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

Squamous Cell Carcinoma of the Anus Clinical Trial

— R-SeNSAR  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02162641
• Other study ID #: 13_DOG03_261
• Secondary ID: CFTSp081
• Status: Withdrawn
• Phase: N/A
• First received: June 11, 2014
• Last updated: June 2, 2015
• Start date: September 2014
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Christie Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anus Neoplasms
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma of the Anus

Intervention

Procedure:
• Sentinel lymph node biopsy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Christie Hospital NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of nodes detected will be expressed per inguinal nodal basin and per number of patients		Day 0 (Day of SLNB)	No
Secondary	Micro-metastatic disease within sentinel nodes		Days 7 to 10	No
Secondary	Surgical complications	To include wound healing assessment and assessment of pain	Up to 15 weeks after SLNB	No
Secondary	Delays in receiving radiotherapy treatment	Any delay greater than 37 days from presentation to treatment	15 weeks after SLNB	No