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

NCT01820858Active, Not RecruitingPHASE3INTERVENTIONAL

Summary

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.

Key Facts

Lead Sponsor

Ding Ma

Enrollment

300

Start Date

2012-11-01

Completion Date

2025-12-01

Study Type

INTERVENTIONAL

Official Title

A Multicenter, Prospective, Randomized Trial of the Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma

Interventions

PaclitaxelParaplatin (Carboplatin Injection)Pelvic RadiationVaginal Brachytherapy 1Vaginal brachytherapy 2

Conditions

Endometrial Neoplasms

Eligibility

Age Range

18 Years – 65 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Disease-free survival (DFS)

Time frame: 3-year DFS

Secondary Outcomes

Side effect of adjuvant chemotherapy

The incidence of infusion reactions (i.e.,skin reactions, cardiovascular reactions, respiratory or throat tightness), and allergic reactions (i.e., life-threatening anaphylaxis)

Time frame: 3-month，6-month，1-year and 3-year

Complications of radiotherapy

To observe the subtle effect on quality of life (e.g., diarrhea, bowel symptoms) and vaginal stenosis.

Time frame: 3-month，6-month，1-year and 3-year

Quality of Life

Time frame: 3-month，6-month，1-year and 3-year

Overall survival (OS)

Time frame: 3-year OS

Locations

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

Qilu Hospital，Shandong University, Jinan, China

Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, China

Linked Diseases

Endometrial Neoplasms

Endometrial Neoplasms — a type of gynecological cancer.

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