A Natural History Study of Patients Receiving High Dose Rate Brachytherapy

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