NCT02438839

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Sep 2015Dec 2026

First Submitted

Initial submission to the registry

May 5, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2022

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

6.5 years

First QC Date

May 5, 2015

Last Update Submit

January 6, 2026

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with locoregional tumor control with chemoradiation alone two years after end of treatment

    2 years after end of treatment

Secondary Outcomes (3)

  • Cumulative incidence of local recurrence after surgery

    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

    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

    6 and potentially 12 weeks after end of treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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
  • +2 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Department of Oncology, Aalborg University Hospital

Aalborg, Denmark

Location

Department of Surgery, Aalborg University Hospital

Aalborg, Denmark

Location

Department of Oncology, Rigshospitalet

Copenhagen, Denmark

Location

Department of Oncology, Vejle Hospital

Vejle, Denmark

Location

Department of Surgery, Vejle Hospital

Vejle, Denmark

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Anders Jakobsen, DMSc

    Department of Oncology, Vejle Hospital

    STUDY CHAIR

  • Henrik Jensen, PhD

    Department of Oncology, Vejle Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2015

First Posted

May 8, 2015

Study Start

September 1, 2015

Primary Completion

March 17, 2022

Study Completion (Estimated)

December 1, 2026

Last Updated

January 8, 2026

Record last verified: 2026-01

Locations

DK(5)