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


Phase 3
18 Years
65 Years
Open (Enrolling)
Female
Endometrial Neoplasms

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival (DFS)

Outcome Time Frame:

3-year DFS

Safety Issue:

No

Principal Investigator

Beihua Kong, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Qilu Hospital, Shandong University

Authority:

China: Ministry of Health

Study ID:

2012-GYN/EC-01

NCT ID:

NCT01820858

Start Date:

November 2012

Completion Date:

Related Keywords:

  • Endometrial Neoplasms
  • Neoplasms
  • Carcinoma
  • Endometrial Neoplasms
  • Adenoma

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