Study to Determine the Feasibility of Sentinel Node Biopsy in Patients With Anal Cancer (R-SeNSAR)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Squamous Cell Carcinoma of the Anus
• Intervention / Treatment: Procedure: Sentinel lymph node biopsy

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 Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with squamous cell carcinoma (SCC) of the anus with clinically negative or equivocal nodal involvement; and for consideration of chemo-radiotherapy, local excision or salvage surgery treatment. The majority will be initial presentations, but patients with recurrent disease may also be considered.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SCC of the anus	Procedure: Sentinel lymph node biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: The Christie NHS Foundation Trust
• Investigators: Study Chair: Andrew G Renehan, The Christie NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: June 11, 2014
• First Submitted That Met QC Criteria: June 12, 2014
• First Posted (Estimate): June 13, 2014

Study Record Updates

• Last Update Posted (Estimate): June 3, 2015
• Last Update Submitted That Met QC Criteria: June 2, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Anus Diseases; Anus Neoplasms
• Other Study ID Numbers: 13_DOG03_261; CFTSp081 (Other Identifier: Sponsor)