Rectal CancerWW2NCT02438839
Curative Chemoradiation of Low Rectal Cancer
An observational study of Rectal Cancer, run by Vejle Hospital at 5 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- How many people
- 108 participants
- Where
- 5 sitesDenmark
- Study dates
- Sep 2015to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Department of Oncology, Aalborg University Hospital
Aalborg
Department of Surgery, Aalborg University Hospital
Aalborg
Department of Oncology, Rigshospitalet
Copenhagen
Department of Oncology, Vejle Hospital
Vejle
Department of Surgery, Vejle Hospital
Vejle
About this study
Official title: 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.
- Conditions
- Rectal Cancer
- Medical subject headings
- Rectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with locoregional tumor control with chemoradiation alone two years after end of treatment
Measured: 2 years after end of treatment
Secondary outcomes (3)
Cumulative incidence of local recurrence after surgery
Measured: 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
Measured: 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
Measured: 6 and potentially 12 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startSep 2015
- Primary completion17 Mar 2022
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anders Jakobsen, DMSc, Study chair, Department of Oncology, Vejle HospitalHenrik Jensen, PhD, Principal investigator, Department of Oncology, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438839
- Sponsor's protocol ID
- WW2
- Acronym
- WW2
- Status last verified
- Jan 2026
- First submitted
- 5 May 2015
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curative Chemoradiation of Low Rectal Cancer. A Prospective Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT02438839
- Acronym / sponsor ID
- WW2 / WW2
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- 17 Mar 2022 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients with locoregional tumor control with chemoradiation alone two years after end of treatment
Time frame: 2 years after end of treatment
3 secondary outcomes
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Jakobsen, DMSc study chair
Department of Oncology, Vejle Hospital
Henrik Jensen, PhD principal investigator
Department of Oncology, Vejle Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Vejle Hospital at 5 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with locoregional tumor control with chemoradiation alone two years after end of treatment (time frame: 2 years after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.