Rectal CancerNORWAITNCT03402477
"Watch and Wait" After Neo-adjuvant Chemoradiotherapy for Primary Locally Advanced Rectal Cancer.
An observational study of Rectal Cancer, run by Helse Stavanger HF at 7 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- How many people
- 86 participants
- Where
- 7 sitesNorway
- Study dates
- 10 Jan 2018to 19 Apr 2024
- 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: All patients in Norway with rectal cancer treated with neo-adjuvant radio-chemotherapy according to Norwegian national guidelines, who have complete clinical response at 6-12 weeks after fulfilled treatment
Who may be able to join
- Histologically verified adenocarcinoma of the rectum within 15 cm from the anal verge measured by rigid proctoscopy
- Patients who have completed neoadjuvant treatment according to national guidelines for rectal cancer, i.e., radiotherapy or chemo-radiotherapy (at least 40 Gy) or short-course radiotherapy combined with chemotherapy
- Patients aged ≥18 years of age are eligible for inclusion. However, patients aged ≤40 years are recommended to undergo surgery on the theoretical base of a possibly more aggressive tumour disease in this age group, and will be asked to participate in the study by consenting to recording of data. Those patients who insist on W\&W approach after careful consideration and well-documented informed consent are eligible for entering the W\&W protocol.
- Given informed consent
- Stage I-III rectal cancer; however, patients with limited liver metastases who undergo primary liver surgery as part of a "liver first" treatment approach may be included
Who cannot join
- Patients without cCR
- Patients unable to give informed consent
- Patients with short course radiotherapy (5x5 Gy) without additional chemotherapy, or patients receiving less than 40 Gy in long course CRT
- Patients with cCR but with increasing tumour growth on MRI after preoperative treatment
- Patients with metastatic disease at the time of diagnosis with the exception of those who are eligible for "liver first" treatment approach as part of an intention to cure approach.
- Patients previously diagnosed and treated for malignant disease in the pelvic region with radio- or chemoradiotherapy
- Other circumstances that may interfere with successful participation in the W\&W protocol
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Norway7 sites
Haukeland University Hospital
Bergen
Sørlandet Hospital Kristiansand
Kristiansand
Akershus University Hospital
Lørenskog, 1478
Oslo University Hospital
Oslo
Stavanger University Hospital
Stavanger
University Hospital Northern Norway
Tromsø
St. Olavs Hospital
Trondheim
About this study
Official title: "Watch and Wait" in Patients With Complete Clinical Response (cCR) After Neo-adjuvant Chemoradiotherapy for Primary Locally Advanced Rectal Cancer.
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
- Rectal Cancer
- Keywords
- locally advanced, neo-adjuvant treatment, Watch & Wait
- Medical subject headings
- Rectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of regrowth
rate of regrowth of tumor after initial complete clinical response (cCR) in patients who undergo a specially designed Watch \& Wait program and without surgical removal of the rectum; to determine the positive predictive value of cCR.
Measured: Baseline to 5 years
Secondary outcomes (7)
The rate of cCR after preoperative CRT
To calculate the rate of cCR in an national unselected cohort
Measured: Baseline to 5 years
Metachronous distant metastases in patients following the W&W protocol
To calculate the rate of the occurrence of distant metastases in patients who undergo the watch \& Wait program
Measured: Baseline to 5 years
Overall and cancer-specific survival protocol compared to patients with ypCR, i.e. patients with complete pathologic response after resection.
To analyse the overall and cancer-specific survival of patients with cCR following the W\&W
Measured: Baseline to 5 years
Patient-reported outcome measures - rectal function (LARS) and quality of life (QoL)
To evaluate the effect of the Watch and wait program on rectal function by using the Low anterior resection syndrome (LARS) score
Measured: Baseline to 5 years
Patient-reported outcome measures - quality of life (LARS) and quality of life (QoL)
To measure the effect of the Watch and wait program on quality of life by using the EORTC QLQ C30
Measured: Baseline to 5 years
Sensitivity, specificity and overall diagnostic accuracy of MRI with regard to the diagnosis of complete response
To compare the regression grade obtained by multi parametric MRI protocol to the clinical diagnose of complete response at baseline, i.e. clinical diagnosis of complete response
Measured: Baseline to 5 years
Diagnostic accuracy of MRI to detect regrowth during follow-up after complete response
To compare the accuracy of multi parametric MRI protocol with clinical examination during follow-up with regard to possible regrowth of the tumour
Measured: Baseline 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 posted18 Jan 2018
- Study start10 Jan 2018
- Primary completion19 Nov 2020
- Study completion19 Apr 2024
Why it stopped: Suspicion of adverse events
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- University Hospital of North Norway, St. Olavs Hospital, Helse-Bergen HF, Sorlandet Hospital HF, Oslo University Hospital, University Hospital, Akershus, Norwegian Institute of Public Health
- Responsible party
- Sponsor
- Investigators
- Hartwig Kørner, MD, PhD, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402477
- Sponsor's protocol ID
- SUSID674
- Acronym
- NORWAIT
- Status last verified
- Oct 2020
- First submitted
- 10 Jan 2018
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Watch and Wait" in Patients With Complete Clinical Response (cCR) After Neo-adjuvant Chemoradiotherapy for Primary Locally Advanced Rectal Cancer.
- ClinicalTrials.gov ID
- NCT03402477
- Acronym / sponsor ID
- NORWAIT / SUSID674
- Conditions
- Rectal Cancer
- Keywords
- locally advanced, neo-adjuvant treatment, Watch & Wait
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Suspicion of adverse events
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- University Hospital of North Norway, St. Olavs Hospital, Helse-Bergen HF, Sorlandet Hospital HF, Oslo University Hospital, University Hospital, Akershus, Norwegian Institute of Public Health
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 19 Nov 2020 (actual)
- Study completion
- 19 Apr 2024 (actual)
- First posted
- 18 Jan 2018 (actual)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients in Norway with rectal cancer treated with neo-adjuvant radio-chemotherapy according to Norwegian national guidelines, who have complete clinical response at 6-12 weeks after fulfilled treatment
Key inclusion criteria (5 listed)
- Histologically verified adenocarcinoma of the rectum within 15 cm from the anal verge measured by rigid proctoscopy
- Patients who have completed neoadjuvant treatment according to national guidelines for rectal cancer, i.e., radiotherapy or chemo-radiotherapy (at least 40 Gy) or short-course radiotherapy combined with chemotherapy
- Patients aged ≥18 years of age are eligible for inclusion. However, patients aged ≤40 years are recommended to undergo surgery on the theoretical base of a possibly more aggressive tumour disease in this age group, and will be asked to participate in the study by consenting to recording of data. Those patients who insist on W\&W approach after careful consideration and well-documented informed consent are eligible for entering the W\&W protocol.
- Given informed consent
- Stage I-III rectal cancer; however, patients with limited liver metastases who undergo primary liver surgery as part of a "liver first" treatment approach may be included
Key exclusion criteria (7 listed)
- Patients without cCR
- Patients unable to give informed consent
- Patients with short course radiotherapy (5x5 Gy) without additional chemotherapy, or patients receiving less than 40 Gy in long course CRT
- Patients with cCR but with increasing tumour growth on MRI after preoperative treatment
- Patients with metastatic disease at the time of diagnosis with the exception of those who are eligible for "liver first" treatment approach as part of an intention to cure approach.
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
Rate of regrowth
Time frame: Baseline to 5 years
rate of regrowth of tumor after initial complete clinical response (cCR) in patients who undergo a specially designed Watch \& Wait program and without surgical removal of the rectum; to determine the positive predictive value of cCR.
7 secondary outcomes
The rate of cCR after preoperative CRT
Time frame: Baseline to 5 years
Metachronous distant metastases in patients following the W&W protocol
Time frame: Baseline to 5 years
Overall and cancer-specific survival protocol compared to patients with ypCR, i.e. patients with complete pathologic response after resection.
Time frame: Baseline to 5 years
Patient-reported outcome measures - rectal function (LARS) and quality of life (QoL)
Time frame: Baseline to 5 years
Patient-reported outcome measures - quality of life (LARS) and quality of life (QoL)
Time frame: Baseline to 5 years
Sensitivity, specificity and overall diagnostic accuracy of MRI with regard to the diagnosis of complete response
Time frame: Baseline to 5 years
Diagnostic accuracy of MRI to detect regrowth during follow-up after complete response
Time frame: Baseline to 5 years
Results and safety
The study was stopped early (reason given: Suspicion of adverse events). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Hartwig Kørner, MD, PhD principal investigator
Helse Stavanger HF
7 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 Helse Stavanger HF at 7 sites in Norway.
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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Norway. 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 was stopped early (reason given: Suspicion of adverse events). Results are not available in the source record.
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?
Rate of regrowth (time frame: Baseline to 5 years). 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 24 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.