A Study of Patients Receiving High-Dose Rate Brachytherapy

NCT ID: NCT00924027

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-14
• Study Completion Date: 2025-07-24

Brief 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.
• 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.

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.

Conditions

Cervical Cancer; Endometrial Cancer; Esophageal Cancer; Prostate Cancer; Biliary Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1/Radiation Therapy

Radiation therapy given as high dose radiation (HDR) Brachytherapy.

Group Type: EXPERIMENTAL

High Dose Radiation (HDR) Brachytherapy

Intervention Type: RADIATION

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.

MRI

Intervention Type: DIAGNOSTIC_TEST

When deemed necessary.

CT

Intervention Type: DIAGNOSTIC_TEST

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

PET Scan

Intervention Type: DIAGNOSTIC_TEST

When deemed necessary.

Interventions

High Dose Radiation (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.

Intervention Type: RADIATION

MRI

When deemed necessary.

Intervention Type: DIAGNOSTIC_TEST

CT

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

Intervention Type: DIAGNOSTIC_TEST

PET Scan

When deemed necessary.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

HDR Brachytherapy; Magnetic Resonance Imaging; Computed Tomography; Positron Emission Tomography

Eligibility Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Deborah Citrin, M.D.

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah E Citrin, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 10791524 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15940068 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7635767 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2009-C-0100.html

NIH Clinical Center Detailed Web Page

Other Identifiers

09-C-0100

Identifier Type: -

Identifier Source: secondary_id

090100

Identifier Type: -

Identifier Source: org_study_id