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Cervical CancerPhase 2NCT00924027

A Study of Patients Receiving High-Dose Rate Brachytherapy

A Phase 2 study testing High Dose Radiation (HDR) Brachytherapy, MRI and CT in people with Cervical Cancer and Endometrial Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
High Dose Radiation (HDR) Brachytherapy, MRI and CT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteUnited States
Study dates
14 Apr 2009to 24 Jul 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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):
Show all 22Show fewer
  • 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.

Who cannot join

  • Cognitively impaired participants who cannot give informed consent.
  • 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)
  • Pregnant or breast-feeding females are excluded because of the potential mutagenic effects on a developing fetus or newborn.
  • 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 who are in the estimation of the PI, deemed unable or unlikely to adhere to protocol treatment.
Show all 19Show fewer
  • 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)
  • 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.
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: A Pilot Study of High Dose Rate Brachytherapy in The Radiation Oncology Branch

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.
Read more

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.
Read the detailed description

BACKGROUND:

  • High dose rate brachytherapy (HDR) is a challenging technique utilized in many malignancies in order to deliver a high dose of radiation therapy to a tumor in a conformal fashion with a rapid dose fall-off with the objective of sparing normal surrounding tissue
  • HDR therapy has been targeted to particular subsites as an integral part of either definitive management or palliation for malignancy-related symptoms.

OBJECTIVES:

  • The primary objective is to determine the quality of high dose rate brachytherapy implants performed in the radiation oncology branch. An implant will be adequate if 90% of the GTV receives 90% of the dose prescribed and 80% of the Gross Tumor Volume (GTV) receives 85% of the prescribed dose. An implant will be inadequate if the above dose limitations are not met.
  • To evaluate local control and late toxicity rates following brachytherapy at the NCI ROB
  • To increase the flow of oncology participants requiring brachytherapy to the National Cancer Institute (NCI) Radiation Oncology Branch (ROB), as these participants lend themselves to special study and have unique educational value for the purpose of educating nurses, medical students, residents, physicists, clinical fellows, and physicians.

ELIGIBILITY:

-Participants with cancer who could potentially benefit from the use of high dose rate brachytherapy as a component of their treatment.

DESIGN:

  • Participants will undergo appropriate work-up and clinical evaluation to determine if high-dose brachytherapy would be beneficial in either primary treatment or palliation of their disease. Participants will be treated with high-dose brachytherapy appropriately sequenced with other modalities in their treatment regimen. This treatment will be administered in accordance with standard radiation oncology practice and per the ABS (American Brachytherapy Society) guidelines.
  • The participants disease status and toxicity outcomes will be documented for a 12-month period at 3-months intervals.
Being tested
High Dose Radiation (HDR) Brachytherapy, MRI, CT, PET Scan
Keywords
Radiation, Cancer, HDR, Brachytherapy, Training
Medical subject headings
Uterine Cervical Neoplasms, Endometrial Neoplasms, Esophageal Neoplasms, Prostatic Neoplasms, Biliary Tract Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Dose Radiation (HDR) BrachytherapyRadiation

    Also called HDR Brachytherapy

    Brachytherapy, the placement of a radioactive source close to a tumor, is a well-established part of the treatment of many malignancies, both for palliative and definitive applications. High dose brachytherapy is useful in many malignancies in order to deliver a high dose of radiation therapy to tumor in a conformal fashion with a rapid dose fall-off with the objective of sparing normal surrounding tissue.

  • MRIDiagnostic test

    Also called Magnetic Resonance Imaging

    When deemed necessary.

  • CTDiagnostic test

    Also called Computed Tomography

    Obtained based on the sites of target, as clinical situation dictates and at each follow-up to determine local control.

  • PET ScanDiagnostic test

    Also called Positron Emission Tomography

    When deemed necessary.

Study groups in NCT00924027
Study groupRoleWhat they receive
1/Radiation TherapyExperimentalRadiation therapy given as high dose radiation (HDR) Brachytherapy.
Receives: Radiation: High Dose Radiation (HDR) Brachytherapy; Diagnostic Test: MRI; Diagnostic Test: CT; Diagnostic Test: PET Scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Had Adequate High-Quality Brachytherapy Implants Reported Per Strata (Four Body Sites) and Combined Overall

    An implant is adequate if 90% of the Gross Tumor Volume (GTV) receives 90% of the dose prescribed and 80% of the Clinical Tumor Volume (CTV) receives 85% of the prescribed dose. An implant is inadequate if the above criteria is not met. A GTV only applies to certain disease sites such as gynecologic cancer that have not been removed by surgery and CTV applies to prostate or gynecologic cancer that have been removed surgically.

    Measured: All participants were assessed 1 week after last dose of high dose radiation (HDR) brachytherapy, an average of 1 week (no range).

Secondary outcomes (4)

  1. Number of Prostate Participants With Local Control

    Local control of the prostate is defined as Biochemical recurrence. Biochemical recurrence is a serum prostatic specific antigen (PSA) more than 2 ng/dL above the post brachytherapy nadir, measured by at least 2 PSA measurements separated by 1 month, and the National Comprehensive Cancer Network (NCCN) guidelines.

    Measured: Assessed at 12 months after radiation

  2. Number of Participants With Local Control Reported Per Strata (Body Sites) and Combined Overall

    Local control is defined as Complete Response (CR), Partial Response (PR) or Stable Disease (SD) of the treated site. In diseases where targets can be imaged, response will be measured using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria only for local sites. Complete Response is disappearance of the target lesion. Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of the target lesion taking into account the baseline sum LD. Stable Disease does not qualify for CR, PR, or progression. Progression is interval increase in the maximal dimension of the target lesion. Scoring of local control at each treated site will be based on Response Evaluation Criteria in Solid Tumor (RECIST) criteria. Each site will be scored separately (Only for local sites) and the number of participants with CR, PR, SD will be determined.

    Measured: Assessed at 12 months after radiation

  3. Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall

    The Radiation Therapy Oncology Group (RTOG)/European Organization for Research and Treatment of Cancer (EORTC) Radiation Morbidity Scoring Scheme was used to score late toxicity following brachytherapy. Late toxicities are graded 0-5. Grade 0 is no symptoms. Grade 1 is mild/slight symptoms. Grade 2 is moderate. Grade 3 is severe. Grade 4 is severe/life-threatening. And Grade 5 is toxicity related to death.

    Measured: Date treatment consent signed to date off study, approximately 159 months and 21 days.

  4. Number of Participants Accrued Who Received Brachytherapy Each Year

    To help understand and increase the flow of participants receiving brachytherapy, the number of participants who received brachytherapy each year are reported.

    Measured: Approximately 16 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2009 (estimated)
  2. Study start14 Apr 2009
  3. Primary completion28 May 2024
  4. Study completion24 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00924027
Sponsor's protocol ID
090100
Other IDs
09-C-0100
Status last verified
Aug 2025
First submitted
17 Jun 2009
Last updated
5 Sep 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.

Publications

  • Creutzberg CL, van Putten WL, Koper PC, Lybeert ML, Jobsen JJ, Warlam-Rodenhuis CC, De Winter KA, Lutgens LC, van den Bergh AC, van de Steen-Banasik E, Beerman H, van Lent M. Surgery and postoperative radiotherapy versus surgery alone for patients with stage-1 endometrial carcinoma: multicentre randomised trial. PORTEC Study Group. Post Operative Radiation Therapy in Endometrial Carcinoma. Lancet. 2000 Apr 22;355(9213):1404-11. doi: 10.1016/s0140-6736(00)02139-5.

    PubMed 10791524

  • Kocak Z, Ozkan H, Adli M, Garipagaoglu M, Kurtman C, Cakmak A. Intraluminal brachytherapy with metallic stenting in the palliative treatment of malignant obstruction of the bile duct. Radiat Med. 2005 May;23(3):200-7.

    PubMed 15940068

  • Perez CA, Grigsby PW, Castro-Vita H, Lockett MA. Carcinoma of the uterine cervix. I. Impact of prolongation of overall treatment time and timing of brachytherapy on outcome of radiation therapy. Int J Radiat Oncol Biol Phys. 1995 Jul 30;32(5):1275-88. doi: 10.1016/0360-3016(95)00220-S.

    PubMed 7635767

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing High Dose Radiation (HDR) Brachytherapy, MRI and CT in people with Cervical Cancer and Endometrial Cancer, run by National Cancer Institute (NCI) at 1 site 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 22 inclusion and 19 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 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Number of Participants Who Had Adequate High-Quality Brachytherapy Implants Reported Per Strata (Four Body Sites) and Combined Overall (time frame: All participants were assessed 1 week after last dose of high dose radiation (HDR) brachytherapy, an average of 1 week (no range).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00924027, which also lists 3 linked publications.

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 5 Sep 2025.

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