The EXCISE Study - EXcisional treatment Comparison for In Situ Endocervical adenocarinoma

Phase 2

Completed

• Conditions: Adenocarcinoma in situ (AIS) of the uterine cervix; Cancer - Cervical (cervix)

• Registration Number: ACTRN12617000132347
• Lead Sponsor: St John of God Hospital, Subiaco WA 6008

Brief Summary

Our findings suggest that LEEP may be a safe alternative to CKC when performed in a tertiary dysplasia or gynecologic oncology center. LEEP was associated with fewer post-operative complications. A definitive phase 3 randomized non-inferiority trial to compare margin status and rates of treatment failure after LEEP and CKC is warranted. However, given the slow accrual in the current study, and the required sample size to demonstrate non-inferiority of LEEP, a phase 3 trial would not be feasible in Australia and New Zealand and would require international collaboration.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-24
• Study Completion: 2019-10-25
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1. Aged between > = 18 to < = 45 years of age at time of study enrolment.
2. Documentation of AIS on cervical cytology and/or cervical biopsy test results.
3. Lesion amendable to single pass excision (serial endocervical excisions including 'top-
hat' will not be permitted in accordance with American Society for Colposcopy and
Cervical Pathology Recommendations.
4. Proficient in English

Exclusion Criteria

1. High-grade cervical abnormality prior to current AIS diagnosis.
2. Previous excisional or ablative treatment (LEEP, CKC, Fisher cone biopsy, laser cone).
3. Cytology suspicious of invasion.
4. Clinical/colposcopic suspicion of invasion.
5. Presence of a concurrent gynaecological cancer.
6. Patients unable to comply with follow-up evaluations.
7. Immunosuppression.
8. Pregnancy.
9. Lesion considered unsuitable for single pass excision by treating specialist.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AIS histopathological margin status - either margins involved (positive margin) or margins not involved (negative margin)<br><br>Rationale: margin status has consistently been shown to predict persistence and recurrence of cervical AIS. Disruption to the excision specimen can make orientation and interpretation of tissue margins impossible. If there are significantly more LEEP specimens with positive margins compared to those excised by CKC, or if there are a greater number of specimens excised in more than one piece compared to CKC, then it may not be appropriate to conduct a larger phase III study.[Baseline (at the time of the procedure).];Status of the excised specimen (single specimen or more than one piece).[Baseline (at the time of the procedure).]

Secondary Outcome Measures

Name	Time	Method
Frequency of post-operative infection assessed by review of the medical records.<br><br>Rationale: retrospective studies suggested that LEEP is associated with fewer early complications. Although the proposed study is underpowered to detect differences in these outcomes, the purpose of their inclusion is to determine the feasibility of data collection.[6 weeks post procedure];Frequency of secondary haemorrhage assesses by review of medical records.[6 weeks post procedure];Hospital readmission assessed by review of medical records.[6 weeks post procedure];Return to the operating theatre assessed by review of medical records.[6 weeks post procedure];Patient satisfaction assessed by using those aspects of the European Organization for Research and Treatment of Cancer in-patient satisfaction EORTC-OUTPATSAT-7 and EORTC-PATSAT-33 which will provide data in line with Section 7 and Section 12.<br>of the protocol. [6 weeks post procedure]