Toxicity and Outcome of Whole Breast Hypofractionated Radiotherapy: a Single Institution Experience (Ipomammella)
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|ClinicalTrials.gov Identifier: NCT03077191|
Recruitment Status : Recruiting
First Posted : March 10, 2017
Last Update Posted : August 31, 2018
|Condition or disease||Intervention/treatment|
|Breast Cancer Quality of Life Radiotherapy; Adverse Effect, Dermatitis or Eczema||Other: Quality of life measurement|
The study is observational, homogeneous (performed in a single institution), non-interventional, and has two parts: one retrospective and one prospective (for which we ask the registration in the register of clinical trials).
The patients with breast cancer treated with adjuvant hypofractionated radiotherapy at the Department of Radiotherapy of "San Raffaele Scientific Institute" (IRCCSSRaffaele) between January 2009 and June 2016 will be identified and their clinical and dosimetric data retrieved and analyzed.
The objectives of the retrospective arm of the study are the analysis with a follow up of 5 years of acute and late toxicity, and clinical outcomes, such as local and regional control, overall survival, disease free survival, cancer-specific survival. A secondary objective is the identification of prognostic factors for toxicity and for the disease progression.
The objective of the prospective arm of the study, for a number of 500 consecutive patients who agree to participate to the study, is to assess the quality of life of the patients treated with hypofractionated short course (3 weeks) radiotherapy. The quality of life questionnaires (QLQ) of European organization for research and treatment of cancer (EORTC), general, QLQ-C30 and, specific for the breast (BR), QLQ-BR23, will be distributed before the radiation treatment, enrollment of the patient, at the end of therapy and during the follow up visits, for a duration of 5 years after the first follow up, scheduled at 6 months and then yearly.
Being an observational non-interventional study, the follow up program of the patients with breast cancer, treated according the standard departmental protocol, will not be modified. The patients will be identified from the patients data base, from the medical records retrieved from the archive of radiotherapy, or alternatively the electronic archive, the pictures monitorising the local evolution from the photo archive. The data will be extracted from medical records. In addition, the dosimetric data of the treatments will be recovered from the physical dosimetric Archives and the extrapolated data related to clinical and toxicity outcomes.
For the patients of the prospective observational arm, the dosimetric data and quality of life questionnaires, asa well as the results of follow up visits will be prospectively collected and registered in a data base, and subsequently analyzed.
The toxicity registered during the visits carried out during the treatment will be determined using the Radiation Therapy Oncology Group (RTOG) scale, and during the follow up visits using the Scoring system of late effects of radiations on normal tissues (SOMA-LENT scale). The clinical point analyzed will be: quality of life, overall survival, disease free-, cancer specific-survival, local and regional control, distant metastases free survival, acute and late toxicity, physical dosimetry and aesthetic results. The detected parameters will be correlated between them, for the identification of prognostic factors. Statistical analyzes will be performed with SPSS software version 17.0 (SPSS Inc. Released 2008. SPSS Statistic for Windows, Version 17.0. Chicago, USA: SPSS Inc.) and MedCalc v.188.8.131.52 (MedCalc Software, Ostend, Belgium) and any updated version. Statistical tests that will be used: uni and multivariate logistic regression to define predictors of incidence and prevalence of toxicity and local/ distant relapses; Cox model ( proportionally-hazard regression) uni- and multi-variate for actuarial analysis of predictors for toxicity and local/ distant relapses; Wilcoxon matched -pair test for the quality of life index variations; Spearman test for the correlation between continuous variables, ANOVA test for the effect of treatment variables on changes in QoL scors over time.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||66 Months|
|Official Title:||Toxicity and Outcome of Whole Breast Hypofractionated Radiotherapy Without Boost: Results of a Homogeneous Single Institution Experience|
|Actual Study Start Date :||November 1, 2016|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||December 31, 2025|
Quality of life
Quality of life of breast cancer patients treated with conservative surgery (quadrantectomy) and adjuvant hypofractionated whole breast radiotherapy according to the institutional standard regimen, to a total dose of 40 Gy in 15 fraction over 3 weeks will be measured with EORTC quality of life questionnaires QLQ-C30 and QLQ-BR 23, before the start of the radiotherapy, at the end of the radiotherapy and then at every follow-up visit ( the first at 6 months after the end of the treatment, then annually for 5 consecutive years after the first follow up visit).
Other: Quality of life measurement
The quality of life of breast cancer patients treated with conservative surgery and adjuvant whole breast hypofractionated radiotherapy, without boost, will be evaluated.
- quality of life [ Time Frame: up to 66 months ]degree of general quality of life worsening of patients treated with hypofractionated adjuvant radiotherapy after breast conserving surgery assessed with EORTC quality of life questionnaires QLQ 30
- quality of life [ Time Frame: up to 66 months ]degree of specific quality of life worsening of patients treated with hypofractionated adjuvant radiotherapy after breast conserving surgery assessed with EORTC quality of life questionnaire QLQ BR23
- local control [ Time Frame: up to 66 months ]percentage of patients without local relapse at five years
- regional control [ Time Frame: up to 66 months ]percentage of patients without regional (axillary, supraclavicular) relapse at five years
- distant metastases free survival [ Time Frame: up to 66 months ]percentage of patients without distant metastases at five years
- disease free survival [ Time Frame: up to 66 months ]percentage of patients without local and/or distant progression at five years
- cancer specific survival [ Time Frame: up to 66 months ]percentage of patients who have not died from breast cancer at five years
- overall survival [ Time Frame: up to 66 months ]percentage of patients alive at five years
- acute toxicity [ Time Frame: up to 66 months ]acute toxicity after hypofractionated whole breast adjuvant radiotherapy evaluated with Radiation Therapy Oncology Group (RTOG) scale at 5 years
- late toxicity [ Time Frame: up to 66 months ]late toxicity after hypofractionated whole breast adjuvant radiotherapy evaluated with Scoring systems of late effects of radiations on normal tissues SOMA-LENT scale at 5 years
- aesthetic result [ Time Frame: up to 66 months ]assessment of the effect of radiation therapy with photographs taken the day of treatment planning verification (before the first radiotherapy fraction), after 15 fractions of radiotherapy (at the end of radiation therapy), and during follow-up visits, the first one at 6 months after the end of radiotherapy and than at 18 months, 30 months, 42 months, 54 months and 66 months after the end of radiotherapy.
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): NCT03077191
|Contact: Andrei Fodor, M.D.||+firstname.lastname@example.org|
|Contact: Marcella Pasetti, M.D.||+email@example.com|
|San Raffaele Scientific Institute||Recruiting|
|Milan, MI, Italy, 20132|
|Contact: Andrei Fodor, M.D. +390226437634 firstname.lastname@example.org|
|Contact: Marcella Pasetti, M.D. +390226435172 email@example.com|