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Completed

NCT Number: NCT01276938

Exclusive Intraoperative Radiation Therapy for Breast Cancer

Aim of the study is to evaluate toxicity in breast cancer patients treated with two different doses of Intra Operative Radiotherapy

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Toxicity

Age range

45 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

IRCCS AOU San Martino- IST

Genoa, 16132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non lobular epithelial breast carcinoma, excised with standard quadrantectomy
  • Age ≥ 45 and < 85
  • Tumor major diameter ≤ 2.5 cm
  • Negative surgical margins (≥ 5 mm)
  • Willingness to undergo follow up examinations
  • Willingness to undergo imaging examinations (MRI, mammograms, ultrasonography)
  • Signed informed consent

Exclusion criteria

  • Ductal carcinoma in situ or lobular carcinoma
  • Extensive intraductal component (greater than 25%) or intraductal carcinoma with microinvasion
  • Serious concomitant disease or any disorder or condition (such as psychiatric or addictive disorders) that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
  • Pregnancy or lactation at the time of enrolment proposal (if necessary, during the trial patients must use effective contraceptive device)
  • Collagen vascular disorders

Treatment and study plan

21 Gy radiation

Radiation

21 Gy radiation using electrons produced with mobile linear accelerator (energies ranging from 4 to 10 MeV)

18 Gy radiation

Radiation

18 Gy radiation using electrons produced with mobile linear accelerator (energies ranging from 4 to 10 MeV)

Primary outcomes

  1. Early toxicity

    Time frame: 6 months

    Assessment of early toxicity using modified RTOG scale

  2. Late toxicity

    Time frame: 5 years

    Assessment of late toxicity using modified LENT scale

  3. Cosmetic outcome

    Time frame: 5 years

    Assessment of cosmetic outcome according to semi-objective criteria

Secondary outcomes

  1. Local Relapse Free Survival (LRFS)

    Time frame: 10 years

    Local recurrence rate will be continuously monitored in order to stop the trial in case results will be consistently worse than expected according to literature data

  2. Disease Free Survival (DFS)

    Time frame: 10 years

    Disease Free Survival will be continuously monitored in order to stop the trial in case results will be consistently worse than expected according to literature data

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Other

Registry information

Official study title

Tolerance Evaluation of Exclusive Intraoperative Radiation Therapy at Different Doses for Breast Cancer Conservative Treatment

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 14, 2011
Registry last updated
May 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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