Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Toxicity and Outcome of Whole Breast Hypofractionated Radiotherapy: a Single Institution Experience (Ipomammella)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03077191
Recruitment Status : Recruiting
First Posted : March 10, 2017
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Andrei Fodor, IRCCS San Raffaele

Brief Summary:
This is an homogeneous, single institution, observational, non -interventional, prospective study of 500 patients who will be treated according to the standard protocol of adjuvant hypofractionated radiotherapy after breast conserving surgery, with forward-planned intensity- modulated radiation therapy (IMRT) to a total dose of 40 Gy/ 15 fr (5 fr/ week, 3 consecutive weeks). In addition to the regular follow up, the patients will have to respond to the quality of life questionnaires (QLQ) of European Organisation for Research and Treatment of Cancer (EORTC), general, QLQ- C30, and specific for breast (BR), QLQ- BR23, at the first visit, at the end of radiotherapy ant then at the subsequent follow-up visits form 6 months up to 5 years and a half, to evaluate the quality of life during and after the treatment. The study has also a retrospective arm, the evaluation of disease control and toxicity results in approximately 1300 patients treated from January 2009, when the hypofractionated radiotherapy has been adopted as a standard after breast conserving radiotherapy, up to 2016.

Condition or disease Intervention/treatment
Breast Cancer Quality of Life Radiotherapy; Adverse Effect, Dermatitis or Eczema Other: Quality of life measurement

Detailed Description:

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.12.1.4.0 (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.


Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. local control [ Time Frame: up to 66 months ]
    percentage of patients without local relapse at five years

  2. regional control [ Time Frame: up to 66 months ]
    percentage of patients without regional (axillary, supraclavicular) relapse at five years

  3. distant metastases free survival [ Time Frame: up to 66 months ]
    percentage of patients without distant metastases at five years

  4. disease free survival [ Time Frame: up to 66 months ]
    percentage of patients without local and/or distant progression at five years

  5. cancer specific survival [ Time Frame: up to 66 months ]
    percentage of patients who have not died from breast cancer at five years

  6. overall survival [ Time Frame: up to 66 months ]
    percentage of patients alive at five years

  7. 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

  8. 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


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women with breast cancer
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Breast cancer patients treated with conservative surgery, and whole breast hypofractionated adjuvant radiotherapy.
Criteria

Inclusion Criteria:

  • Breast cancer patients with TNM Classification of Malignant Tumours pathological stage T1-T2, N0-N1a (pathologically node negative - up to three positive lymph-nodes), treated with conservative surgery and whole breast hypofractionated radiotherapy without boost

Exclusion Criteria:

  • male breast cancer patients
  • breast cancer patients treated with conservative surgery and partial breast irradiation, relapsed, and treated with adjuvant whole breast radiotherapy after salvage conservative surgery
  • breast cancer patients treated with mastectomy
  • patients with TNM pathologic stage N1a treated with whole breast radiotherapy and supraclavicular fossa +/- axillary radiotherapy

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Andrei Fodor, M.D. +390226437634 fodor.andrei@hsr.it
Contact: Marcella Pasetti, M.D. +390226435172 pasetti.marcella@hsr.it

Locations
Layout table for location information
Italy
San Raffaele Scientific Institute Recruiting
Milan, MI, Italy, 20132
Contact: Andrei Fodor, M.D.    +390226437634    fodor.andrei@hsr.it   
Contact: Marcella Pasetti, M.D.    +390226435172    pasetti.marcella@hsr.it   
Sponsors and Collaborators
IRCCS San Raffaele

Additional Information:

Publications:
AIRTUM Working Group. I tumoti in Italia- Rapporto 2009. I trend dei tumori negli anni duemila ( 1998-2005). Epidemiol Prev 2009; 33(Suppl 1): 1-168.
http://www.istat.it/dati/dataset/20100129_00/
https://www.nccn.org/professionals/physician_gls/f_guidelines

Layout table for additonal information
Responsible Party: Andrei Fodor, M.D., IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT03077191     History of Changes
Other Study ID Numbers: Ipomammella
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual Participant Data will not be shared with other researchers.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrei Fodor, IRCCS San Raffaele:
hypofractionated whole breast radiotherapy
breast cancer
conservative treatment
quality of life
Additional relevant MeSH terms:
Layout table for MeSH terms
Dermatitis
Skin Diseases