Curative Chemoradiation of Low Rectal Cancer (WW2)

May 19, 2023 updated by: Vejle Hospital

Curative Chemoradiation of Low Rectal Cancer. A Prospective Multicenter Observational Study

The aim of the present study is to investigate whether curative chemoradiation of low rectal cancer is feasible, safe and effective in a multicenter study with results comparable to those of single center studies.

Results from previous studies indicate that a considerable fraction of patients with low rectal cancer can be cured by a combination of radiation and chemotherapy alone and thus be spared from operation.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark
        • Department of Oncology, Aalborg University Hospital
      • Aalborg, Denmark
        • Department of Surgery, Aalborg University Hospital
      • Copenhagen, Denmark
        • Department of Oncology, Rigshospitalet
      • Vejle, Denmark
        • Department of Oncology, Vejle Hospital
      • Vejle, Denmark
        • Department of Surgery, Vejle Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with low rectal cancer (tumor located ≤ 6 cm from the anal verge) who are referred to the participating departments and who fulfill the inclusion criteria.

Description

Inclusion Criteria:

  • Histopathologically verified adenocarcinoma of the rectum
  • Planned abdominoperineal resection (APR) or ultralow resection
  • Primary, resectable T1-T3, N0 tumor. N1 nodal disease is acceptable, if the positive lymph nodes are localized to the mesorectum at the level of the tumor.
  • Distance from anal verge to lower edge of tumor ≤ 6 cm measured by rigid rectoscope
  • Performance status 0-2
  • Patient acceptance to collection of biopsies and blood samples for translational research
  • Age ≥ 18 years

  • Normal function of bone marrow as evaluated by

    • neutrophils ≥ 1.5 x 10^9/l
    • thrombocytes ≥ 100

  • Normal function of liver

    • alanine aminotransferase (ALAT) < 2.5 x upper limit of normal
    • bilirubin < 2.5 x upper limit of normal

  • Kidney function

    - Serum creatinine < 1.5 x upper limit of normal or measured glomerular filtration rate (GFR) > 30 ml/min

  • Fertile women must present a negative pregnancy test and use secure contraceptives during and 3 months after treatment.
  • Written and orally informed consent

Exclusion Criteria:

  • Previous surgical treatment of the present cancer, including transanal excision of tumor.
  • Other malignant disease within the past five years except basocellular skin cancer and carcinoma in situ cervicis uteri
  • Distant metastases verified by imaging or biopsy
  • Previous radiation treatment of the pelvis
  • Pregnant or breastfeeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with locoregional tumor control with chemoradiation alone two years after end of treatment
Time Frame: 2 years after end of treatment
2 years after end of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Cumulative incidence of local recurrence after surgery
Time Frame: Every two months the first year, every three months the second year, every six months the third year, and annually the fourth and fifth years
Every two months the first year, every three months the second year, every six months the third year, and annually the fourth and fifth years
Rate of distant metastases
Time Frame: Every two months the first year, every three months the second year, every six months the third year, and annually the fourth and fifth years
Every two months the first year, every three months the second year, every six months the third year, and annually the fourth and fifth years
Response and tumor control on MRI scans compared to clinical observations, including rectoscopic examination
Time Frame: 6 and potentially 12 weeks after end of treatment
6 and potentially 12 weeks after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vejle Hospital

Investigators

  • Study Chair: Anders Jakobsen, DMSc, Department of Oncology, Vejle Hospital
  • Principal Investigator: Henrik Jensen, PhD, Department of Oncology, Vejle Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

March 17, 2022

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

May 5, 2015

First Submitted That Met QC Criteria

May 5, 2015

First Posted (Estimate)

May 8, 2015

Study Record Updates

Last Update Posted (Actual)

May 22, 2023

Last Update Submitted That Met QC Criteria

May 19, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WW2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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