Squamous Cell Carcinoma of the AnusR-SeNSARNCT02162641
Study to Determine the Feasibility of Sentinel Node Biopsy in Patients With Anal Cancer
An observational study of Squamous Cell Carcinoma of the Anus, run by The Christie NHS Foundation Trust.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Anus
- What is being tested?
- Sentinel lymph node biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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
- Being tested
- Sentinel lymph node biopsy
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel lymph node biopsyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| SCC of the anus | Not described Receives: Procedure: Sentinel lymph node biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of nodes detected will be expressed per inguinal nodal basin and per number of patients
Measured: Day 0 (Day of SLNB)
Secondary outcomes (3)
Micro-metastatic disease within sentinel nodes
Measured: Days 7 to 10
Surgical complications
To include wound healing assessment and assessment of pain
Measured: Up to 15 weeks after SLNB
Delays in receiving radiotherapy treatment
Any delay greater than 37 days from presentation to treatment
Measured: 15 weeks after SLNB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: The study was terminated early as it failed to recruit.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the AnusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emmie Taylor, The Christie NHS Foundation Trust
- Investigators
- Andrew G Renehan, Study chair, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162641
- Sponsor's protocol ID
- 13_DOG03_261
- Other IDs
- CFTSp081
- Acronym
- R-SeNSAR
- Status last verified
- Jun 2015
- First submitted
- 11 Jun 2014
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- R-SeNSAR Feasibility Study: The Role of Sentinel Node Biopsy in Patients With Anal Cancer
- ClinicalTrials.gov ID
- NCT02162641
- Acronym / sponsor ID
- R-SeNSAR / 13_DOG03_261
- Conditions
- Squamous Cell Carcinoma of the Anus
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study was terminated early as it failed to recruit.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 13 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCC of the anus | – | Procedure: Sentinel lymph node biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sentinel lymph node biopsy | Procedure or surgery | SCC of the anus |
Primary outcome
The proportion of nodes detected will be expressed per inguinal nodal basin and per number of patients
Time frame: Day 0 (Day of SLNB)
3 secondary outcomes
Micro-metastatic disease within sentinel nodes
Time frame: Days 7 to 10
Surgical complications
Time frame: Up to 15 weeks after SLNB
Delays in receiving radiotherapy treatment
Time frame: 15 weeks after SLNB
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew G Renehan study chair
The Christie NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Squamous Cell Carcinoma of the Anus, run by The Christie NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of nodes detected will be expressed per inguinal nodal basin and per number of patients (time frame: Day 0 (Day of SLNB)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.