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Solid Tumor

A Natural History Study of Patients Receiving High Dose Rate Brachytherapy

NCI-09-C-0100, NCT00924027

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Investigator(s):

Aradhana Kaushal, M.D.
Principal Investigator
Phone: 301-496-5457
kaushala@mail.nih.gov

Referral Contact(s):

Sharon L. Smith, R.N., M.S., O.C.N., C.C.R.P.
Research Nurse
Phone: 301-496-5457
Fax: 301-480-2347
smiths@mail.nih.gov

 

Key Eligibility Criteria:

  • Pathologically confirmed malignancy for which high dose rate brachytherapy is appropriate as a component of the patient’s therapeutic regimen
  • Site-specific inclusion criteria (any one or more of the following):
    • Endometrial cancer
      • Patients at a higher risk of recurrence (because of grade, myometrial invasion, lymphatic vascular space invasion, tumor size, lymph node status, tumor extension, presence or absence of surgical staging)
      • Patients who have suffered a recurrence at the vaginal cuff
      • Patients who are unable to undergo surgery and must have treatment for an inoperable primary endometrial cancer
    • Cervical cancer
      • Patients who are unable to undergo surgery and must have treatment for an inoperable primary cervical cancer
      • Patients with locally advanced cervical cancer in whom brachytherapy will be integrated as a boost to external beam radiation in either a palliative or curative setting (definitive or post-operative setting)
    • Lung cancer
      • Patients with an endobronchial component causing symptoms
      • Patients who cannot undergo resection because of poor lung function or distant lung metastasis
    • Breast cancer
      • Female
      • Disease not appropriate for standard breast conservation therapy (e.g., multicentric disease, inability to achieve clear margins)
      • Infiltrating ductal carcinoma or DCIS, stage T0, T1, and T2 ≤ 3 cm, N0 and M0
      • Patients benefiting from HDR as either a boost or an accelerated partial breast irradiation regimen
      • No distant metastasis
      • No autoimmune disorders, including SLE and scleroderma
    • Prostate cancer
      • Patients with high-risk disease in whom brachytherapy will be integrated as a boost to external beam radiation; patients with stage T1b–T3b prostate cancer
      • No distant metastasis
  • ≥ 18 years of age
  • ECOG ≤ 2
  • Patient 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 patient
  • No abnormal bleeding times or active anti-coagulation therapy
  • Not pregnant or nursing, patients 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
  • No tumor/anatomical factors that may prevent brachytherapy apparatus from being properly and safely inserted and positioned or that may prevent radiation therapy from being administered per ABS guidelines
  • No clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic, or other organ dysfunction) that in the judgment of the principal or associate investigator would compromise the patient’s ability to tolerate this therapy or is likely to interfere with the study procedures or results
  • No concurrent investigational chemotherapeutic agents
  • No cognitively impaired patients who cannot give informed consent and do not have a legal guardian
  • No patients 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)

Study Outline:

  • Patients 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
  • Patients will be treated with high-dose brachytherapy appropriately sequenced with other modalities in their treatment regimen; treatment will be administered in accordance with standard radiation oncology practice and per the American Brachytherapy Society guidelines

Additional Information:

  • This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
  • There is no charge for medical care received at NIH Clinical Center.
  • FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, and study outline.
  • PDQ (Physicians Data Query) - provides additional details about this study for health care providers.


Reviewed: 9/11/12
Updated: 2/24/12

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