A PHASE I TRIAL OF STEREOTACTIC RADIOSURGERY FOR PATIENTS WITH TUMORS OF THE KIDNEY
UTSW IRB# 122004-002
Principal Investigator: L. Chinsoo Cho, MD
Coordinator: Carolyn Zwartjes
Contact Number: (214) 648-5536

OBJECTIVES:Stereotactic Radiosurgery is the use of multiple x-ray beams that are focused directly at tumors while protecting the healthy tissue from radiation exposure as much as possible.  The purpose of this research is to determine the maximum dose of this type of radiotherapy that a patient can safely have when the cancer is located in the kidney. In addition, we want to learn about the side effects of this treatment when given to the kidney.

The effects of stereotactic radiotherapy on kidney tumors will be checked by CT scans and/or MRI scan. These scans are all ways of measuring whether the kidney tumor has grown, stayed the same, or reduced in size. This research is being done because new ways of using radiation treatment have been developed and are now available.  This new treatment better allows us to send radiation treatment to a small tumor area and spare normal tissue close to the tumor. The stereotactic method of treating kidney tumors may or may not be shown to be better than the treatment that is currently available.
Number of Participants:  39 (UTSW study only)

KEY INCLUSION CRITERIA:

• Histologically proven primary renal cancer.
• All eligible patients must have tumor that is visualized on either CT scans and/or MRI of the abdomen.
• The cumulative total dose to the half or more of the targeted normal kidney must be less than or equal to 10 Gy.
• There must be no other antineoplastic treatment given concomitantly with radiotherapy.
• Patients must agree to percutaneous biopsy of the kidney tumor and placement of three to five fiducials.
• Patients must be past their 18th birthday at the time of registration.
• The patient's Karnofsky performance status must be > 60%.  Patient must be able to care for most personal needs and require only occasional assistance.
• Patients must have life expectancy > 3months.
• All patients must be willing and capable to provide informed consent to participate in the protocol.
• Patients must have following laboratory parameters:

KEY EXCLUSION CRITERIA:

• Patient unable to cooperate with requirements of the protocol.
• Patients with prior radiation to the abdomen.
• Prior history of diagnosed inflammatory bowel disease, such as ulcerative colitis or Crohn’s.
• Patients with active peptic ulcer disease
• Patients with hepato-renal syndrome.
• Pregnant or lactating women are ineligible. Women/men of reproductive potential may not participate unless they agree to use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills.
• Patients with malignant ascites.

SCHEMA

Eligible Patient (Unilateral Kidney Tumor <3 cm)
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Stereotactic Radiosurgery

Total dose is given in three fractions of stereotactic radiosurgery. Entire treatment will be delivered within 12 days.
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Assess toxicity and response to treatment by CT scans or MRI

OBJECTIVES: One of the standard treatment options for localized prostate cancer is external beam radiation therapy.  Modern radiation therapy planning methods with 3-dimensional therapy or Intensity Modulated Radiation Therapy (IMRT) allow safer delivery of higher than conventional doses of radiation. Both three-dimensional radiation therapy and IMRT allow the radiation beam to treat an area that is shaped like the prostate gland and also to penetrate as deeply as the prostate gland is located.  By treating this way, the dose of radiation to the healthy areas near the prostate gland is minimized, and the dose to the prostate gland is maximized.  This research is being done because doses higher than the standard dose of radiation therapy may better control cancer without increased toxicity. 

The purpose of this research is to compare the effects, both good and bad, on patients and their cancer.  This study will help to determine whether a higher dose of radiation with more treatments (44 treatments) will improve overall survival as compared to the standard radiation treatments (39 treatments). The study will also determine the incidence of immediate and long-term side effects of these treatments as well as study biologic factors that may help to predict and treat prostate cancer.  In addition, the study will compare quality of life, including sexual function, in the two treatment groups. This research is being done because it is not known whether a higher dose of radiation over a longer period of time will improve long-term survival.
Number of Participants:  National:  1520 -- Local: 15-20

KEY INCLUSION CRITERIA:

• Histologically confirmed prostate adenocarcinoma within 180 days of randomization.
• Zubrod Performance Scale 0-1.
• Prostatic biopsy tumor grading by the Gleason Score Classification.
• One of the following combinations of factors:
      • Clinical stage T1b-T2b, Gleason score 2-6, and prostate-specific antigen > 10 but < 20
      • Clinical stage T1b-T2b, Gleason score 7 and prostate-specific antigen < 15
• Pretreatment evaluations must be completed as specified in Section 4.1 (9/18/03).
• Patients must sign a study-specific informed consent form prior to randomization.

KEY EXCLUSION CRITERIA:

• Evidence of distant metastases.
• Regional lymph node involvement.
• Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer.
• Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy.
• Previous hormonal therapy, such as LHRH agonists (e.g. goserilin, leuprolide), anti-androgens (e.g. flutamide, bicalutamide), estrogens (e.g. DES), or surgical castration (orchiectomy).
• Use of finasteride (Proscar) or the phytoestrogen preparation “PC-SPES” within 3 months prior to registration.
• Previous or concurrent cytotoxic chemotherapy for this cancer.
• Previous or concurrent invasive cancers, other than localized basal cell or squamous cell skin carcinoma, unless continually disease free for at least 5 years.
• Major medical or psychiatric illness that, in the investigator's opinion, would prevent completion of treatment and interfere with follow up.

                                                          SCHEMA (9/18/03)

S     Gleason Score/PSA                    R          Arm 1 (minimum PTV prescription)      
T       1. Gleason 2-6                            A          3D-CRT or IMRT: 70.2 Gy in 39 fractions
R        and PSA > 10 but < 20              N
A      2. Gleason 7                                D
T        and PSA < 15                             O         Arm 2 (minimum PTV prescription)
I                                                           M          3D-CRT or IMRT: 79.2 Gy in 44 fractions
F      Radiation Modality                      I
Y      1.  3D-CRT                                    Z
         2.  IMRT                                        E

Treatment is prescribed as a minimum to the planning target volume (PTV) to be delivered at a rate of 1.8 Gy/daily fraction. The PTV includes with margin a clinical target volume that encompasses the prostate and proximal seminal vesicles (see section 6.0). A “cone-down” after 55.8 Gy to a planning target volume encompassing the prostate only will be optional for forward planned 3D-CRT. (9/18/03)