Study to Determine the Feasibility of Sentinel Node Biopsy in Patients With Anal Cancer

Withdrawn

• Conditions: Squamous Cell Carcinoma of the Anus
• Interventions: Procedure: Sentinel lymph node biopsy

• Registration Number: NCT02162641
• Lead Sponsor: The Christie NHS Foundation Trust

Brief Summary

The purpose of this study is assess the technical and operational feasibility of a specialised biopsy technique, sentinel lymph node biopsy (SLNB), in patients with anal cancer.

Detailed Description

SLNB is based on the premise that lymphatic dissemination from a tumour occurs in a stepwise fashion, with initial involvement of a primary node, called the sentinel node, before dissemination to the remainder of the lymphatic chain. If the sentinel node is histologically negative, then the remainder of the nodes in the same anatomic region will be at a lower (assumed to be minimal) risk of containing metastases. SLNB is part of standard care for patients with malignant melanoma and with breast cancer but has yet to be prospectively evaluated in patients with anal cancer.

Currently, the standard way to treat patients with anal cancer is to deliver a combination of chemotherapy and radiation to the tumour at the anus together with 'preventative' (prophylactic) radiotherapy to the lymph glands of the groin and pelvis. There is a growing perception for the need to reduce the morbidity of radiotherapy i.e. current regimens over-treat the patient and one approach is to reduce radiotherapy volume and/or dose where there is an absence or very low risk of nodal metastases.

This feasibility study is a vital first step in informing the design of a larger study examining the role of SLNB in clinical decision-making and outcomes for patients with anal cancer. In this trial eligible patients will attend for lymphoscintigraphy, to locate the lymph node, before sentinel lymph node removal by surgery. Detection rate of the sentinel node(s) will be the key outcome for the study.

Study Timeline

• Study First Submitted: 2014-06-11
• Study First Submitted QC: 2014-06-12
• Study First Posted: 2014-06-13
• Study Start: 2014-09
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-02
• Last Update Posted: 2015-06-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients with squamous cell carcinoma (SCC) of the anus (any T size and/or those with recurrent disease)
• Equivocal lymph node involvement on standard CT staging or magnetic resonance (MR) staging or PET-CT scan, as determined by the anal cancer multidisciplinary team (MDT)
• Age >= 18 years
• Written informed consent provided by the patient

Read More

Exclusion Criteria

• Patients with unequivocal lymph node involvement on standard CT staging or MR staging, as determined by the anal cancer MDT.
• Unfit for surgical biopsy
• Patients undergoing palliative treatment
• Previous pelvic or inguinal area radiotherapy
• Other coincident cancers
• Previous inguinal surgery (e.g. hernia repair) with mesh insertion

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SCC of the anus	Sentinel lymph node biopsy	-

Primary Outcome Measures

Name	Time	Method
The proportion of nodes detected will be expressed per inguinal nodal basin and per number of patients	Day 0 (Day of SLNB)

Secondary Outcome Measures

Name	Time	Method
Micro-metastatic disease within sentinel nodes	Days 7 to 10
Surgical complications	Up to 15 weeks after SLNB	To include wound healing assessment and assessment of pain
Delays in receiving radiotherapy treatment	15 weeks after SLNB	Any delay greater than 37 days from presentation to treatment