Internal radiation therapy shows promise in pilot study for multiple cancers
NCT ID NCT00924027
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This pilot study tested high dose rate brachytherapy, a type of internal radiation, in 43 patients with cervical, endometrial, esophageal, prostate, or biliary cancer. The goal was to see if the radiation implants could deliver the planned dose accurately. Participants received brachytherapy as part of their treatment and were followed for up to a year. The study focused on implant quality and local tumor control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- High Dose Rate Brachytherapy (internal radiation)
- What this could lead to
- If successful, this could help refine brachytherapy techniques to better target tumors while sparing healthy tissue, potentially improving cancer control.
- What could go wrong
- This is a small, early-phase pilot study (43 participants) focused on procedure quality, not survival. Results may not apply to all patients or cancer types.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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43 people
The number who actually took part.
- Started
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Apr 2009
- Finished
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Jul 2025
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: 1. Pathologically confirmed malignancy for which high-dose rate brachytherapy is appropriate as a component of their therapeutic regimen. 2. Age greater than 18 years of age. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 4. 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. 5. 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. 6. 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. EXCLUSION CRITERIA: 1. Cognitively impaired participants who cannot give informed consent. 2. Participants currently receiving concurrent investigational chemotherapeutic agents. 3. 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) 4. Pregnant or breast-feeding females are excluded because of the potential mutagenic effects on a developing fetus or newborn. 5. 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. 6. Participants who are in the estimation of the PI, deemed unable or unlikely to adhere to protocol treatment. 7. 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) 8. 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. 9. 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: * distant metastases * lymph node metastases
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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