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Evaluating the Adequacy of Giro-Couch to Support Prone Breast Boost Irradiation Using IMRT Technique With IGRT. (IN902)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by Azimuth Therapy Ltd..
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01016574
First Posted: November 19, 2009
Last Update Posted: August 3, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Azimuth Therapy Ltd.
  Purpose
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).

Condition Intervention Phase
Breast Cancer Device: Support Device for Prone radiation therapy (Giro-Couch) Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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).

Resource links provided by NLM:


Further study details as provided by Azimuth Therapy Ltd.:

Primary Outcome Measures:
  • Ease of use and Comfort scale 1-5 [ Time Frame: Treatment Day 1 and Treatment Day 8 ]
    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.


Secondary Outcome Measures:
  • 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 ]
    A Dosimetric evaluation will be performed for each subject, each and every day of subjects's treatment.

  • 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 ]
    The time required for target localization will be performed each and every day of each subject's treatment.

  • 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 ]
    The time required to apply the prescribed treatment (beam on to beam off).


Estimated Enrollment: 15
Study Start Date: December 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
women with stage I or II breast cancer Device: Support Device for Prone radiation therapy (Giro-Couch)
Boost irradiation is applied to the ipsilateral breast in eight fractions of 2Gy/Fx

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.
  Eligibility

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01016574


Contacts
Contact: Merav Ben-David, M. D. +972 - 3-5302542 Merav.Ben-David@sheba.health.gov.il

Locations
Israel
The Chaim Sheba Medical Center Not yet recruiting
Tel Hashomer, Israel, 52621
Contact: Merav Ben-David, M. D.    +972 -3-5302542    Merav.Ben-David@sheba.health.gov.il   
Principal Investigator: Merav Ben-David, M. D.         
Sponsors and Collaborators
Azimuth Therapy Ltd.
  More Information

Responsible Party: Merav Ben-David, M. D., Institute of Oncology , The Chaim Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01016574     History of Changes
Other Study ID Numbers: 7326-09-SMC
First Submitted: November 18, 2009
First Posted: November 19, 2009
Last Update Posted: August 3, 2011
Last Verified: August 2011