Protocol Number: 09-C-0100

Title:

A Natural History Study of Patients Receiving High Dose Rate Brachytherapy

Number:

09-C-0100

Summary:

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 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 of 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.

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 a palliative or curative setting (definitive or post-operative setting).

Lung cancer

- Patients with a 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; (6)

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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