Trial to Compare Radiation Fibrosis With Five Versus Three Fractions
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|ClinicalTrials.gov Identifier: NCT02755896|
Recruitment Status : Recruiting
First Posted : April 29, 2016
Last Update Posted : August 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasm of Breast Stage I||Radiation: Arm 1 600 cGY x 5 fractions Radiation: Arm 2 800 cGY x 3 fractions||Not Applicable|
Partial breast irradiation (PBI) is becoming a new paradigm for breast cancer radiation. No type I or II evidence is currently available to demonstrate equivalence to standard whole breast radiotherapy, and a prospective randomized trial jointly sponsored by NSABP and Radiation therapy Oncology Group (RTOG) (NSABP B-39 and RTOG 0413) has completed accruing patients, comparing whole breast radiotherapy to PBI, either by brachytherapy or external beam techniques (EB): results of this trial are pending. Until results of this or similar trials are available, PBI remains a research domain, and it should be offered to patients only in the context of a clinical experimental protocol. Despite the fact that less extensive experience than that of brachytherapy is available, PBI delivery through an external-beam has many advantages. First of all, it is likely to be more acceptable to the patient since it is non-invasive and it does not require a surgical procedure or anesthesia. Moreover, since it is delivered after surgery, the pathological analysis of the segmental mastectomy specimen is available to inform the selection of the best candidates. In addition, EB-PBI is likely to become more widely reproducible, since it does not rely on the experience and skills of the radiation oncologist performing the brachytherapy implant. Besides, once the technique is established, it can be widely applied at any facility provided with a linear accelerator, without the risk presented by some brachytherapy approaches that cannot be completed because of the unfavorable interplay of patient's anatomy with the technical limitations of the applicator. Finally, in terms of health care economics, an external beam approach spares the costs of an extra surgical procedure and several days as inpatient (in the case of Low dose Rate (LDR) brachytherapy).
A prone approach for partial breast radiation has been tested at NYU in a clinical trial sponsored by an IDEA grant of the Department of Defense (NYU 00-23). Results of the first 47 patient accrued originally demonstrated feasibility. Eligibility to this study was limited to post-menopausal women with non-palpable, mammographically detected tumors. In addition, the protocol required patients to have first refused to undergo standard six-week radiotherapy. Five fractions of 6 Gy were delivered to the Planning Target Volume (PTV) over ten days (Monday-Wednesday-Friday, Monday-Wednesday). The dose and fractionation was based on radiobiological modeling, aimed at determining a dose to deliver in five fractions that would achieve equivalence to the tumor control estimates of 50 Gy in 25 fractions, while maintaining a risk of fibrosis at the tumor bed comparable to that of a standard regimen of 60 Gy in 30 fractions. An α/β = 4 for tumor control was used, and its validity has been recently confirmed by the results of a prospective randomized trial comparing accelerated to standard whole breast radiotherapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||284 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prone Partial Breast Irradiation (PBI): Prospective Randomized Controlled Non-inferiority Trial to Compare Radiation Fibrosis With Five Versus Three Fractions|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2022|
Arm 1 - 600 cGY x 5 fractions
Patients will receive 600 cGY x 5 fractions of radiation therapy over 5 consecutive days.
Radiation: Arm 1 600 cGY x 5 fractions
Patients who are randomized to Arm 1 will receive either 600 cGY x 5 fractions over 5 consecutive days
Arm 2 - 800 cGY x 3 fractions
Patients will receive 800 cGY x 3 fractions of radiation therapy every other day for 3 days.
Radiation: Arm 2 800 cGY x 3 fractions
Patients who are randomized to Arm 2 will receive 800 cGY x 3 fractions given every other day
- Local recurrence rate at 5 years (284 total patients in both arms) [ Time Frame: 48 - 60 months ]Investigators will measure non-inferiority to the current 1% local recurrence rate at 5 years
- Fibrosis rate at 5 years [ Time Frame: 60 months ]Investigators will measure the non-inferiority to the 5 year fibrosis rate of 24-36%
- Isolated local/regional recurrences [ Time Frame: 48-60 months ]
At the time of local recurrence, patients will undergo disease assessment and will be further grouped as:
Isolated local/regional recurrence Concomitant local/regional and distant recurrence
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): NCT02755896
|Contact: Sharanya Chandrasekhar, M.S.||email@example.com|
|Contact: Pragya Yadav, Ph.D.||firstname.lastname@example.org|
|United States, New York|
|Weill Cornell Medical College||Recruiting|
|New York, New York, United States, 10065|
|Contact: Silvia Formenti, M.D 212-746-7277 email@example.com|
|Contact: Sharanya Chandrasekhar, M.S. 212-746-7277 firstname.lastname@example.org|
|Principal Investigator:||Silvia C Formenti, M.D.||Weill Medical College of Cornell University|