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ADELE : The effect of adjuvant tislelizumab plus chemotherapy on failure free survival after post-operative pelvic chemoradiation in high risk endometrial cancer - ADELE: a randomised phase 2 trial

Female<br/>OnlyGender Female
Only

RecruitingStatus Recruiting

Radiotherapy<br/>TrialTypeRadiotherapy
Trial

TwoPhase Two

18+Age Over 18

Female Reproductive<br/>System CancersCancer LocationFemale Reproductive
System Cancers

Radiotherapy,Systemic therapy | Female reproductive organsEndometrium

Trial Overview Read MoreRead more

This phase II study is evaluating the effectiveness of pelvic chemoradiation therapy, followed by chemotherapy (carboplatin and paclitaxel), with or without immunotherapy (tislelizumab), in people with endometrial cancer who have had surgery.
 

This trial is treating patients with endometrial cancer.

This is a systemic and radiation therapy trial.

You may be able to join this trial if:

  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

The effect of adjuvant tislelizumab plus chemotherapy on failure free survival after post-operative pelvic chemoradiation in high risk endometrial cancer - ADELE: a randomised phase 2 trial

Cooperative Group

Australia New Zealand Gynaecological Oncology Group (ANZGOG)

Other Non-Commercial Sponsor

University of Sydney

Summary

Eligible participants will be randomly allocated to either the Experimental Arm or Active Comparator Arm. In the Experimental Arm, participants will receive sequential adjuvant treatment of pelvic chemoradiation, followed by 4 cycles of tislelizumab and carboplatin plus paclitaxel chemotherapy, followed by tislelizumab alone for another 8 cycles. In the Active Comparator Arm, participants will receive a sequential adjuvant treatment of pelvic chemoradiation, followed by 4 cycles of carboplatin plus paclitaxel chemotherapy. Pelvic chemoradiation should commence within 4-6 weeks after surgery, but no later than 8 weeks, and prior to chemotherapy +/- immunotherapy. Pelvic chemoradiation will be at a dose of 45Gy in 25 fractions, delivered to the clinical target volume 5 days a week for 5 weeks. Tislelizumab (200mg) will be be administered via intravenous infusion (IV) once every 3 weeks for up to 12 cycles, and carboplatin (AUC 5) and paclitaxel (175mg/m^2) will also be administered via IV once every 3 weeks.

Recruiting Hospitals Read MoreRead more

Monash Health, Medical Oncology
Clayton
Breast and Gynaecology Research Study Coordinator
breastgynae.oncresearch@monashhealth.org
0491299561

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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