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

NCT ID: NCT02162641

Last Updated: 2015-06-03

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-05-31

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.

Conditions

Squamous Cell Carcinoma of the Anus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

SCC of the anus

Sentinel lymph node biopsy

Intervention Type: PROCEDURE

Interventions

Sentinel lymph node biopsy

Intervention Type: PROCEDURE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Christie NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Emmie Taylor

Clinical Trials Project Manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew G Renehan

Role: STUDY_CHAIR

The Christie NHS Foundation Trust

Other Identifiers

CFTSp081

Identifier Type: OTHER

Identifier Source: secondary_id

13_DOG03_261

Identifier Type: -

Identifier Source: org_study_id