Protocol Number: 09-C-0100

Title:

A Natural History Study of Patients Receiving High Dose Rate Brachytherapy

Number:

09-C-0100

Summary:

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.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility 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 ULN

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

Special Instructions:

Currently Not Provided

Keywords:

Radiation

Cancer

HDR

Brachytherapy

Training

Recruitment Keyword(s):

None

Condition(s):

Cervical Cancer

Endometrial Cancer

Esophageal Cancer

Prostate Cancer

Biliary Cancer

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

Procedure/Surgery: Brachytherapy

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

Creutzberg CL, van Putten WL, Koper PC, Lybeert ML, Jobsen JJ, W‡rl‡m-Rodenhuis CC, De Winter KA, Lutgens LC, van den Bergh AC, van de Steen-Banasik E, Beerman H, van Lent M. Surgery and postoperative radiotherapy versus surgery alone for patients with stage-1 endometrial carcinoma: multicentre randomised trial. PORTEC Study Group. Post Operative Radiation Therapy in Endometrial Carcinoma. Lancet. 2000 Apr 22;355(9213):1404-11.

Kocak Z, Ozkan H, Adli M, Garipagaoglu M, Kurtman C, Cakmak A. Intraluminal brachytherapy with metallic stenting in the palliative treatment of malignant obstruction of the bile duct. Radiat Med. 2005 May;23(3):200-7.

Perez CA, Grigsby PW, Castro-Vita H, Lockett MA. Carcinoma of the uterine cervix. I. Impact of prolongation of overall treatment time and timing of brachytherapy on outcome of radiation therapy. Int J Radiat Oncol Biol Phys. 1995 Jul 30;32(5):1275-88.

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