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RT-HYPE

  • Open

BOOG 2023-01

General Information

BOOG number

BOOG 2023-01

Nickname

RT-HYPE

Status

  • Open
Date: 01/02/2024

Full title

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

34
Date: 18/11/2024

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 

Regulatory Information

METC approval:
Not applicable

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