The Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma (EC-01)

Ding Ma

Status and phase: Active, not recruiting; Phase 3

Conditions: Endometrial Neoplasms

Treatments: Radiation: Vaginal brachytherapy 2; Drug: Paraplatin (Carboplatin Injection); Radiation: Vaginal Brachytherapy 1; Drug: Paclitaxel; Radiation: Pelvic Radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT01820858

2012-GYN/EC-01

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Adjuvant Chemotherapy

Experimental group

Description:

Paclitaxel: 175 mg/m(2) intravenously (IV); followed by Paraplatin (Carboplatin Injection) AUC=5 IV. 3-6 cycles as necessary.

Treatment:

Drug: Paclitaxel

Drug: Paraplatin (Carboplatin Injection)

Adjuvant Radiotherapy

Active Comparator group

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.

Treatment:

Radiation: Vaginal brachytherapy 2

Radiation: Vaginal Brachytherapy 1

Radiation: Pelvic Radiation