- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01016574
Evaluating the Adequacy of Giro-Couch to Support Prone Breast Boost Irradiation Using IMRT Technique With IGRT. (IN902)
August 2, 2011 updated by: Azimuth Therapy Ltd.
Evaluating the Adequacy of Giro-Couch to Support Prone Breast Boost Irradiation Using Intensity Modulated Radiation Therapy(IMRT)Technique With Image-guided Radiation Therapy(IGRT).
The purpose of this study is to evaluate the Giro-couch, an innovative patient support device for the application of prone RT for treatment of breast cancer.
This study will assess the feasibility of a new positioning approach to facilitate the delivery of external beam, delivered to the lumpectomy cavity, (the boost dose, partial breast therapy).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Treatments are applied with the subject in the supine position, in ~50 Gy per treatment (~2GY per fraction), over a period of five to six weeks.
Energy in use is usually 6-15MV photons.
Following the whole breast irradiation, a boost dose is given to the lumpectomy cavity, in order to further reduce the local recurrences in the immediate vicinity of the treated breast.
The boost dose is usually applied with electrons, 6-18MEV.
Sixteen Gy is the usual dose, 2 Gy/Fx, for 8 fractions.
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Merav Ben-David, M. D.
- Phone Number: +972 - 3-5302542
- Email: Merav.Ben-David@sheba.health.gov.il
Study Locations
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-
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Tel Hashomer, Israel, 52621
- The Chaim Sheba Medical Center
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Contact:
- Merav Ben-David, M. D.
- Phone Number: +972 -3-5302542
- Email: Merav.Ben-David@sheba.health.gov.il
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Principal Investigator:
- Merav Ben-David, M. D.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 to federal and institutional guidelines.
- Patients must be ≥ 40 years old.
- The patient must have stage I or II breast cancer. If stage II, the tumor size must be 3 cm or less.
- Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be at least 2mm. Re-excision of surgical margins is permitted.
- Gross disease must be unifocal.
- The target lumpectomy cavity must be clearly delineated and the target lumpectomy cavity/whole breast reference volume must be ≤ 30% based on the treatment planning CT scan.
- The lumpectomy cavity must be delineated with surgical clips by the surgeon.
- Patients are eligible if, based on the postoperative/ simulation CT scan, prone boost RT is judged to be technically deliverable by a prone breast IMRT-IGRT technique.
- 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.
Exclusion Criteria:
- Men are not eligible for this study. Women with one or more of the following conditions also are ineligible for this study.
- T0, T2 (> 3.0 cm), T3, stage III, or stage IV breast cancer (see Appendix A for TNM nomenclature and staging).
- 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.
- 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.
- Breast implants.
- Prior breast or thoracic RT for any condition
- Collagen vascular disease, specifically dermatomyositis, 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: women with stage I or II breast cancer
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Boost irradiation is applied to the ipsilateral breast in eight fractions of 2Gy/Fx
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ease of use and Comfort scale 1-5
Time Frame: Treatment Day 1 and Treatment Day 8
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The endpoints will be assessed at the conclusion of the subject's first treatment on Treatment Day 1, and at the conclusion of the subject's treatment on Treatment Day 8. Thus the time frame for the Primary Outcome Measure for each subject is 1-8 days.
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Treatment Day 1 and Treatment Day 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dosimetric evaluation
Time Frame: Treatment Day 1, Treatment Day 2, Treatment Day 3, Treatment Day 4, Treatment Day 5, Treatment Day 6, Treatment Day 7, Treatment Day 8
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A Dosimetric evaluation will be performed for each subject, each and every day of subjects's treatment.
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Treatment Day 1, Treatment Day 2, Treatment Day 3, Treatment Day 4, Treatment Day 5, Treatment Day 6, Treatment Day 7, Treatment Day 8
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Localization time
Time Frame: Treatment Day 1, Treatment Day 2, Treatment Day 3, Treatment Day 4, Treatment Day 5, Treatment Day 6, Treatment Day 7, Treatment Day 8
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The time required for target localization will be performed each and every day of each subject's treatment.
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Treatment Day 1, Treatment Day 2, Treatment Day 3, Treatment Day 4, Treatment Day 5, Treatment Day 6, Treatment Day 7, Treatment Day 8
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Treatment time
Time Frame: Treatment Day 1, Treatment Day 2, Treatment Day 3, Treatment Day 4, Treatment Day 5, Treatment Day 6, Treatment Day 7, Treatment Day 8
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The time required to apply the prescribed treatment (beam on to beam off).
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Treatment Day 1, Treatment Day 2, Treatment Day 3, Treatment Day 4, Treatment Day 5, Treatment Day 6, Treatment Day 7, Treatment Day 8
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (ANTICIPATED)
September 1, 2012
Study Completion (ANTICIPATED)
December 1, 2012
Study Registration Dates
First Submitted
November 18, 2009
First Submitted That Met QC Criteria
November 18, 2009
First Posted (ESTIMATE)
November 19, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
August 3, 2011
Last Update Submitted That Met QC Criteria
August 2, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- 7326-09-SMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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