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

• Status: Not yet recruiting
• Trial end date: 2030-08-20
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

• 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:

A. White blood cell count ≥3×109/L or absolute value of neutrophile granulocyte ≥ 1.5×109/L,

B. Platelet count ≥ 100× 109/L,

C. AST and/or ALT<2.5 times the upper limit of normal value,

D. Serum creatinine < 2 times the upper limit of normal value,

E. Physical fitness score: Karnofsky(KPS) score ≥60, The Eastern Cooperative Oncology Group(ECOG) score is ≤2 points.

Exclusion Criteria:

• 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.