Conventional Versus Hypofractionated Radiotherapy in Node Positive Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02690636|
Recruitment Status : Recruiting
First Posted : February 24, 2016
Last Update Posted : June 1, 2016
Breast cancer patients operated with modified radical mastectomy or breast conservative surgery will be randomized for either adjuvant conventional radiotherapy versus hypofractionated radiotherapy for chest wall and axilla or breast and axilla.
The patients will be recruited for one year and will be followed for 5 years by monitoring local recurrence, cosmetic outcomes, health economic perspectives, and arm lymph edema.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: radiotherapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Conventional Versus Hypofractionated Adjuvant Radiotherapy in Node Positive Breast Cancer. Phase III, Open Label, Randomized Trial. Comparing Local Control, Cosmetic Outcome, Arm Lymph Edema and Health Economic Perspectives|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||April 2021|
Active Comparator: Conventional
The patients will receive adjuvant radiotherapy conventionally fractionated 5000 cgy fractionated by 200cgy daily fractions, five fractions per week over 5 weeks with an additional 200cgy daily for five days as boost for patients with breast conservative surgery.
daily fractions, five fractions per week.
The patients will receive adjuvant radiotherapy hypofractionated 266cgy daily fractions, five fractions per week for total 16 fractions and an additional five daily fractions will be added as boost for patients with breast conservative surgery.
daily fractions, five fractions per week.
- Locoregional recurrence [ Time Frame: 5 years ]
Tumor locoregional recurrence is defined as: Any newly suspicious skin change/s or palpable lymph node in the irradiated area (compared to baseline photo and clinical examination of this area) that is/are pathologically proved to be locoregional tumor recurrence.
Suspicious skin change/s and palpable lymph node from baseline photo and baseline clinical examination of the irradiated area will be monitored at 3 months throughout 5 years following the completion of radiotherapy in the two study arms to detect the incidence and time of locoregional recurrence.
- Cosmetic outcomes [ Time Frame: 5 years ]
Aesthetic evaluation of the irradiated breast will be through 3 methods. Patient questionnaire (Subjective evaluation), Harvard score for breast cosmoses (Observer evaluation) and a computer soft ware that calculate the configuration difference between treated and non treated breast. Upon evaluation, each of the three methods will acquire a point ranging from 0 to 3 (poor to excellent cosmetic outcome respectively). The points of the three methods will be added yielding a score ranging from 0 to 9. Score 0-2, 3-4, 5-6 and 7-9 mean poor, fair, good and excellent cosmoses respectively.
The cumulative incidence of changes in breast cosmoses from baseline for every patient will be assessed every year (as described above) through out the 5 years (Time frame of the study) following the completion of radiotherapy in the two study arms. By the end of the five years the aesthetic evaluation for each patient will be through calculating the average of her 5 years score.
- Arm lymph edema. [ Time Frame: 5 years ]To evaluate the cumulative incidence of lymph edema during the 5 years following completion of hypofractionated radiation treatment [ Time Frame: 5 years ] Incidence of lymphedema defined as ≥ 10% increase in arm circumference over baseline circumference compared to the contralateral arm measured every 6 months from the time of initiation of hypofractionated irradiation of breast and regional nodes through 5 years following the completion of radiation therapy in 2 study groups.
- Health economic perspectives [ Time Frame: 5 years ]
The economic perspectives for the public health: (Time frame 5 years). Cost effective analysis of each treatment plan will be evaluated at the end of 5 years through calculation of the cost-effectiveness ratio = Cost of intervention / Health effect produced.
The cost of intervention = the sum of (Cost of medical staff time, drugs and equipment maintenance during the 5 years time frame). (The cost of intervention during the 5 years time frame will be used for calculations).
The health effect produced will be years of local control (Number of years the patient lived without any pathological evidence of local recurrence). (The mean years of local control during the 5 years time frame will be used for calculations).
The treatment program with the less cost effectiveness ratio will be recommended for treating patients.
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): NCT02690636
|Contact: Mahmoud Ellithy, Phd||01000069694 ext firstname.lastname@example.org|
|Cairo, Abbasia, Egypt, 14031|
|Contact: Mahmoud Ellithy, Phd 01000069694 ext 002 email@example.com|
|Sub-Investigator: Heba Abdallah, Specialist|
|Sub-Investigator: Ahmed Nagy, Consultant|
|Sub-Investigator: Lamia Elwakil, Pharmacist|
|Sub-Investigator: Noha Elboghdady, Pharmacist|
|Sub-Investigator: Ahmad Abdel-Hady, Consultant|
|Sub-Investigator: Wael Elsheshtawy, Consultant|
|Sub-Investigator: Rasha Haggag, Consultat|
|Sub-Investigator: Mohamed A. Alm El-Din, Consultant|
|Sub-Investigator: Mostafa Elnaggar, Consultant|
|Sub-Investigator: Marwa I. Abdelgawad, Consultant|
|Sub-Investigator: Abdelmoneim Elsayed, Consultant|
|Principal Investigator:||Mahmoud Ellithy, Phd||Ain Shams University|