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Trial registered on ANZCTR


Registration number
ACTRN12618001433291
Ethics application status
Approved
Date submitted
22/08/2018
Date registered
27/08/2018
Date last updated
27/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Sentinel Lymph Node imaging using SPECT/CT imaging before and after treatment with chemoradiotherapy in patients with cancer of the oesophagus or gastro-oesophageal junction
Scientific title
Sentinel Lymph Node imaging with sequential SPECT/CT lymphoscintigraphy before and after neoadjuvant chemoradiotherapy in patients with cancer of the oesophagus or gastro-oesophageal junction
Secondary ID [1] 295881 0
NEOSENT1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oesophageal cancer 309346 0
Condition category
Condition code
Cancer 308211 308211 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients undergoing a well defined regimen of neoadjuvant radio-chemotherapy consisting of three cycles of intrevenously administered Cisplatin/Oxaliplatin-5-FU and external beam radiation therapy with a total dose of 40 Gy given in fractions. Patientents will undergo hybrid SPECT/CT lymphoscintigraphy by means of endoscopically guided intratumoral injection of radiocolloid (4 X 0.5 mL in total of 60 MBq 99mTc-nanocoll (GE Healthcare Srl., Milan, Italy)). Patients undergo this procedure the week prior to and once again immediatly following conclusion of neoadjuvant therapy.
Intervention code [1] 312212 0
Diagnosis / Prognosis
Comparator / control treatment
No Control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307182 0
Reproducibility of Sentinel Lymph Node detection by means of comparing Sentinel Lymph Stations (as defined in the Japanese Classification of oesophageal cancer 11th edition) in baseline SPECT/CT examination to follow-up examination.
Timepoint [1] 307182 0
Assessed after 10 patients have been imaged.
Secondary outcome [1] 351021 0
None
Timepoint [1] 351021 0
None

Eligibility
Key inclusion criteria
Patients eligible for inclusion had to have histologically verified, clinical stage T2-T3, any N-stage, M0 cancer of the oesophagus or GE-junction planned for esophagectomy following neoadjuvant chemo radiotherapy. Patient age less than or equal to 75 years, physical performance status allowing esophagectomy and with a performance status, renal and haematological status permitting chemotherapy.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Poor performance, renal and hematoloical status.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 20795 0
Sweden
State/province [1] 20795 0
Stockholm

Funding & Sponsors
Funding source category [1] 300478 0
Hospital
Name [1] 300478 0
Karolinska University Hospital
Address [1] 300478 0
Karolinska University Hospital, Huddinge
SE-141 86 Stockholm
Country [1] 300478 0
Sweden
Primary sponsor type
Hospital
Name
Karolinska University Hospital
Address
Karolinska University Hospital, Huddinge
SE-141 86 Stockholm
Country
Sweden
Secondary sponsor category [1] 299949 0
None
Name [1] 299949 0
Address [1] 299949 0
Country [1] 299949 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301280 0
Regionala Etiknämnden i Stockholm
Ethics committee address [1] 301280 0
Regionala etikprövningsnämnden i Stockholm
FE 289
171 77 STOCKHOLM
Ethics committee country [1] 301280 0
Sweden
Date submitted for ethics approval [1] 301280 0
Approval date [1] 301280 0
04/03/2013
Ethics approval number [1] 301280 0
2011/347-31

Summary
Brief summary
In patientents with oesophageal cancer or cancer of the gastro-oesophageal junction, Sentinel Lymph Node Biopsy (SLNB) has the potential to identify patients without lymph node metastases and thus improve the staging accuracy. The impact of neoadjuvant treatment on the lymphatic drainage of oesophageal cancers and subsequently the SLNB procedure in this tumour type has not been well studied. This study aims to evaluate changes in lymphatic drainage patterns of the tumour in patients with cancer of the oesophagus or gastro-oesophageal junction (GOJ) using Sentinel Lymph Node (SLN) hybrid SPECT/CT lymphoscintigraphy before and after neoadjuvant chemo-radiotherapy.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 86470 0
Dr Stefan Gabrielson
Address 86470 0
FO Medicinsk strålningsfysik & Nuklearmedicin

Karolinska Universitetssjukhuset Huddinge

C2:74, 14186, Stockholm
Country 86470 0
Sweden
Phone 86470 0
+46858584642
Fax 86470 0
Email 86470 0
stefan.gabrielson@ki.se
Contact person for public queries
Name 86471 0
Dr Stefan Gabrielson
Address 86471 0
FO Medicinsk strålningsfysik & Nuklearmedicin

Karolinska Universitetssjukhuset Huddinge

C2:74, 14186, Stockholm
Country 86471 0
Sweden
Phone 86471 0
+46858584642
Fax 86471 0
Email 86471 0
stefan.gabrielson@ki.se
Contact person for scientific queries
Name 86472 0
Dr Stefan Gabrielson
Address 86472 0
FO Medicinsk strålningsfysik & Nuklearmedicin

Karolinska Universitetssjukhuset Huddinge

C2:74, 14186, Stockholm
Country 86472 0
Sweden
Phone 86472 0
+46858584642
Fax 86472 0
Email 86472 0
stefan.gabrielson@ki.se

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary