Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Internal radiation therapy shows promise in pilot study for multiple cancers

NCT ID NCT00924027

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

43 people

The number who actually took part.

Started

Apr 2009

Finished

Jul 2025

Lead sponsor

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

Anyone

Healthy volunteers

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

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Biliary cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.