Breast CancerPhase 3NCT02690636
Conventional Versus Hypofractionated Radiotherapy in Node Positive Breast Cancer
A Phase 3 study testing radiotherapy in people with Breast Cancer, run by Ain Shams University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to Apr 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG. (Eastern Cooperative Oncology Group): 0-2
- Histologic documentation of invasive duct or lobular adenocarcinoma of the breast
- If neoadjuvant chemotherapy was NOT administered: pathologic T1-3, N1-2 following definitive surgery
- If neoadjuvant chemotherapy was administered, pathology from the definitive surgery must confirm pathologic T1-3, N1-2 disease and also meet one of the following criteria:
- Clinical T1-3, N1-2 or Pathologic confirmation of axillary nodal involvement at presentation (ie, before neoadjuvant therapy) based on any of the following: Positive fine-needle aspiration (FNA), Positive core needle biopsy.
- Complete resection of known breast disease by one of the following surgeries Lumpectomy with axillary lymph node dissection with no more than 12 resected lymph nodes.
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- Mastectomy and axillary lymph node dissection with no more than 12 resected lymph nodes.
- 5- ER(estrogen-receptor), PR (progesterone-receptor), and HER2(human epidermal growth factor receptor 2) testing performed on the primary breast tumor; when applicable, testing must have been performed before receiving neoadjuvant chemotherapy.
- 6-Margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the pathologist.
- 7-The surgical wound should be completely healed without any signs of infection.
- 8-Interval between the last surgery for breast cancer or the completion of adjuvant chemotherapy and study enrollment must be ≤ 56 days (ie, a maximum of 8 weeks).
- 9-If adjuvant chemotherapy is received there should be at least 10 days gap between the last day of chemotherapy and the enrollment in the study to avoid skin toxicity.
- 10-Women of child-bearing potential must agree to use a medically accepted form of pregnancy prevention for the duration of study treatment 11-Ability to understand and willingness to sign the consent form written in Arabic
Who cannot join
- Patients with surgical margins less than or equal to 2mm.
- Patients with axillary dissection of more than 12 lymph nodes due to high incidence of arm lymphedema.
- Women with Huge pendulous breast.
- Patients with bad breast conservative surgery ( Surgery that impair the cosmetic outcome before starting radiotherapy).
- T4 tumors including inflammatory breast cancer.
- Known definitive clinical or radiologic evidence of metastatic disease.
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- Patients re operated for microscopic positive margins after definitive surgery.
- Previous radiation therapy for the currently diagnosed breast cancer prior to study enrollment
- History of ipsilateral or contralateral breast or thoracic radiotherapy for any condition
- History of ipsilateral or contralateral axillary surgery for any condition
- History of lymphedema involving the ipsilateral or contralateral arm at present or at any time in the past
- Active collagen vascular disease, specifically dermatomyositis with a creatine phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
- Pregnancy or breastfeeding
- Second primary cancer.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mahmoud Ellithy
Cairo, Abbasia, 14031
Mahmoud Ellithy, Phd, 01000069694 ext. 002, ellithym@med.asu.edu.eg
Heba Abdallah, Specialist
About this study
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
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.
Read the detailed description
The investigators hypothesize that hypofractionated radiotherapy in node positive breast cancer is equally effective and safe as conventional fractionated radiotherapy. Breast cancer patients with pathological positive lymph nodes (N1 - N2) operated with modified radical mastectomy will be randomized 1:1 and also those with breast conservative surgery with positive lymph nodes will be randomized 1:1 for receiving either adjuvant conventional radiotherapy 200cgy x 25 fractions with 200cgy x 5 fractions boost for those with intact breast versus hypofractionated radiotherapy 266cgyx16 fractions and 266 cgy x 4 fractions boost for those with intact breast. The patients will be followed for 5 years to monitor locoregional recurrence, cosmetic outcomes, ipsilateral arm lymph edema. Health economic perspectives will be monitored by calculating cost effective analysis for both treatment plans.
- Conditions
- Breast Cancer
- Being tested
- radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapyRadiation
daily fractions, five fractions per week.
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Active comparator | 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. Receives: Radiation: radiotherapy |
| Hypofractionated | Experimental | 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. Receives: Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional recurrence
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.
Measured: 5 years
Cosmetic outcomes
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.
Measured: 5 years
Arm lymph edema.
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.
Measured: 5 years
Health economic perspectives
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionFeb 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Mit Ghamr Oncology Center, Clinical Oncology department. Elmansoura University., Zagazig University, Assiut University, Tanta University, Al-Azhar University, Medical Research Institute. Department of Cancer Management and Research., Cairo University, Clinical Oncology Department. Banha University., Ayadi El Mostakbal Cancer Center. Alexandria.
- Responsible party
- Principal investigator, Mahmoud Ellithy, Ain Shams University
- Investigators
- Mahmoud Ellithy, Phd, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690636
- Sponsor's protocol ID
- Cure and More3
- Status last verified
- May 2016
- First submitted
- 29 Jan 2016
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02690636
- Acronym / sponsor ID
- Cure and More3
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Mit Ghamr Oncology Center, Clinical Oncology department. Elmansoura University., Zagazig University, Assiut University, Tanta University, Al-Azhar University, Medical Research Institute. Department of Cancer Management and Research., Cairo University, Clinical Oncology Department. Banha University., Ayadi El Mostakbal Cancer Center. Alexandria.
- Study start
- Jan 2016
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 24 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators hypothesize that hypofractionated radiotherapy in node positive breast cancer is equally effective and safe as conventional fractionated radiotherapy. Breast cancer patients with pathological positive lymph nodes (N1 - N2) operated with modified radical mastectomy will be randomized 1:1 and also those with breast conservative surgery with positive lymph nodes will be randomized 1:1 for receiving either adjuvant conventional radiotherapy 200cgy x 25 fractions with 200cgy x 5 fractions boost for those with intact breast versus hypofractionated radiotherapy 266cgyx16 fractions and 266 cgy x 4 fractions boost for those with intact breast. The patients will be followed for 5 years to monitor locoregional recurrence, cosmetic outcomes, ipsilateral arm lymph edema. Health economic perspectives will be monitored by calculating cost effective analysis for both treatment plans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | Active comparator | Radiation: radiotherapyThe 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. |
| Hypofractionated | Experimental | Radiation: radiotherapyThe 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- ECOG. (Eastern Cooperative Oncology Group): 0-2
- Histologic documentation of invasive duct or lobular adenocarcinoma of the breast
- If neoadjuvant chemotherapy was NOT administered: pathologic T1-3, N1-2 following definitive surgery
- If neoadjuvant chemotherapy was administered, pathology from the definitive surgery must confirm pathologic T1-3, N1-2 disease and also meet one of the following criteria:
- Clinical T1-3, N1-2 or Pathologic confirmation of axillary nodal involvement at presentation (ie, before neoadjuvant therapy) based on any of the following: Positive fine-needle aspiration (FNA), Positive core needle biopsy.
Key exclusion criteria (14 listed)
- Patients with surgical margins less than or equal to 2mm.
- Patients with axillary dissection of more than 12 lymph nodes due to high incidence of arm lymphedema.
- Women with Huge pendulous breast.
- Patients with bad breast conservative surgery ( Surgery that impair the cosmetic outcome before starting radiotherapy).
- T4 tumors including inflammatory breast cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiotherapydaily fractions, five fractions per week. | Radiation | Conventional, Hypofractionated |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Ellithy, Phd principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing radiotherapy in people with Breast Cancer, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Ellithy, Phd (01000069694 ext. 002, ellithym@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Locoregional recurrence (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2016.