Rectal CancerNCT00952926
Watchful Waiting. An Observational Study of Patients With Rectal Cancer After Concomitant Radiation and Chemotherapy
An observational study of Rectal Cancer, run by Vejle Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate if operation and permanent stoma can be omitted in patients with cancer in the lower part of the rectum. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- How many people
- 55 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2009to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 referred from surgical departments in Denmark.
Who may be able to join
- Histopathologically verified adenocarcinoma in the rectum
- Planned APR or ultra low resection
- Primary resectable T2 or T3 tumor
- Distance from anus to lower edge of tumor ≤ 6 cm
- Suited for curative intended radiation and chemotherapy
- Accept taking of biopsy and blood samples for translational research
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- Age ≥ 18 years
- Normal function of bone marrow
- leukocytes ≥ 3 x 10^9/l
- thrombocytes ≥ 100
- Normal liver function
- ALAT < 2.5 x upper normal value
- bilirubin < 2.5 x upper normal value
- Renal function
- Serum creatinin < 1.5 x upper normal value
- Written and orally informed consent
Who cannot join
- Other malignant disease within the last 5 years apart from basocellular skin cancer and carcinoma in situ cervicis uteri
- Distant metastases
- Pregnant or breast feeding patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Observational Study of Patients With Rectal Cancer After Concomitant Radiation and Chemotherapy
The purpose of this study is to investigate if operation and permanent stoma can be omitted in patients with cancer in the lower part of the rectum.
Read the detailed description
Patients entering this study are offered the possibility of avoiding an extensive operation and a permanent stoma.
Over the past 2 years Vejle Hospital examined patients with rectal cancer during their course of treatment and we have developed a method to predict complete response.
Patients in this study are treated with chemotherapy and external irradiation supplemented with an endorectal boost (2 fractions). At the start of treatment and weeks 2, 4, and 6 of the treatment course an endoscopy is performed to evaluate the response. The final evaluation is performed 6 weeks after end of treatment. Patients with complete remission are offered observation. Patients with residual tumor are advised to be operated.
Follow-up is performed every 2 months the first year and every 3 months the second year. 2 follow-up visits are planned for the third year. A yearly follow-up is scheduled for the fourth and fifth year.
- Conditions
- Rectal Cancer
- Keywords
- Watchful Waiting, Rectal cancer, Observation, Avoid operation
- Medical subject headings
- Rectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of local recurrence
Measured: 1 year
Secondary outcomes (3)
Frequency of cumulative local recurrence
Measured: Up to 5 years
Frequency of distant metastases verified by planned PET/CT scans
Measured: Up to 5 years.
Overall survival
Measured: Up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startOct 2009
- Primary completionJan 2014
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anders Jakobsen, DMSc, Principal investigator, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952926
- Sponsor's protocol ID
- WW
- Status last verified
- Jan 2019
- First submitted
- 3 Aug 2009
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Appelt AL, Ploen J, Harling H, Jensen FS, Jensen LH, Jorgensen JC, Lindebjerg J, Rafaelsen SR, Jakobsen A. High-dose chemoradiotherapy and watchful waiting for distal rectal cancer: a prospective observational study. Lancet Oncol. 2015 Aug;16(8):919-27. doi: 10.1016/S1470-2045(15)00120-5. Epub 2015 Jul 5.
PubMed 26156652
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Patients With Rectal Cancer After Concomitant Radiation and Chemotherapy
- ClinicalTrials.gov ID
- NCT00952926
- Acronym / sponsor ID
- WW
- Conditions
- Rectal Cancer
- Keywords
- Watchful Waiting, Rectal cancer, Observation, Avoid operation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- Oct 2009 (actual)
- Primary completion
- Jan 2014 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 6 Aug 2009 (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 purpose of this study is to investigate if operation and permanent stoma can be omitted in patients with cancer in the lower part of the rectum.
Detailed description
Patients entering this study are offered the possibility of avoiding an extensive operation and a permanent stoma.
Over the past 2 years Vejle Hospital examined patients with rectal cancer during their course of treatment and we have developed a method to predict complete response.
Patients in this study are treated with chemotherapy and external irradiation supplemented with an endorectal boost (2 fractions). At the start of treatment and weeks 2, 4, and 6 of the treatment course an endoscopy is performed to evaluate the response. The final evaluation is performed 6 weeks after end of treatment. Patients with complete remission are offered observation. Patients with residual tumor are advised to be operated.
Follow-up is performed every 2 months the first year and every 3 months the second year. 2 follow-up visits are planned for the third year. A yearly follow-up is scheduled for the fourth and fifth year.
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 referred from surgical departments in Denmark.
Key inclusion criteria (16 listed)
- Histopathologically verified adenocarcinoma in the rectum
- Planned APR or ultra low resection
- Primary resectable T2 or T3 tumor
- Distance from anus to lower edge of tumor ≤ 6 cm
- Suited for curative intended radiation and chemotherapy
Key exclusion criteria (3 listed)
- Other malignant disease within the last 5 years apart from basocellular skin cancer and carcinoma in situ cervicis uteri
- Distant metastases
- Pregnant or breast feeding patients
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
Frequency of local recurrence
Time frame: 1 year
3 secondary outcomes
Frequency of cumulative local recurrence
Time frame: Up to 5 years
Frequency of distant metastases verified by planned PET/CT scans
Time frame: Up to 5 years.
Overall survival
Time frame: Up to 5 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Derived from this study: PubMed 26156652Appelt AL, Ploen J, Harling H, Jensen FS, Jensen LH, Jorgensen JC, Lindebjerg J, Rafaelsen SR, Jakobsen A. High-dose chemoradiotherapy and watchful waiting for distal rectal cancer: a prospective observational study. Lancet Oncol. 2015 Aug;16(8):919-27. doi: 10.1016/S1470-2045(15)00120-5. Epub 2015 Jul 5.
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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 principal investigator
Vejle Hospital
1 site 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 1 site 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 16 inclusion and 3 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: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of local recurrence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00952926, which also lists 1 linked publication.
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 5 Feb 2020.