A Study of Patients Receiving High-Dose Rate Brachytherapy

• 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 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 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
• lymph node metastases