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

Overview

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.

Full Title of Study: “R-SeNSAR Feasibility Study: The Role of Sentinel Node Biopsy in Patients With Anal Cancer”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2015

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.

Interventions

  • Procedure: Sentinel lymph node biopsy

Arms, Groups and Cohorts

  • SCC of the anus

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Christie NHS Foundation Trust
  • Provider of Information About this Clinical Study
    • Principal Investigator: Emmie Taylor, Clinical Trials Project Manager – The Christie NHS Foundation Trust
  • Overall Official(s)
    • Andrew G Renehan, Study Chair, The Christie NHS Foundation Trust

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