Recruitment

Recruitment Status
Completed
Estimated Enrollment
100

Inclusion Criterias

Treatment with primary breast-sparing surgery (lumpectomy) and/ or neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy or hormonal treatment
Provide signed informed consent
Scheduled for postoperative radiotherapy with standard technique (isocentric) and fractionation regime (i.e., 25 daily fractions to the whole breast followed by a boost of 8 fractions to the tumor bed, 2 Gy per fraction, five times per week)
...
Treatment with primary breast-sparing surgery (lumpectomy) and/ or neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy or hormonal treatment
Provide signed informed consent
Scheduled for postoperative radiotherapy with standard technique (isocentric) and fractionation regime (i.e., 25 daily fractions to the whole breast followed by a boost of 8 fractions to the tumor bed, 2 Gy per fraction, five times per week)
Diagnosis of noninvasive (Stage 0) or invasive (Stages 1, 2 or 3A) breast adenocarcinoma

Exclusion Criterias

Mastectomy surgery
Metastatic disease
Required use of bolus material to deliver radiation therapy (i.e., material placed on the to-be-irradiated zone to modulate the delivered dose in order to ensure an optimal distribution of the radiation dose)
...
Mastectomy surgery
Metastatic disease
Required use of bolus material to deliver radiation therapy (i.e., material placed on the to-be-irradiated zone to modulate the delivered dose in order to ensure an optimal distribution of the radiation dose)
Concurrent chemo-radiotherapy
Previous irradiation to the same breast

Summary

Conditions
Radiation Dermatitis
Type
Interventional
Design
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Younger than 125 years
Gender
Only females

Inclusion Criterias

Treatment with primary breast-sparing surgery (lumpectomy) and/ or neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy or hormonal treatment
Provide signed informed consent
Scheduled for postoperative radiotherapy with standard technique (isocentric) and fractionation regime (i.e., 25 daily fractions to the whole breast followed by a boost of 8 fractions to the tumor bed, 2 Gy per fraction, five times per week)
...
Treatment with primary breast-sparing surgery (lumpectomy) and/ or neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy or hormonal treatment
Provide signed informed consent
Scheduled for postoperative radiotherapy with standard technique (isocentric) and fractionation regime (i.e., 25 daily fractions to the whole breast followed by a boost of 8 fractions to the tumor bed, 2 Gy per fraction, five times per week)
Diagnosis of noninvasive (Stage 0) or invasive (Stages 1, 2 or 3A) breast adenocarcinoma

Exclusion Criterias

Mastectomy surgery
Metastatic disease
Required use of bolus material to deliver radiation therapy (i.e., material placed on the to-be-irradiated zone to modulate the delivered dose in order to ensure an optimal distribution of the radiation dose)
...
Mastectomy surgery
Metastatic disease
Required use of bolus material to deliver radiation therapy (i.e., material placed on the to-be-irradiated zone to modulate the delivered dose in order to ensure an optimal distribution of the radiation dose)
Concurrent chemo-radiotherapy
Previous irradiation to the same breast

Locations

Hasselt, B-3500
Hasselt, B-3500

Tracking Information

NCT #
NCT01932073
Collaborators
Not Provided
Investigators
  • Principal Investigator: Jeroen Mebis, MD, PhD Jessa Hospital
  • Jeroen Mebis, MD, PhD Jessa Hospital