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Prospective randomized study comparing 5 fractions in alternative days to standard 15 fractions regarding effectiveness and feasibility during adjuvant treatment in breast caner patients aged above 50 years
In Alexandria, the number of working linear machines are limited with overcrowded waiting list which lead to prolongation of overall treatment time and delay in starting radiotherapy. Providing the available data, Principle investigator is conducting this study in parallel with fast forward protocol to provide an alternative cost effective approach to patients.
The rationale behind hypofractionation depends mainly on the alpha beta ratio (α/β) and the overall treatment time. In Breast cancer the ratio is around 4 which is slightly lower than other tumors such as head and neck. The lower the ratio the higher the dose per fraction is needed to compensate slower proliferating tumors. Also, the overall treatment time could affect the local recurrence of breast cancer which is increased with long duration of treatment.
This study will include at least 100 patients with non metastatic histologically proved breast cancer who are indicated for adjuvant radiotherapy.
The patients will be randomized into two arms:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionation | Active Comparator | Control arm:patients who will receive standard 40.05 Gray (2.67 Gy/ fx) over 15 fractions with or without boost over 3 weeks |
|
| Ultrahypofractionation | Experimental | Experimental arm: Patients who will receive 26 Gray (5.2 Gy/fx) over 5 fractions over 1.5 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionation | Radiation | 3D conformal Radiotherapy whole breast irradiation +- Supraclavicular fossa using Linear Machine (6-15 MV energy) 40.05 Gray (2.67 Gy/ fx) over 15 fractions with or without boost over 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Acute grade 2 or higher toxicity (NCI-CTCAE) | Each patient will be assessed weekly during radiotherapy and monthly for three months post radiotherapy to assess acute toxicity and will be documented according to Common Terminology Criteria for adverse events (CTCAE) | Start of treatment till 3 months from end of treatment |
| Rate of chronic Toxicity grade 2 or higher (NCI-CTCAE) | Each patient will be assessed before treatment and at 6 , 12 , 24 months for chronic toxicity Criteria for adverse events (CTCAE) | Before start treatment and from 6 months after finishing treatment every 6 months up to average 2 years |
| Rate of Ipsilateral local tumor recurrence | Local recurrence proved by image and biopsy | 1 to 2 years |
| Compliance to treatment (number of interrupted days of radiation) | Treatment interruptions of planned cycles | Start treatment till end of treatment (2 weeks in arm one and 3 weeks in arm2) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | the percentage of people in a study or treatment group who are alive two years after the start of treatment. | From date of diagnosis up to average 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amr Munir | Contact | +201227241185 | dr.amr.munir@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ashraf M El-Enbaby, Prof | Alexandria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ACOD | Recruiting | Alexandria | Egypt |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000069473 | Radiation Dose Hypofractionation |
| ID | Term |
|---|---|
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| ultraHypofractionation | Radiation | 3D conformal Radiotherapy whole breast irradiation +- Supraclavicular fossa using Linear Machine (6-15 MV energy) 26 Gray (5.2 Gy/fx) over 5 fractions over 1.5 weeks |
|
| D017437 |
| Skin and Connective Tissue Diseases |