Selective Targeting of Adjuvant Therapy for Endometrial Cancer (STATEC)

NCT02566811 | Terminated DMC

• 1 other identifier: UCL/13/0630
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this trial is to determine whether lymphadenectomy, used to restrict adjuvant therapy (other than vaginal brachytherapy) to node positive women, results in a non-inferior survival as compared to adjuvant therapy given to all women with high risk apparent stage 1 endometrial cancer.

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival

  5 years

Secondary Outcomes (6)

• Disease-free survival

  5 years

• Endometrial cancer-event free survival

  5 years

• Endometrial cancer-specific survival

  5 years

• Pelvic and extra-pelvic relapse-free survival

  5 years

• Cost effectiveness

  5 years

Other Outcomes (2)

• Quality of life- Patient Reported Outcomes

  5 years

• Accuracy, sensitivity and specificity (i.e. diagnostic performance) of sentinel lymph node (SLN) assessment, and the ratio of sensitivity to false positive rate (called likelihood ratio)

  5 years

Study Arms (2)

Abdominal surgery with lymphadenectomy

EXPERIMENTAL

Patients will receive a hysterectomy and bilateral salpingo-oophorectomy (BSO)\* with lymph node dissection to determine whether lymph nodes are positive or negative: Positive: patients will receive systemic adjuvant treatment to include chemotherapy Negative: patients will receive vaginal brachytherapy only Patients will then be followed up, to include assessment of adverse events and quality of life. \*There is an option for patients to be randomised following a pre-trial hysterectomy and BSO. If randomised to this arm, the lymph node dissection will be performed as a separate procedure.

Procedure: Abdominal surgery; Procedure: Lymphadenectomy

Abdominal surgery, no lymphadenectomy

ACTIVE COMPARATOR

Patients will receive a hysterectomy and bilateral salpingo-oophorectomy (BSO)\*. Patients will receive systemic adjuvant treatment to include chemotherapy. Patients will then be followed up, to include assessment of adverse events and quality of life. \*There is an option for patients to be randomised following a pre-trial hysterectomy and BSO. If randomised to this arm, no further surgery will be given and the patient will proceed to receive systemic adjuvant treatment to include chemotherapy.

Procedure: Abdominal surgery

Interventions

Abdominal surgery PROCEDURE

Hysterectomy defined as an extrafascial hysterectomy whereby the cervix is removed completely but no radical dissection of the parametria is required

Abdominal surgery with lymphadenectomy; Abdominal surgery, no lymphadenectomy

Lymphadenectomy PROCEDURE

Bilateral pelvic and para-aortic lymph node dissection

Abdominal surgery with lymphadenectomy

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• FIGO grade 3 endometrioid or mucinous carcinoma
• 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

You may not qualify if:

• 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:
• carcinoma in situ of cervix
• non-melanoma skin cancer
• basal cell carcinoma
• melanoma in situ
• Women who are pregnant or lactating

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College Hospital

London, Greater London, United Kingdom

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Lymph Node Excision

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Tim Mould

  University College London Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: October 2, 2015
• Study Start: April 12, 2017
• Primary Completion: August 14, 2019
• Study Completion: August 14, 2019
• Last Updated: September 30, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)