MGH IRB #03-010A Phase 2 study evaluating external beam radiation and transperineal implantation in combination with chemotherapy and androgen suppression therapy in patients with non-metastatic prostate cancer.
This study is for patients with localized prostate cancer to receive external beam radiation, transperineal implant, androgen suppression and chemotherapy.
To be eligible patients must have:
A confirmed diagnosis of cancer of the prostate.
A gleason grade of 7 or greater.
Prostate Specific Antigen of 10 or greater.
Or any gleason grade with a prostate specific antigen greater than 20.
Lymph nodes must be negative for metastasis.
Patient must have not had any prior chemotherapy or radiation therapy.
If hormone deprivation has been started it must have been less than 2 months ago.
Patients must have no other serious medical or psychiatric problems.
If patient meets all the above criteria then further lab work would be evaluated to determine if the patient qualifies for the study.
MGH IRB #03-012This study is to promote the use of chemotherapy and hormone suppression prior to radical prostatectomy. The desired response is to decrease the number of recurrences in patients with high risk prostate cancer.
To be eligible patients must have:
PSA greater than 10 with Gleason Grade of 7 or greater.
Or PSA 20 or above.
Or Gleason grade greater than 8.
Patient must have had no prior treatment with anthracyclines or taxanes.
Patients must have no other serious medical or psychiatric illnesses.
Patients must have no other history of cancer.
If patient meets all the above criteria then further lab work would be evaluated to determine if the patient qualifies for the study.
RTOG 0413 (NSABP PROTOCOL B-39)
A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer.
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Investigator: Chad Deyoung, M.D.
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Summary: This Phase III randomized trial will evaluate the effectiveness of partial breast irradiation (PBI) compared to whole breast irradiation (WBI) in providing equivalent local tumor control in the breast following lumpectomy for early stage breast cancer. The study will compare the overall survival, recurrence-free survival, and distant disease-free survival between women receiving PBI and WBI. It will also look at quality of life (QOL) issues related to cosmesis, fatigue, treatment-related symptoms, and perceived convenience of care.
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Disease site: Breast
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Disease stage: 0, I and II
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Condition: Breast cancer
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Intervention: Radiation Therapy
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Phase: III
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Study number: RTOG 0413 (NSABP PROTOCOL B-39)
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Eligibility*
(inclusion criteria) Women who satisfy all of the following conditions are the only patients who will be eligible for this study.
- The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines.
- Patients must be 18 years old or older.
- The patient should have a life expectancy of at least ten years, excluding her diagnosis of breast cancer. (Comorbid conditions should be taken into consideration, but not the diagnosis of breast cancer.)
- The patient must have stage 0,1, or II breast cancer. If stage II, the tumor size must be 3 cm or less.
- On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast.
- Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (DCIS and invasive). Re-excision of surgical margins is permitted.
- Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 3 cm or less. (Patients with microscopic multifocality are eligible as long as total pathologic tumor size is 3 cm or less.)
- Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if sentinel node is negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes (if sentinel node is positive), or axillary dissection alone (with a minimum of 6 axillary nodes). (Axillary staging is not required for patients with DCIS.)
- The patient must be randomized within 42 days following the last surgery for breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure).
- Patients must have an estrogen receptor (ER) analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then progesterone receptor (PgR) analysis must be performed. If ER analysis is positive, PgR analysis is desired but not mandatory. ("Marginal" or "borderline" results [i.e., those not definitively negative] will be considered positive regardless of the methodology used.)
- The target lumpectomy cavity must be clearly delineated and the target lumpectomy cavity/whole breast reference volume must be 30% or less based on the postoperative/pre-randomization CT scan.
- Patients are eligible if, based on the postoperative/pre-randomization CT scan, PBI is judged to be technically deliverable by a technique for which the radiation oncology facility has been credentialed.
- At the time of randomization, patients must have had an H&P within 4 months and a bilateral mammogram within 6 months.
- Patients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
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Eligibility*
(exclusion criteria) Men are not eligible for this study. Women with one or more of the following conditions also are ineligible for this study.
- T2 (over 3.0 cm), T3, stage III, or stage IV breast cancer (see Appendix A for TNM nomenclature and staging).
- More than 3 histologically positive axillary nodes.
- Axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension.
- One or more positive non-axillary sentinel node(s). (Note that intramammary nodes are staged as axillary nodes.)
- Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
- Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
- Non-epithelial breast malignancies such as sarcoma or lymphoma.
- Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters.
- Paget's disease of the nipple.
- Synchronous bilateral invasive or non-invasive breast cancer.
- History of invasive breast cancer or DCIS. (Patients with a history of LCIS treated by surgery alone are eligible.)
- Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re-excision, the patient is eligible.)
- Clear delineation of the extent of the target lumpectomy cavity not possible.
- Treatment plan that includes regional nodal irradiation.
- Any treatment with radiation therapy, chemotherapy, biotherapy, and/or hormonal therapy administered for the currently diagnosed breast cancer prior to randomization. The only exception is hormonal therapy, which may have been given for no more than a total of 28 days anytime after diagnosis and before randomization. For patients who will be receiving chemotherapy, hormonal therapy must stop at or before randomization and resume following completion of chemotherapy. For patients who will not be receiving chemotherapy, hormonal therapy may continue. (Refer to Section 15.2 for information on hormonal therapy.)
- Current therapy with any hormonal agents such as raloxifene (Evista®), tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention. (Patients are eligible only if these medications are discontinued prior to randomization.)
- Breast implants. (Patients who have had implants removed are eligible.)
- Prior breast or thoracic RT for any condition.
- Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
- Pregnancy or lactation at the time of proposed randomization. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.
- Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
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Contact Person: Luther Ampey, III, MD, 301-260-3700
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* Note: This study may include eligibility criteria that are not listed here. For more information about the study or to find out if you are eligible, call 1-800-492-5538.