Clinical trial · Interventional
The Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma
A Multicenter, Prospective, Randomized Trial of the Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma
NCT01820858CI-TRIAL-00075614EC-01active not recruitingPhase 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)
This randomized trial is studying the efficacy and safety of the chemotherapy compared with radiation therapy alone as adjuvant treatment after operation in Patients with high risk and Stage I endometrial carcinoma.
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 Neoplasms | Endometrial Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Paraplatin (Carboplatin Injection) | Drug | Carboplatin | ALIAS |
| Pelvic Radiation | Radiation | — | UNRESOLVED |
| Vaginal Brachytherapy 1 | Radiation | — | UNRESOLVED |
| Vaginal brachytherapy 2 | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Adjuvant Chemotherapy
- description
- Paclitaxel: 175 mg/m(2) intravenously (IV); followed by Paraplatin (Carboplatin Injection) AUC=5 IV. 3-6 cycles as necessary.
- interventionNames
- Drug: Paclitaxel
- Drug: Paraplatin (Carboplatin Injection)
- type
- ACTIVE_COMPARATOR
- label
- Adjuvant Radiotherapy
- description
- 1. Histopathological grade G3 and \<50% myometrial invasion: Vaginal brachytherapy 5Gy, 3 times; 2. Histopathological grade G3 and vascular space involvement: Pelvic radiation 45-50 Gy; 3. ≥50% myometrial invasion: Pelvic radiation 50 Gy + Vaginal brachytherapy 5Gy, 2-4 times.
- interventionNames
- Radiation: Pelvic Radiation
- Radiation: Vaginal Brachytherapy 1
- Radiation: Vaginal brachytherapy 2
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * FIGO stage: Ⅰ, endometrial carcinoma; * Female, Chinese women; * Initial treatment is staging surgery; * Pathological diagnosis: Endometrial adenocarcinoma; * Pathologic examination and meet the following one of the indications of adjuvant therapy: ① histopathological grading in poorly differentiated: G3; ② ≥50% myometrial invasion; ③ vascular space involvement; * No prior treatment; * Provide written informed consent. Exclusion Criteria: * Unable to receive surgery and/or unsuitable for radiotherapy or chemotherapy; * Family history of ovarian cancer; * Suffering from other malignancies; * Concurrently participating in other clinical trials; * Unable or unwilling to sign informed consents; * Unable or unwilling to abide by protocol.
References
Publications (0)
Data not yet available
No reference posted for this study.