Observational Study on Rectal Cancer to Verify if Response After Chemo-radiotherapy Can be Predicted With a Particular Blood Test.
NCT ID: NCT03699410
Last Updated: 2021-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
25 participants
OBSERVATIONAL
2018-08-28
2020-10-20
Brief Summary
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The aim is to investigate if an additional method (liquid biopsies) can predict the response after chemo-radiotherapy and before surgery.
Detailed Description
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Since clinical complete response has only partial concordance with pathological complete response, an additional method that helps identify those patients with a true complete response is needed to avoid unnecessary surgery and its associated potential complications..
The hypothesis underlying this study is that the quantitative and qualitative evaluation of circulating tumor DNA (ctDNA) of liquid biopsy, based on the amount of ctDNA or on the detection of specific gene alterations respectively, may be directly correlated to the clinical, histopathological and radiological response of the tumor to nCRT.
This study will not interfere with the patient's routine treatment pathway and there will be no deviation from the standard of care. The only additional study intervention will be the collection of blood samples at 6 different time points which can be combined with the regular blood examination performed during the treatment.
At the time of diagnosis, tumor staging and histopathology on tumor biopsy will be performed. Patients will receive standardized neoadjuvant therapy and will be operated after an observational period of 10 weeks. Peripheral blood sample will be collected at 6 time points: pre-nCRT, at the end of the nCRT, at 4th and 7th week post-CRT, on the day of the surgery (before surgical resection), on the post-operative day 5 (in hospital). Mesenteric blood sample will be collected intra-operatively on the day of the surgery. Tumor sampling will be performed during tumor staging, as standard of care, and on the resection specimen. A combined qualitative and quantitative approach for the molecular characterization of tissue and liquid biopsy using next-generation sequencing will be carried out.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Neoadjuvant radiotherapy
Radiotherapy with total dose of at least 50 Gy on the tumor (cT) and the involved nodes (cN+) and with standard fractionation (1.8 Gy/fraction), 5 days/week.
Neoadjuvant chemotherapy
Oral Capecitabine, at the standard dose of 825 mg/m2 twice daily, concomitant to radiotherapy.
Radical surgery
The time point of surgery is usually dependent on surgeon's and institutional habits and lies within 6 to 12 weeks after the end of nCRT. Surgeons participating in this study will be asked to operate patients on the 10th week after the end of nCRT.
Eligibility Criteria
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Inclusion Criteria
* Locally advanced rectal cancer (T3 or T4, and/or N+) requiring long course nCRT (as decided by the regional tumor board)
* Patient fit for surgery and treated with curative intent
* Willingness to complete all clinical and radiological examinations foreseen by the study
* Availability of tissue specimen for molecular characterization at baseline
* Written informed consent
Exclusion Criteria
* Insufficient material on the tissue biopsy to be left in archives of the Cantonal Institute of Pathology for further evaluations/analyses
* Insufficient amount of tumor cells in the tissue biopsy for the molecular characterization
* Inability to consent and follow the procedures of the study
* Women who are pregnant or breast feeding
18 Years
ALL
No
Sponsors
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Clinical Trial Unit Ente Ospedaliero Cantonale
OTHER
Dimitri Christoforidis
OTHER
Responsible Party
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Dimitri Christoforidis
Deputy Chief of the Surgery and Visceral Surgery Departments
Principal Investigators
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Dimitri Christoforidis
Role: PRINCIPAL_INVESTIGATOR
Surgery and Visceral Surgery Departments Regional Hospital of Lugano
Locations
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Regional Hospital of Lugano
Lugano, , Switzerland
Clinica Luganese Moncucco
Lugano, , Switzerland
Countries
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Other Identifiers
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ORL-CHIR-002
Identifier Type: -
Identifier Source: org_study_id