Clinical trial · Interventional
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
NCT05489848CI-TRIAL-00060153not yet recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Aim to compare chemotherapy alone or chemoradiotherapy for post-operative endometrial cancer (stage I-IVA) with p53 mutation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| EBRT | Radiation | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| VBT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm1: Chemotherapy group
- description
- Paclitaxel plus carboplatin (TC) regimen, intravenous chemotherapy. Once every three weeks with total of 6 cycles.
- interventionNames
- Drug: Paclitaxel
- Drug: Carboplatin
- type
- ACTIVE_COMPARATOR
- label
- Arm2: Radiotherapy plus chemotherapy group
- description
- Stage IA: TC(Paclitaxel plus carboplatin) regimen for 4 course+/-VBT. Stage IB-II ( with no residual disease): TC regimen for 2 course +EBRT (external irradiation radiotherapy) plus cisplatin concurrent chemotherapy +TC regimen for 2 course ±VBT. Stage III-IVA ( with no residual disease) and any stage except IVB (residual disease \<2cm): TC regimen for 2 course +EBRT (external irradiation radiotherapy) plus cisplatin concurrent chemotherapy +TC regimen for 2 course ±VBT. Radiotherapy can be started 3 weeks after the completion of the chemotherapy, and Chemotherapy can be started 2 - 3 weeks after the completion of radiotherapy.
- interventionNames
- Drug: Paclitaxel
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.