Observational Study on Rectal Cancer to Verify if Response After Chemo-radiotherapy Can be Predicted With a Particular Blood Test.

NCT03699410 | Terminated

• 1 other identifier: ORL-CHIR-002
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

Research project for patients with locally advanced rectal cancer in which biological material and health-related personal data are collected. The aim is to investigate if an additional method (liquid biopsies) can predict the response after chemo-radiotherapy and before surgery.

Conditions

Locally Advanced Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Negative Prognostic Value (NPV)

  NPV of the liquid biopsy of ctDNA drawn from the mesenteric and peripheral blood

  day of surgery

Interventions

Neoadjuvant radiotherapy RADIATION

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 DRUG

Oral Capecitabine, at the standard dose of 825 mg/m2 twice daily, concomitant to radiotherapy.

Radical surgery PROCEDURE

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with locally advanced rectal cancer afferent to participating sites

You may qualify if:

• Age ≥ 18 years old
• 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

You may not qualify if:

• Presence of metastases
• 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

Sponsors & Collaborators

• Dimitri Christoforidis: lead
• Clinical Trial Unit Ente Ospedaliero Cantonale: collaborator

Study Sites (2)

Regional Hospital of Lugano

Lugano, 6900, Switzerland

Location

Clinica Luganese Moncucco

Lugano, 6903, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue: the biopsy at the time of diagnosis will be characterized using next-generation sequencing (NGS). Blood: circulating tumor DNAs (ctDNAs) from plasma collected at diagnosis and at various time-points in the patients' treatment.

MeSH Terms

Interventions

Neoadjuvant Therapy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• Dimitri Christoforidis

  Surgery and Visceral Surgery Departments Regional Hospital of Lugano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief of the Surgery and Visceral Surgery Departments

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 9, 2018
• Study Start: August 28, 2018
• Primary Completion: October 20, 2020
• Study Completion: October 20, 2020
• Last Updated: October 13, 2021

Record last verified: 2021-10

Locations

CH (2)