Clinical trial NCT02505906: Late Toxicity in Breast Cancer Patients Treated With Breast-conserving Surgical Procedures and Radiotherapy Using the Simultaneous Integrated Boost Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Late toxicity
Simultaneous integrated boost (SIB)
Radiotherapy
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2015-07-22
Enrollment: 5043
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with breast cancer treated with curative intent.

Brief summary: In summary, breast conserving therapy (BCT) is an effective, save and widely used treatment technique for early breast cancer. Radiotherapy has shown to give better local control and survival benefit and is an integrated part of BCT. The simultaneous integrated boost (SIB) technique is a new treatment technique in breast irradiation. In this technique the whole breast is irradiated simultaneous with boosting the tumour bed, as part of BCT. Late radiation-induced toxicity has not been investigated in patients treated with radiotherapy using this technique. Proposed study will study the late radiation-induced toxicity, describe patients-rated complaints, quality of life, survival and local control curves in patients treated for early breast cancer with breast-conserving surgery in combination with radiotherapy with the SIB technique as compared to sequential radiotherapy treatment.


Eligibility criteria: Inclusion Criteria:

* WHO performance status 0-2.
* Invasive breast cancer or ductal carcinoma in situ (DCIS).
* Stage I-III breast cancer or DCIS.
* Treated with curative radiotherapy of the breast (as part of breast conserving therapy) with simultaneous integrated boost technique, with or without irradiation of the regional (including internal mammary) lymph nodes.

Exclusion Criteria:

* Previous thoracic radiotherapy.
* Previous history of malignancy, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin.
* Bilateral (synchrone) invasive breast cancer.
* Treatment prior to surgery (i.e. neoadjuvant chemotherapy, neoadjuvant hormonal therapy, pre-operative radiotherapy).
* Distant metastases at diagnosis (M1).
* Unsufficient knowledge of Dutch language.

Primary outcomes:
measure: Late radiation-induced toxicity (grade 2 or higher)
timeFrame: At 1 year after completion of radiation therapy
measure: Late radiation-induced toxicity (grade 2 or higher)
timeFrame: At 2 years after completion of radiation therapy
measure: Late radiation-induced toxicity (grade 2 or higher)
timeFrame: At 3 years after completion of radiation therapy
measure: Late radiation-induced toxicity (grade 2 or higher)
timeFrame: At 4 years after completion of radiation therapy
measure: Late radiation-induced toxicity (grade 2 or higher)
timeFrame: At 5 years after completion of radiation therapy
Secondary outcomes:
measure: Overall survival
timeFrame: At 1,2,3,4 and 5 years after completion of radiation therapy
measure: Patient-rated symptoms
timeFrame: At 1,2,3,4 and 5 years after completion of radiation therapy
measure: Quality of life in breast cancer patients treated with radiotherapy after breast conserving surgery
timeFrame: At 1,2,3,4 and 5 years after completion of radiation therapy
measure: Recurrence (local)
timeFrame: At 1,2,3,4 and 5 years after completion of radiation therapy
measure: Recurrence (regional)
timeFrame: At 1,2,3,4 and 5 years after completion of radiation therapy
measure: Recurrence (distant metastasis)
timeFrame: At 1,2,3,4 and 5 years after completion of radiation therapy
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References: