Phase 2 N=43 Treatment

A Study of Patients Receiving High-Dose Rate Brachytherapy

Cervical Cancer · Endometrial Cancer · Esophageal Cancer · Prostate Cancer · Biliary Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00924027 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2024

Primary outcome: Primary: Number of Participants Who Had Adequate High-Quality Brachytherapy Implants Reported Per Strata (Four Body Sites) and Combined Overall — 27; 0; 0; 14 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: High Dose Radiation (HDR) Brachytherapy (Radiation); MRI (Diagnostic_test); CT (Diagnostic_test); PET Scan (Diagnostic_test)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Cancer Institute (NCI)
Primary completion: May 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Had Adequate High-Quality Brachytherapy Implants Reported Per Strata (Four Body Sites) and Combined Overall	27; 0; 0; 14; 41	—
SECONDARY Number of Prostate Participants With Local Control	0; 14; 0	—
SECONDARY Number of Participants With Local Control Reported Per Strata (Body Sites) and Combined Overall	25; 0; 0; 25; 0; 0	—
SECONDARY Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall	0; 0; 0; 8; 17; 25	—
SECONDARY Number of Participants Accrued Who Received Brachytherapy Each Year	3; 0; 3; 2; 0; 2	—

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.

Eligibility Criteria

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.
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):

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

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

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Data sourced from ClinicalTrials.gov (NCT00924027). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.