A randomised trial of nonselective versus selective adjuvant therapy in high risk apparent stage 1 endometrial cancer.

Phase 3

• Conditions: endometrial cancer; Cancer - Womb (Uterine or endometrial cancer)

• Registration Number: ACTRN12617000714381
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-17
• Last Update Posted: 10 February 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

* Histologically confirmed high risk apparent International Federation of Gynecology and Obstetrics (FIGO) stage I endometrial cancer according to one of the following criteria. Confirmation must be based on either diagnostic endometrial sampling or hysterectomy and BSO specimen if randomisation occurring after hysterectomy and BSO:
a.FIGO grade 3 endometrioid or mucinous carcinoma
b.High grade serous, clear cell, undifferentiated or dedifferentiated carcinoma or mixed cell adenocarcinoma or carcinosarcoma

* Surgery to be performed <= 5 weeks after randomisation in patients randomised prior to hysterectomy and BSO. Patients randomised after hysterectomy and BSO must have undergone hysterectomy and BSO <= 28 days prior to randomisation. Patients randomised after hysterectomy and BSO who are allocated lymphadenectomy must undergo lymphadenectomy <= 5 weeks after randomisation

* Written informed consent

* No prior anticancer therapy for endometrial cancer

* Eastern Cooperative Oncology Group (EGOC) performance status 0-2

* Life expectancy > 3 months

* Age >= 16 years

* Adequate organ and bone marrow function

* Ability to undergo post-operative chemotherapy with or without radiotherapy

* Adjuvant treatment to commence <= 8 weeks after surgery

* Willingness and ability to complete Quality of Life questionnaires

Exclusion Criteria

* Grossly enlarged node(s) of >= 10 mm short axis on baseline radiological imaging

* Invasion of the cervical stroma on baseline radiological imaging or obvious cervical disease on clinical examination

* Involvement of uterine serosa or metastatic disease seen outside the uterus on baseline radiological imaging

* Small cell carcinoma with neuroendocrine differentiation

* Concurrent anti-cancer therapy

* Previous malignancy < 5 years prior to randomisation or concurrent malignant disease with the exception of:
a.carcinoma in situ of cervix
b.non-melanoma skin cancer
c.basal cell carcinoma
d.melanoma in situ

* Women who are pregnant or lactating

Study & Design

• Study Type: Interventional
• Study Design: Not specified