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临床试验/NL-OMON54178
NL-OMON54178招募中3 期

RAINBO: Refining Adjuvant treatment IN endometrial cancer Based On molecular features, MMRd-GREEN trial - RAINBO MMRd-GREE

eids Universitair Medisch Centrum0 个研究点目标入组 150 人开始时间: 待定最近更新:
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试验速览

阶段
3 期
状态
招募中
入组人数
150
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99（—）

入选标准

  • •Inclusion criteria for the RAINBO program:
  • •Histologically confirmed diagnosis of EC of the following histologic
  • •subtypes: endometrioid endometrial carcinoma, serous endometrial carcinoma,
  • •uterine clear cell carcinoma, dedifferentiated and undifferentiated endometrial
  • •carcinoma, uterine carcinosarcoma, and mixed endometrial carcinomas of the
  • •aforementioned histotypes.
  • •Full molecular classification performed following the diagnostic algorithm
  • •described in WHO 2020 (5th Edition, IARC, Lyon, 2020, adapted from Vermij et
  • •TLH-BSO or TAH-BSO with or without lymphadenectomy and/or full surgical
  • •staging, 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
  • •Patients must be accessible for treatment and follow-up
  • •Written informed consent for participation in one of the RAINBO trials,
  • •permission for the contribution of a tissue block for translation research and
  • •permission for the use and sharing of data for the overarching research project
  • •according to the local Ethics Committee requirements.
  • •Inclusion criteria specific for MMRD-Green trial:
  • •Written informed consent
  • •WHO Performance score 0-1
  • •Histologically confirmed Stage III EC or stage IB/II EC with substantial LVSI
  • •Molecular classification: MMRd EC
  • •No prior pelvic radiotherapy
  • •Body weight > 30 kg
  • •Adequate systemic organ function:
  • •o 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 determination of
  • •creatinine clearance.
  • •o Adequate bone marrow function : hemoglobin >9.0 g/dl, Absolute neutrophil
  • •count (ANC) >=1.0 x 109/l, platelet count >=75 x 109/l.
  • •o Adequate liver function:
  • •bilirubin <=1.5 x institutional upper limit of normal (ULN). <apply to patients with confirmed Gilbert*s syndrome (persistent or recurrent
  • •hyperbilirubinemia that is predominantly unconjugated in the absence of
  • •hemolysis or hepatic pathology), who will be allowed only in consultation with
  • •their physician.>>
  • •ALT (SGPT) and/or AST (SGOT) <=2.5 x ULN

排除标准

  • •Exclusion criteria for RAINBO program
  • •History of another primary malignancy, except for non-melanoma skin cancer,
  • •in the past 5 years
  • •Prior pelvic irradiation
  • •Exclusion criteria specific for MMRd-GREEN trial:
  • •Major surgical procedure (as defined by the Investigator) within 28 days
  • •prior to the first dose of IP.
  • •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 lung
  • •disease, serious chronic gastrointestinal conditions associated with diarrhea,
  • •or psychiatric illness/social situations that would limit compliance with study
  • •requirement, substantially increase risk of incurring AEs or compromise the
  • •ability of the patient to give written informed consent.
  • •Any previous treatment with a PD1 or PD-L1 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 IP.
  • •Current or prior use of immunosuppressive medication within 14 days before
  • •the first dose of durvalumab with the exceptions of :
  • •- Intranasal, inhaled, topical steroids, or local steroid injections (e.g.,
  • •intra articular injection).
  • •- Systemic corticosteroids at physiologic doses not to exceed <<10 mg/day>> of
  • •prednisone or its equivalent
  • •- Steroids as premedication for hypersensitivity reactions (e.g., CT scan
  • •premedication).
  • •History of active primary immunodeficiency
  • •Active or prior documented autoimmune or inflammatory disorders (including
  • •inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis
  • •[with the exception of diverticulosis], systemic lupus erythematosus,
  • •Sarcoidosis syndrome, or Wegener syndrome. The following are exceptions to this
  • •- 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 surface
  • •antigen (HBsAg) result), hepatitis C, or human immuno-deficiency virus
  • •(positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection
  • •(defined as the presence of hepatitis B core antibody [anti-HBc] and absence of
  • •HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are
  • •eligible only if polymerase chain reaction is negative for HCV RNA.
  • •Known allergy for durvalumab.
  • •Medical or psychological condition which in the opinion of the investigator
  • •would not permit the patient to complete the study or sign meaningful informed

研究者

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