A Study of Patients Receiving High-Dose Rate Brachytherapy

NCT00924027 | Completed Phase 2 Results FDA Device

• 2 other identifiers: 09010009-C-0100
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Radiation; Cancer; HDR; Brachytherapy; Training

Outcome Measures

Primary Outcomes (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.

  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)

• Number of Prostate Participants With Local Control

  Assessed at 12 months after radiation

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

  Assessed at 12 months after radiation

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

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

• Number of Participants Accrued Who Received Brachytherapy Each Year

  Approximately 16 years

Other Outcomes (2)

• Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria (CTC) v3.0

  Assessed at 12 months after radiation

• Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Radiation Therapy Oncology Group (RTOG)

  Assessed at 12 months after radiation

Study Arms (1)

1/Radiation Therapy

EXPERIMENTAL

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

Radiation: High Dose Radiation (HDR) Brachytherapy; Diagnostic Test: MRI; Diagnostic Test: CT; Diagnostic Test: PET Scan

Interventions

High Dose Radiation (HDR) Brachytherapy 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.

Also known as: HDR Brachytherapy

1/Radiation Therapy

MRI DIAGNOSTIC_TEST

When deemed necessary.

Also known as: Magnetic Resonance Imaging

1/Radiation Therapy

CT DIAGNOSTIC_TEST

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

Also known as: Computed Tomography

1/Radiation Therapy

PET Scan DIAGNOSTIC_TEST

When deemed necessary.

Also known as: Positron Emission Tomography

1/Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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:
• \. 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 10791524 BACKGROUND

• 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.

  PMID: 15940068 BACKGROUND

• 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.

  PMID: 7635767 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms; Esophageal Neoplasms; Prostatic Neoplasms; Biliary Tract Neoplasms; Neoplasms

Interventions

Radiation; Brachytherapy; Magnetic Resonance Imaging; Tomography, X-Ray Computed; Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Biliary Tract Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena; Radiotherapy; Therapeutics; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Interpretation, Computer-Assisted; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography, Emission-Computed; Radionuclide Imaging; Diagnostic Techniques, Radioisotope

Results Point of Contact

• Title: Dr. Deborah E. Citrin
• Organization: National Cancer Institute

citrind@mail.nih.gov

240-760-6206

Study Officials

• Deborah E Citrin, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: June 17, 2009
• First Posted: June 18, 2009
• Study Start: April 14, 2009
• Primary Completion: May 28, 2024
• Study Completion: July 24, 2025
• Last Updated: September 5, 2025
• Results First Posted: September 24, 2024

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.
• Access Criteria: Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).

Locations

US (1)