Clinical Trials /

A Study of Patients Receiving High-Dose Rate Brachytherapy

NCT00924027

Description:

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.

Related Conditions:
  • Breast Invasive Ductal Carcinoma
  • Cervical Carcinoma
  • Ductal Carcinoma In Situ
  • Endometrial Carcinoma
  • Lung Carcinoma
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Patients Receiving High-Dose Rate Brachytherapy
  • Official Title: A Pilot Study of High Dose Rate Brachytherapy in The Radiation Oncology Branch

Clinical Trial IDs

  • ORG STUDY ID: 090100
  • SECONDARY ID: 09-C-0100
  • NCT ID: NCT00924027

Conditions

  • Cervical Cancer
  • Endometrial Cancer
  • Esophageal Cancer
  • Prostate Cancer
  • Biliary Cancer

Purpose

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.

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 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.
    

Trial Arms

NameTypeDescriptionInterventions
1/Radiation TherapyExperimental

    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. ECOG performance status of 0, 1, or 2.
    
                   4. 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.
    
                   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.
    
                   6. 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:
    
              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)
    
                   -  PT/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 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 SLE, Scleroderma, etc
    
              -  distant metastases;
    
                 2. Prostate cancer:
    
              -  distant metastases
    
              -  lymph node metastases
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:To determine the quality of high dose rate brachytherapy implants performed in the radiation oncology branch.
    Time Frame:Completion of treatment
    Safety Issue:
    Description: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.

    Secondary Outcome Measures

    Measure:To evaluate local control and late toxicity rates following brachytherapy at NCI ROB.
    Time Frame:Completion of study
    Safety Issue:
    Description:To evaluate local control and late toxicity rates following brachytherapy at NCI ROB.
    Measure:To increase the flow of oncology patients requiring brachytherapy to the NCI ROB. As these patients lend themselves to special study and have unique educational value for the purpose of educating nurses, medical students, residents, physicist...
    Time Frame:Completion of study
    Safety Issue:
    Description:To increase the flow of oncology patients requiring brachytherapy to the NCI ROB. As these patients lend themselves to special study and have unique educational value for the purpose of educating nurses, medical students, residents, physicists, clinical fellows, and physicians

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:National Cancer Institute (NCI)

    Trial Keywords

    • Radiation
    • Cancer
    • HDR
    • Brachytherapy
    • Training

    Last Updated

    January 14, 2021