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

NCT03699410 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2021-10-13

No results posted yet for this study

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

Interventions

RADIATION

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.

DRUG

Neoadjuvant chemotherapy

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

PROCEDURE

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.

Sponsors & Collaborators

  • Clinical Trial Unit Ente Ospedaliero Cantonale

    collaborator OTHER

  • Dimitri Christoforidis

    lead OTHER

Principal Investigators

  • Dimitri Christoforidis · Surgery and Visceral Surgery Departments Regional Hospital of Lugano

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-28
Primary Completion
2020-10-20
Completion
2020-10-20

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03699410 on ClinicalTrials.gov