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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 or without HYPErthermia or surgery only: Toxicity, quality of life and survival in patients with locoregional recurrent breast cancer (RT-HYPE).

Indication

  • Locoregional

Description

Postoperative re-irradiation with and without hyperthermia or surgery only: toxicity, quality of life and survival in patients with locoregional recurrent breast cancer

Target sample size

500

Actual accrual

130
Date: 31/03/2026

Number of active sites

9

Contact

Sponsor

Amsterdam UMC, locatie Vumc

Principal Investigator(s)

Dr. H.J.G.D. van den Bongard, radiotherapeut-oncoloog, Amsterdam UMC

Co-PI’s:

  • Dr. M. van Maaren, epidemioloog, Universiteit Twente
  • Dr. F. van Duijnhoven, chirurg, Antoni van Leeuwenhoek
  • Dr. H. Crezee, fysicus, Amsterdam UMC
  • Dr. S. Curto Ramos, fysicus, Erasmus MC
  • Dr. A. Bakker, technisch geneeskundige, PMC

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 registration

IKNL Clinical Research Department
Central Data Manager: A. Komurcu
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 
  • Catharina Ziekenhuis Eindhoven
  • Erasmus MC Rotterdam 
  • Institute Verbeeten Tilburg 
  • Maastro Clinic (Maastricht) 
  • Radboud UMC (Nijmegen) 
  • Radiotherapy Group (Arnhem/Deventer) 
  • UMC Groningen 
  • UMC Utrecht 

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

  • Patients diagnosed with local +/- regional recurrence (LRR) with high-risk tumor characteristics and previously treated with postoperative local +/- regional irradiation for primary breast cancer/previous recurrence with an indication for salvage mastectomy with/without postoperative re-irradiation (+/-hyperthermia).
  • Patients diagnosed with a chest wall recurrence and treated with local excision with/without NAST and postoperative re-irradiation with/without hyperthermia. In patients with a clinical/radiological complete response after neoadjuvant systemic treatment, NO surgery and re-irradiation (+/- hyperthermia) (since surgery is not possible in this group).
  • (Neo)adjuvant systemic therapy (NST) is allowed.
  • Use of (FES/FDG-)PET-CT in 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) are allowed.

Regulatory Information

METC approval:
Not applicable

Public Downloads

Verkorte PIF RT-HYPE (31-03-2026)

Downloads

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