Hypofractionated Versus Conventional Fractionation Radiotherapy
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|ClinicalTrials.gov Identifier: NCT04015531|
Recruitment Status : Not yet recruiting
First Posted : July 11, 2019
Last Update Posted : July 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Radiation Toxicity||Radiation: Conventional radiotherapy Radiation: Hypofractionated radiotherapy||Not Applicable|
Investigators hypothesize that hypofractionated radiotherapy is equal effective and safe as conventional radiotherapy in breast cancer patients undergoing regional nodal irradiation.
Eligible breast cancer patients are randomized 1:1 into the following two groups:
- Hypofractionated therapy: 40 Gy in 15 fractions of 2.67 Gy in breast or chest wall and nodal drainage with Concurrent boost 48.0 Gy / 3.2 Gy daily in tumor bed, in case of conservative surgery;
- Standard fractionation: 50 Gy in 25 fractions in breast or chest wall and nodal drainage with sequential tumor bed boost with 10 Gy in 5 fractions in tumor bed in case of conservative surgery.
Patients will be followed for 6 months after radiotherapy to evaluate acute toxicity and quality of life.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Radiation toxicity will be analysed by a blind second investigator.|
|Official Title:||Hypofractionated Versus Conventional Fractionation Radiation After Conservative Surgery or Mastectomy With Irradiation of Lymph Node Drainage: a Phase II Randomized Clinical Trial for the Evaluation of Acute Toxicity|
|Estimated Study Start Date :||July 2019|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||December 2020|
Active Comparator: Conventional radiotherapy
50 Gy in 25 fractions to chest wall or whole breast and regional lymph regions (supraclavicular fossa with or without axilla), followed by tumor bed boost of 10 Gy in 5 fractions in case of breast conserving surgery.
Total time: 5-6 weeks.
Radiation: Conventional radiotherapy
50 Gy / 25 fractions / 5-6 weeks / Sequential boost of 10 Gy in 5 fractions, in case of conservative surgery.
Other Name: Standard fractionation
Experimental: Hypofractionated radiotherapy
40 Gy in 15 fractions (2.67 Gy each) to chest wall or whole breast and regional lymph regions (supraclavicular fossa with or without axilla).
Patients undergoing breast conserving surgery will receive concomitant boost with total dose of 48 Gy in 15 fractions (3.20 Gy each) to tumor bed.
Total time: 3 weeks.
Radiation: Hypofractionated radiotherapy
40 Gy / 15 fractions / 3 weeks / Concomitant boost with total dose of 48 Gy in 15 fractions, in case of conservative surgery.
Other Name: Hypofractionated therapy
- CTCAE Toxicity Assessement - Acute Toxicity [ Time Frame: Before treatment, every week of treatment (week 1 to 3 or 1 to 5-6, according to the treatment arm), at the end of treatment (week 3 or week 5-6, according to the treatment arm), 4, 8 and 24 weeks after the last fraction received. ]Change in acute toxicity will be assessed according to criteria of CTCAE version 4.03.
- Quality of Life - EORTC QLQ-C30 (version 3) [ Time Frame: Before treatment, at the end of treatment (week 3 or week 5-6, according to the treatment arm),1 and 6 months after last fraction received. ]Patients' quality of life will be assessed using self-administered questionnaire EORTC-QLQ-C30 (version 3).
- Quality of Life - EORTC breast cancer module (BR23) [ Time Frame: Before treatment, at the end of treatment (week 3 or week 5-6, according to the treatment arm),1 and 6 months after last fraction received. ]Patients' quality of life will be assessed using self-administered questionnaire EORTC breast cancer module (BR23).
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): NCT04015531
|Contact: Gabriel Oliveira B Gil, MD||55 31 email@example.com|
|Contact: Darly GS Delfino, MSc||55 31 firstname.lastname@example.org|
|Principal Investigator:||Gabriel Oliveira B Gil, MD||Baleia Hospital|