Trial Details
Trial status:
In set-up (funded)
Recruitment start date:
04/03/2024
Funder:
NIHR/HTA
Sponsor:
UCL
Chief Investigator:
Emma Crosbie and Melanie Powell
Recruitment target:
600
EudraCT number:
Contact details:
ctc.NSMP-ORANGE@ucl.ac.uk
Note: For enquiries only. DO NOT use for clinical referrals.
Lay summary:
NSMP-ORANGE
RAINBO NSMP - ORANGE: Refining Adjuvant treatment IN endometrial cancer Based On molecular features (RAINBO) TransPORTEC platform trials. RAINBO - Non Specific molecular profile (NSMP) - ORANGE trial
Description
Design: NSMP-ORANGE is a phase III, randomised controlled trial of chemoradiation against radiotherapy with hormone therapy in patients with endometrial cancer.
Treatment: Patients will be randomised to receive current standard of care chemoradiation (2 cycles of cisplatin during radiotherapy followed by 4 cycles of carboplatin and paclitaxel) or 4 weeks of radiotherapy followed by oral progestin for 2 years. 
Key inclusion/exclusion criteria:

Inclusion

  1. Written informed consent
  2. Histologically confirmed diagnosis of endometrial cancer
  3. Hysterectomy and bilateral salpingo-oophorectomy
  4. No distant metastases
  5. Aged 18 or over
  6. Donation of tissue block
  7. p53 wildtype, MMR proficient with no somatic pathogenic POLE variant (i.e NSMP)
  8. ER+ by ICH
Exclusion

  1. History of another primary malignancy
  2. Prior pelvic radiation
  3. Contraindication to trial medication


Duration of recruitment: 5 years
Aim
NSMP-ORANGE aims to investigate whether adjuvant radiotherapy with maintenance progestin tablets is as effective as chemoradiotherapy, whilst reducing toxicity and thus improving quality of life, in patients with high-risk NSMP endometrial cancer.
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

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