Clinical trial for Endometrial Cancer
Official title Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features
ClinicalTrials.gov ID: NCT05255653
What this study is testing
What is Chemotherapy?
This is an investigational combination of drugs being studied as a potential treatment for endometrial cancer. It is designed to kill rapidly dividing cancer cells or stop them from growing.
Also referred to as Cisplatin, Carboplatin, Paclitaxel.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if adding durvalumab to standard radiation therapy improves outcomes for patients with specific types of endometrial cancer.
- Who it's for
- The study is looking for people with endometrial cancer that has specific molecular features, such as mismatch repair deficiency.
- What's involved
- Participants will receive pelvic radiation therapy. Some will also take durvalumab for one year, while others may receive chemotherapy or radiation alone.
- Time commitment
- The treatment involves one year of durvalumab if assigned to that group, along with standard radiation visits.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Participants of the four RAINBO trials should be eligible according to the inclusion and
You likely can't join if
- Histologically confirmed diagnosis of endometrial cancer (EC) of the following histotypes: endometrioid endometrial carcinoma, serous endometrial...
- Full molecular classification performed following the diagnostic algorithm described in WHO 2020 (5th Edition, IARC, Lyon, 2020)
- TLH-BSO or TAH-BSO with or without lymphadenectomy or sentinel node biopsy, without macroscopic residual disease after surgery
- No distant metastases as determined by pre-surgical or post-surgical imaging (CT/MRI scan of chest, abdomen and pelvis or PET-CT scan)
- Age ≥ 18 years
- Expected start of adjuvant treatment (if applicable) within 10 weeks after surgery
See the full eligibility criteria
- Participants of the four RAINBO trials should be eligible according to the inclusion and
- Histologically confirmed diagnosis of endometrial cancer (EC) of the following histotypes: endometrioid endometrial carcinoma, serous endometrial carcinoma, uterine clear cell carcinoma, dedifferentiated and...
- Full molecular classification performed following the diagnostic algorithm described in WHO 2020 (5th Edition, IARC, Lyon, 2020)
- TLH-BSO or TAH-BSO with or without lymphadenectomy or sentinel node biopsy, without macroscopic residual disease after surgery
- No distant metastases as determined by pre-surgical or post-surgical imaging (CT/MRI scan of chest, abdomen and pelvis or PET-CT scan)
- Age ≥ 18 years
- Expected start of adjuvant treatment (if applicable) within 10 weeks after surgery
- Patients must be accessible for treatment and follow-up
- History of another primary malignancy, except for non-melanoma skin cancer, in the past 5 years
- Written informed consent
- WHO Performance score 0-1
- Histologically confirmed FIGO 2009 stage IB/II with LVSI, stage III, or stage IV with limited pelvic peritoneal involvement (FIGO 2023 stage IB with LVSI, stage II with myometrial or cervical stroma involvement and...
- Molecular classification: MMRd EC\
- No prior pelvic radiotherapy
- Body weight \> 30 kg
- Creatinine clearance (\> 40 cc/min): Measured creatinine clearance (CL) \>40 mL/min or Calculated creatinine CL\>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for...
- Adequate bone marrow function : hemoglobin \>9.0 g/dl, Absolute neutrophil count (ANC) ≥1.0 x 109/l, platelet count ≥75 x 109/l.
- Adequate liver function: Bilirubin ≤1.5 x institutional upper limit of normal (ULN). \ \>
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of Investigational medicinal product (IMP).
- History of allogenic organ transplantation.
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial...
- Any previous treatment with a PD(L)1 inhibitor, including durvalumab.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IMP.
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection).
- Systemic corticosteroids at physiologic doses not to exceed \ \> of prednisone or its equivalent.
- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
- History of active primary immunodeficiency
- Patients with vitiligo or alopecia
- Patients with hypothyroidism (e.g., following Hashimoto syndrome)stable on hormone replacement
- Any chronic skin condition that does not require systemic therapy
- Patients without active disease in the last 5 years may be included but only after consultation with the study physician.
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV...
- Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.
The study team makes the final eligibility decision.
Where it is enrolling
- Antwerp, Belgium
- Brussels, Belgium
- Charleroi, Belgium
- Mons, Belgium
- Namur, Belgium
- Ostend, Belgium
- Hamilton, Canada
- Kelowna, Canada
- Kingston, Canada
- London, Canada
- Montreal, Canada
- Regina, Canada
- Saint John, Canada
- Saskatoon, Canada
- Sherbrooke, Canada
- Toronto, Canada
- Vancouver, Canada
- Victoria, Canada
- Hradec Králové, Czechia
- Prague, Czechia
+ 32 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Antwerp, Belgium; Brussels, Belgium; Charleroi, Belgium; Mons, Belgium; Namur, Belgium; Ostend, Belgium and 46 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.