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

  • STATUS
    Recruiting
  • End date
    Nov 1, 2025
  • participants needed
    112
  • sponsor
    National Cancer Institute (NCI)
Updated on 19 September 2022
ct scan
cancer
carcinoma
breast cancer
lung cancer
treatment regimen
x-rays
metastasis
brachytherapy
external beam radiation therapy
plain x-ray
ebrt

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 s 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 followup visits at 1, 3, 6, 9, and 12 months after the completion of radiation therapy. Followup 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, MRI, X-ray) that was done at baseline to evaluate the tumor response.

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 CTV 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 NCI 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 participant s disease status and toxicity outcomes will be documented for a 12-month period at 3-months intervals.

Details
Condition Cervical Cancer, Endometrial Cancer, Esophageal Cancer, Prostate Cancer, Biliary Cancer
Treatment brachytherapy, HDR Brachytherapy
Clinical Study IdentifierNCT00924027
SponsorNational Cancer Institute (NCI)
Last Modified on19 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
ECOG performance status of 0, 1, or 2
Participant must have a primary medical or surgical oncologist in the community or at NCI who is willing to collaborate with the 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)
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 can not undergo resection because of poor lung function or distant lung metastasis
Breast cancer
Infiltrating ductal carcinoma or DCIS, stage T0, T1, and T2 less than or equal to 3.0 cm, N0 and M0
Participants benefiting from 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

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)
Abnormal bleeding times or active anti-coagulation therapy
Pregnant or breast-feeding females are excluded because of the potential mutagenic
platelets less than 100,000 per mm(3)
effects on a developing fetus or newborn
PT/PTT greater than 1.5 the upper normal limit (UNL)
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
Breast cancer
tolerate this therapy or are likely to interfere with the study procedures or results
male participants with breast cancer
Participants who are in the estimation of the PI, deemed unable or unlikely to adhere
to protocol treatment
autoimmune disorders, including SLE, Scleroderma, etc
distant metastases
Prostate cancer
distant metastases
lymph node metastases
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 ABS guidelines
Participants whose malignancy has one or more of the following site-specific criteria
disqualifying them from the study
Participants inappropriate for standard breast conservation therapy (Multicentric
disease, inability to achieve clear margins)
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