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NCT05489848Not yet recruitingPhase 2/3

Chemotherapy vs Chemoradiotherapy for Post-operative Endometrial Cancer Patients With P53-mutation

Chemotherapy Versus Chemoradiotherapy on the Prognosis for Postoperative Endometrial Cancer With P53-mutation Profile: a Non-inferiority Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 5 Aug 2022 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Aim to compare chemotherapy alone or chemoradiotherapy for post-operative endometrial cancer (stage I-IVA) with p53 mutation.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
294 (estimated)
First submitted
4 Aug 2022
Start date
20 Aug 2022
Primary completion date
20 Aug 2028
Lead sponsor
Fudan University
NCT number
NCT05489848

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 294
  • From 20 Aug 2022 to the primary completion date, 20 Aug 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 1\) Tumors from uterine stroma,
    • 2\) Recurrent endometrial malignant tumor,
    • 3\) Those who have received other anti-tumor treatments within half a year before surgery: including neoadjuvant chemotherapy, hormone therapy, target therapy, immunotherapy, and biological therapy,etc.
    • 4\) Those in pregnancy and perinatal period,
    • 5\) Concurrent with other malignant tumors of reproductive system or non-reproductive system,
    • 6\) History of important organ transplantation,
    • 7\) Those who need to take immunosuppressants with a history of immune diseases,
    • 8\) History of severe mental illness and brain dysfunction,
    • 9\) History of drug abuse or drug use,
    • 10\) Participants in other clinical trials at the same time,
    • 11\) Those who are unable or unwilling to receive postoperative adjuvant chemotherapy or radio-chemotherapy/sign the informed consent form/comply with the research requirements,
    • 12\) Patients of any stage who are excluded or unable to tolerate radiotherapy and chemotherapy after evaluation without indication of radiotherapy.

Who the study is looking for

  • 1)Age ≥18 years,
    • 2\) Patients with stage I-IVA (FIGO2009) (excluded endometrial epithelial carcinoma confined to the endometrial layer), which have received initial diagnosis and comprehensive staging surgery (based on total uterine and double salpingectomy. Lymph nodes are evaluated by at least a sentinel lymph node biopsy), regardless of the pathological type, at the same time, the molecular typing of preoperative endometrial biopsy or total hysterectomy should be type p53mut.
    • 3)The duration of postoperative adjuvant therapy after initiation shall not exceed 8 weeks after enrollment,
    • 4)There is no obvious abnormality in the function of important organs, and the relevant test values meet the following requirements:
  • White blood cell count ≥3×109/L or absolute value of neutrophile granulocyte ≥ 1.5×109/L,
  • Platelet count ≥ 100× 109/L,
  • AST and/or ALT\<2.5 times the upper limit of normal value,
  • Serum creatinine \< 2 times the upper limit of normal value,
  • Physical fitness score: Karnofsky(KPS) score ≥60, The Eastern Cooperative Oncology Group(ECOG) score is ≤2 points.

Age in the registry: 18 years to 85 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.