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"Watch and Wait" After Neo-adjuvant Chemoradiotherapy for Primary Locally Advanced Rectal Cancer.

NCT03402477 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 86

Last updated 2024-04-24

No results posted yet for this study

Summary

Among patients treated for locally advanced rectal cancer with neo-adjuvant radio-chemotherapy, about 15% will have complete clinical response in terms of no visible tumor or ulcerations on the site of the primary tumor, or whitening of the rectal wall or telangiectasia. In this Norwegian national multicenter observational study, patients with complete clinical response (cCR) after neo-adjuvant treatment for rectal cancer as defined by national guidelines, will be invited to a Watch\&Wait program with a specially designed follow-up in order to see if the tumor has disappeared permanently, or if there is regrowth of the tumor. Primary endpoint is the true regrowth rate in an unselected national cohort of patients.

Conditions

Sponsors & Collaborators

  • University Hospital of North Norway

    collaborator OTHER

  • St. Olavs Hospital

    collaborator OTHER

  • Helse-Bergen HF

    collaborator OTHER

  • Sorlandet Hospital HF

    collaborator OTHER_GOV

  • Oslo University Hospital

    collaborator OTHER

  • University Hospital, Akershus

    collaborator OTHER

  • Norwegian Institute of Public Health

    collaborator OTHER_GOV

  • Helse Stavanger HF

    lead OTHER_GOV

Principal Investigators

  • Hartwig Kørner, MD, PhD · Helse Stavanger HF

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-10
Primary Completion
2020-11-19
Completion
2024-04-19

Countries

  • Norway

Study Locations

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Entities

Diseases

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 NCT03402477 on ClinicalTrials.gov