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A Natural History Study of Patients Receiving High Dose Rate Brachytherapy


N/A
18 Years
90 Years
Open (Enrolling)
Both
Cervical Cancer, Endometrial Cancer, Esophageal Cancer, Prostate Cancer, Biliary Cancer

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Trial Information

A Natural History Study of Patients Receiving High Dose Rate Brachytherapy


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Principal Investigator

Aradhana Kaushal, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

090100

NCT ID:

NCT00924027

Start Date:

March 2009

Completion Date:

November 2013

Related Keywords:

  • Cervical Cancer
  • Endometrial Cancer
  • Esophageal Cancer
  • Prostate Cancer
  • Biliary Cancer
  • Radiation
  • Cancer
  • HDR
  • Brachytherapy
  • Training
  • Endometrial Neoplasms
  • Uterine Cervical Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Prostatic Neoplasms
  • Adenoma
  • Biliary Tract Neoplasms

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892