A Natural History Study of Patients Receiving High-Dose Rate Brachytherapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00924027
First received: June 17, 2009
Last updated: March 14, 2014
Last verified: January 2014
  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.

Condition Intervention
Cervical Cancer
Endometrial Cancer
Esophageal Cancer
Prostate Cancer
Biliary Cancer
Procedure: Brachytherapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Natural History Study of Patients Receiving High Dose Rate Brachytherapy

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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 prescribed dose.

Secondary Outcome Measures:
  • To evaluate local control and late toxicity rates following brachytherapy at NCI ROB. Increase the flow of oncology patients requiring brachytherapy to the NCI ROB, as these patients lend themselves to special study and have unique educational v...

Estimated Enrollment: 112
Study Start Date: March 2009
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Brachytherapy
    N/A
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 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.

ELIGIBILITY:

-Patients with cancer who could potentially benefit from the use of high dose rate brachytherapy as a component of their treatment.

DESIGN:

  • 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. This treatment will be administered in accordance with standard radiation oncology practice and per the ABS (American Brachytherapy Society) guidelines.
  • The natural history of the patient s disease status and toxicity outcomes will be documented for a 12-month period at 3-months intervals.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. 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.
    5. 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.
    6. Site-specific inclusion criteria (any one or more of the following):

Gynecologic Cancers:

Endometrial cancer

  • Patients 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)
  • 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 either in a palliative or curative setting (definitive or post-operative setting).

Lung cancer

  • Patients with an endobronchial component causing symptoms
  • Patients 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,
  • Patients benefiting from HDR as either as a boost or accelerated partial breast irradiation regimen.

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

EXCLUSION CRITERIA:

  1. Cognitively impaired patients who cannot give informed consent and do not have a legal guardian.
  2. Patients currently receiving concurrent investigational chemotherapeutic agents.
  3. 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)
  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 patient s ability to tolerate this therapy or are likely to interfere with the study procedures or results.
  6. Patients 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 patient 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. Patients whose malignancy has one or more of the following site-specific criteria disqualifying them from the study:

1. Breast cancer:

  • Patients inappropriate for standard breast conservation therapy (Multicentric disease, inability to achieve clear margins);
  • male patients with breast cancer
  • autoimmune disorders, including SLE, Scleroderma, etc
  • distant metastases;

    2. Prostate cancer:

  • distant metastases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924027

Contacts
Contact: Sharon L Smith, R.N. (301) 451-8905 smiths@mail.nih.gov
Contact: Aradhana Kaushal, M.D. (301) 496-5457 kaushala@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    (888) NCI-1937      
Sponsors and Collaborators
Investigators
Principal Investigator: Aradhana Kaushal, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00924027     History of Changes
Other Study ID Numbers: 090100, 09-C-0100
Study First Received: June 17, 2009
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Radiation
Cancer
HDR
Brachytherapy
Training

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Cervical Neoplasms
Esophageal Neoplasms
Prostatic Neoplasms
Biliary Tract Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Uterine Cervical 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
Biliary Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014