Postoperative Re-irradiaTion with and without HYPERthermia: Toxicity, quality of life and survival in patients with locoregional recurrent breast cancer
Indication
Locoregional
Description
Postoperative re-irradiation with and without hyperthermia
Target sample size
500
Actual accrual
35
Date: 21/11/2024
Number of active sites
6
Contact
Sponsor
Amsterdam UMC, locatie Vumc
Principal Investigator(s)
Dr. H.J.G.D. van den Bongard
Study manager
BOOG Study Center: Dr. A.E. van Leeuwen-Stok (CSM), C. Wolters-Verweij (PM)
Study coordinator
Drs. L. Wurfbain, arts onderzoeker, AUMC, locatie Vumc
Central datamanagement and randomization
IKNL Clinical Research Department
Central Data Manager: L. Mol
e: trialbureau@iknl.nl
t: 088 234 6500
Monitoring
IKNL Clinical Research Department
Monitor: A. Hogeman/A. Ruhl
e: monitor@iknl.nl t: 088 234 6500
Local datamanagement
IKNL Clinical Research Department
e: trialbureau@iknl.nl t: 088 234 6500
Funding
KWF/Pink Ribbon
Other
Submitted to METC Amsterdam UMC dd 14-12-2023 and judged being not applicable to WMO registration
Design
National multicenter observational prospective cohort study
Participating sites
Amsterdam UMC (open for inclusion)
Catharina Ziekenhuis Eindhoven (open for inclusion)
Erasmus MC Rotterdam (open for inclusion)
Institute Verbeeten Tilburg (open for inclusion)
Maastro Clinic(Maastricht) (open for inclusion)
Radboud UMC(Nijmegen) (in preparation)
Radiotherapy Group(Arnhem/Deventer) (open for inclusion)
UMC Groningen (in preparation)
UMC Utrecht (in preparation)
Endpoints
Primary endpoint: Patient-reported toxicity according to PRO-CTCAE after a median follow-up of five years after diagnosis of (subsequent) LRR disease.
Secondary endpoints:
Quality of Life (EORTC-C30 and –BR45). LRR-free, distant metastasis-free, breast-cancer event-free and overall survival at 2 and 5 years after diagnosis of LRR disease.
Referral patterns (per institute, professional, patient-related factors including performance status, and travel distance).
Eligibility Criteria
Diagnosed with a LRR breast cancer after postoperative irradiation of the primary breast cancer
≥ 18 years old
WHO performance scale ≤ 2
Diagnosed with a second primary ipsilateral breast cancer will also be included (according to current clinical practice)
Treated with local excision after previous mastectomy
Treated with salvage mastectomy with high-risk tumor characteristics or local excision with an indication for postoperative re-irradiation
(Neo-)adjuvant systemic (NAST) treatment is allowed
Use of PET(FES/FDG)-CT for staging of nodal and disseminated disease
Oligometastases in lymph nodes in the mediastinum, neck, contralateral axillary/supraclavicular region (up to a maximal number of five) is allowed
Proficient in Dutch at a level allowing to understand the questionnaires and patient information sheet