Modality of Adjuvant Radiotherapy and Chemotherapy for Stage Ⅲ Endometrial Cancer

NCT ID: NCT04453904

Last Updated: 2020-07-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 654 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-12
• Study Completion Date: 2027-04-30

Brief Summary

Endometrial cancer is the most common gynecological malignancy affecting women's health. About 15% of the patients will have local late disease (stage III) with high risk of recurrence and tumor related mortality. There is a consensus that adjuvant radiochemotherapy is needed for stage Ⅲ endometrial cancer, but the best modality of radiochemotherapy is still uncertain. The retrospective data of our center showed that the sequential radiochemotherapy of "chemotherapy-radiotherapy-chemotherapy" in the "sanwich" mode could improve the survival outcome in patients with advanced endometrial cancer. A multicenter, prospective, randomized controlled study to compare the "sanwich" mode of radiochemotherapy and the "concurrent chemoradiotherapy followed by chemotherapy" mode will be carried out to determine the better modality of radiochemotherapy in stage III endometrial adenocarcinoma.

Conditions

Endometrial Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

sequential radiochemotherapy in a "sanwich" mode

Two courses of TC regimen chemotherapy (paclitaxel 135-175mg / m2; carboplatin AUC = 5; once every 21 days) will be given first, followed by external pelvic radiation (± vaginal brachytherapy), and then four courses of the same regime consolidation chemotherapy.

Group Type: EXPERIMENTAL

sequential radiochemotherapy in a "sanwich" mode

Intervention Type: OTHER

Patients will randomized into two different modalities of radiochemotherapy.

concurrent chemoradiotherapy followed by chemotherapy

External pelvic radiation (± vaginal brachytherapy) will be given after operation. On the first day and the 29th day of radiotherapy, concurrent intravenous cisplatin (50mg/m2) will be given. After the concurrent radiochemotherapy, four courses of TC regimen (paclitaxel 135-175mg / m2; carboplatin AUC = 5; once every 21 days) chemotherapy will be given.

Group Type: ACTIVE_COMPARATOR

sequential radiochemotherapy in a "sanwich" mode

Intervention Type: OTHER

Patients will randomized into two different modalities of radiochemotherapy.

Interventions

sequential radiochemotherapy in a "sanwich" mode

Patients will randomized into two different modalities of radiochemotherapy.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. patients of primary treatment

2. All patients must have undertaken comprehensive staging operation（Surgery must have included a hysterectomy and bilateral salpingooophorectomy and surgical staging).

3. Patients with endometrial adenocarcinoma confirmed by postoperative patholog.

4. All patients with Surgical Stage III endometrial carcinoma according to FIGO 2009 staging criteria.

5. Entry into the study is limited to no more than 8 weeks from the date of surgery.

6. Patients with adequate organ function, reflected by the following parameters:

1. WBC ≥ Normal value of the institution;

2. Absolute neutrophil count (ANC) ≥ Normal value of the institution;

3. Platelet count ≥ 100,000/mcl;

4. SGOT, SGPT, and alkaline phosphatase ≤ 1.25 X upper limit of normal (ULN) ;

5. Bilirubin ≤ 1.5 X ULN;

6. Creatinine ≤ institutional ULN.

7. Patients with a Karnofsky score≥60.

8. The patients should voluntarily join the study, sign an approved informed consent with good compliance and cooperation with the follow-up.

Exclusion Criteria

1. Patients who have received prior adjuvant therapy (radiotherapy or chemotherapy or endocrine therapy).

2. Patients with residual tumor after surgery.

3. Patients with other invasive malignancies.

4. Patients with contraindications of radiotherapy and chemotherapy (with a history of myocardial infarction within 3 month, unstable angina pectoris or history of uncontrolled arrhythmia s from the date of registration) and who cannot receive postoperative adjuvant radiotherapy and chemotherapy.

5. Patients with an estimated survival of less than 6 months.

6. Those who are unable or unwilling to comply with the research requirements

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jianliu Wang

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Guo Zhang, Ph.D

Role: CONTACT

zhangguo-2005@163.com

+861088324381

Facility Contacts

Jianliu Wang, Doctor

Role: primary

wangjianliu@pkuph.edu.cn

Other Identifiers

2020PHB013-01

Identifier Type: -

Identifier Source: org_study_id