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Selective Targeting of Adjuvant Therapy for Endometrial Cancer (STATEC) (STATEC)

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ClinicalTrials.gov Identifier: NCT02566811
Recruitment Status : Recruiting
First Posted : October 2, 2015
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
University College, London

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.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Procedure: Abdominal surgery Procedure: Lymphadenectomy Not Applicable

Detailed Description:

Results from this trial have the potential to change practice whatever the results: either lymphadenectomy will become recommended practice if a non-inferior outcome is obtained; otherwise the procedure can be safely abandoned.

Secondary Objectives

  • Disease-free, endometrial cancer-event free and endometrial cancer-specific survival
  • Distribution of pelvic and extra-pelvic relapse
  • Cost effectiveness
  • Surgical adverse events

There are also two sub-studies:

  1. Quality of life - all patients i. Describe the trajectory of key patient reported outcomes (PROs) from baseline up to 5 years post-surgery ii. Compare the specific PRO domains between the trial arms at several specific time points iii. Determine the proportion of women in each trial arm reporting long-term symptoms after treatment as measured by the symptom-specific subscales of the measures (gastrointestinal symptoms, urological symptoms, attitude to disease and treatment, vaginal symptoms, lymphoedema) iv. Determine the correlation between physician rating (CTCAE v4.03) and patient-report (corresponding PRO subscale) for various symptoms reported by both physicians and patients v. Assess the correlation between self-assessed lymphoedema (Self-report lower-extremity lymphoedema screening questionnaire) and the lymphoedema subscale of the Quality of Life Questionnaire-Endometrial Cancer Module (QLQ-EN24)

    We hypothesise that quality of life will be better in patients in the lymphadenectomy arm because a considerable proportion will be spared systemic adjuvant treatment, from which they may not benefit.

  2. Sentinel lymph node (SLN) - optional for Arm 1 patients

The aim of this sub-study is to assess SLN status in comparison with the overall lymph node status after full lymph node dissection (LND), and so determine whether SLN is as accurate as systematic node dissection.

i. We aim to determine the diagnostic performance of the SLN procedure compared to the gold standard of LND ii. To evaluate whether SLN status is a prognostic marker of survival iii. To model patient relapse and survival based on low volume micro-metastatic (LVM) and individual tumour cell (ITC) status


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Trial of Non-selective Versus Selective Adjuvant Therapy in High Risk Apparent Stage 1 Endometrial Cancer
Actual Study Start Date : April 12, 2017
Estimated Primary Completion Date : April 12, 2026
Estimated Study Completion Date : April 12, 2026

Arm Intervention/treatment
Experimental: Abdominal surgery with lymphadenectomy

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

Procedure: Lymphadenectomy
Bilateral pelvic and para-aortic lymph node dissection

Active Comparator: Abdominal surgery, no lymphadenectomy

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




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: 5 years ]
  2. Endometrial cancer-event free survival [ Time Frame: 5 years ]
  3. Endometrial cancer-specific survival [ Time Frame: 5 years ]
  4. Pelvic and extra-pelvic relapse-free survival [ Time Frame: 5 years ]
  5. Cost effectiveness [ Time Frame: 5 years ]
  6. Surgical adverse events [ Time Frame: 5 years ]

Other Outcome Measures:
  1. Quality of life [ Time Frame: 5 years ]
  2. 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) [ Time Frame: 5 years ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:

    1. FIGO grade 3 endometrioid or mucinous carcinoma
    2. 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:

    1. carcinoma in situ of cervix
    2. non-melanoma skin cancer
    3. basal cell carcinoma
    4. melanoma in situ
  • Women who are pregnant or lactating

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02566811


Contacts
Contact: Lee Webber +44 (0)20 7679 9872 ctc.STATEC@ucl.ac.uk
Contact: Mandy Feeney +44 (0)20 7679 9890 ctc.STATEC@ucl.ac.uk

Locations
United Kingdom
University College Hospital Recruiting
London, Greater London, United Kingdom
Contact: Dhara Bakhai         
Principal Investigator: Tim Mould         
Sponsors and Collaborators
University College, London
Investigators
Principal Investigator: Tim Mould University College London Hospital

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02566811     History of Changes
Other Study ID Numbers: UCL/13/0630
First Posted: October 2, 2015    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female