From 14 Apr 2009 to the primary completion date, 28 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants currently receiving concurrent investigational chemotherapeutic agents.
- Participants receiving concomitant chemotherapy administration in the 5 days preceding brachytherapy (except for gynecological cancer patients who may have received concurrent chemotherapy as a component of their treatment regimen)
- Any participant or tumor/anatomical factors that may prevent brachytherapy apparatus from being properly and safely inserted and positioned and from radiation therapy being administered per American Brachytherapy Society (ABS) guidelines.
Other illness
- Clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), which in the judgment of the Principal or Associate Investigator would compromise the participant s ability to tolerate this therapy or are likely to interfere with the study procedures or results.
- Participants whose malignancy has one or more of the following site-specific criteria disqualifying them from the study:
- 1\. Breast cancer:
- Participants inappropriate for standard breast conservation therapy (Multicentric disease, inability to achieve clear margins);
- male participants with breast cancer
- autoimmune disorders, including systemic lupus erythematosus (SLE), Scleroderma, etc.
- distant metastases;
- 2\. Prostate cancer:
Lab values
- Abnormal bleeding times or active anti-coagulation therapy.
- platelets less than 100,000 per mm(3)
- Prothrombin time (PT)/Partial thromboplastin time (PTT) greater than 1.5 the upper normal limit (UNL)
Other
- Cognitively impaired participants who cannot give informed consent.
- Pregnant or breast-feeding females are excluded because of the potential mutagenic effects on a developing fetus or newborn.
- Participants who are in the estimation of the PI, deemed unable or unlikely to adhere to protocol treatment.
- distant metastases
- lymph node metastases
Criteria the registry did not label
- INCLUSION CRITERIA:
- Pathologically confirmed malignancy for which high-dose rate brachytherapy is appropriate as a component of their therapeutic regimen.
- Age greater than 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Participant must have a primary medical or surgical oncologist in the community or at National Cancer Institute (NCI) who is willing to collaborate with the Radiation Oncology Branch (ROB) staff in the clinical management of the participant.
- Participants of childbearing or child- fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study.
- Site-specific inclusion criteria (any one or more of the following):
- Gynecologic Cancers:
- Endometrial cancer
- Participants at a higher risk of recurrence (because of either grade, myometrial invasion, lymphatic vascular space invasion, tumor size, lymph node status, tumor extension, presence or absence of surgical staging)
- Participants who have suffered a recurrence at the vaginal cuff
- Participants who are unable to undergo surgery and must have treatment for an inoperable primary endometrial cancer.
- Cervical cancer
- Participants who are unable to undergo surgery and must have treatment for an inoperable primary cervical cancer.
- Participants with locally advanced cervical cancer in whom brachytherapy will be integrated as a boost to external beam radiation either in a palliative or curative setting (definitive or post-operative setting).
- Lung cancer
- Participants with an endobronchial component causing symptoms
- Participants who cannot undergo resection because of poor lung function or distant lung metastasis
- Breast cancer
- Infiltrating ductal carcinoma or ductal carcinoma in-situ (DCIS), stage T0, T1, and T2 less than or equal to 3.0 cm, N0 and M0,
- Participants benefiting from high dose radiation (HDR) as either as a boost or accelerated partial breast irradiation regimen.
- Prostate Cancer
- -Participants with localized prostate cancer (T1b-T3b) in whom brachytherapy will be integrated as a boost to external beam radiation or used as monotherapy for definitive management.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.