Rectal NeoplasmsWoWNCT03125343
Watch and Wait as Treatment for Patients With Rectal Cancer
A study testing endoscopy, Surgery and MRI in people with Rectal Neoplasms, run by Sahlgrenska University Hospital at 2 sites in Sweden.
Trial summary
A national cohort study with all patients scheduled for neoadjuvant treatment with (chemo)radiotherapy or short course radiotherapy with delayed surgery 6-8 weeks) for rectal cancer staged as cT4bNX/anycTanycN and cMRF+/anycTanycN and lateral lymph nodes on MRI (and patients that have been offered short course… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- endoscopy, Surgery and MRI
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesSweden
- Study dates
- Jan 2017to Dec 2028
- Phase
- Interventional
- 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
Who may be able to join
- All patients in Sweden with a palpable rectal cancer staged as cT4bNX/anycTanycN and cMRF+/anycTanycN and lateral lymph nodes on MRI considered appropriate for 5x5 Gy and 6-8 weeks of wait prior to surgery according to Stockholm III (28) or a palpable rectal cancer staged as cT4bNX/anycTanycN and cMRF+/anycTanycN and lateral lymph nodes on MRI a planned schedule for CRT according to the Swedish National Program for rectal cancer scheduled for neoadjuvant therapy are possible to include.
- The study includes two parts, where part one is optional in including hospitals. The aim of the biopsy substudy to identify tumour and plasma markers for complete response, thus all patients that will receive (chemo)radiotherapy in the neoadjuvant setting are included to provide a control for the biopsies.
- For the WoW part of the study all patients that achieve complete response after neoadjuvant treatment according to the specified criteria above can be included in the Watch and Wait protocol. In detail this includes patients with:
- Midrectal or low rectal cancers that are palpable and considered with an indication of 5x5 Gy and long wait (6-8 weeks) (the indication for waiting may be logistics, co-morbidity, advanced age):
- cT4bNX
- anycTanycN and cMRF+ anycTanycN and lateral lymph nodes on MRI
Who cannot join
- No informed consent received for participation.
- Patients with rectal cancer that is scheduled for (chemo) radiotherapy but is not palpable during rectal examination (10-15 cm) as this cannot be examined by digital examination and followed as scheduled.
- Contraindication for MRI such as presence of non compatible metallic implants or claustrophobia.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Eva Angenete, M.D., Ph.D. contact
Sweden2 sites, 2 recruiting
- Recruiting
Dept. of Surgery, Sahlgrenska University Hospital/Ostra
Gothenburg, SE 416 85
Eva Angenete, MD,PhD, +46313438410, eva.angenete@vgregion.se
- Recruiting
Karolinska Institutet
Stockholm
Anna Martling, Professor
About this study
Official title: A Multicenter Prospective National Cohort Study for Patients With Advanced Rectal Cancer - is it Possible to Induce Remission and Avoid Surgery - Watch and Wait?
A national cohort study with all patients scheduled for neoadjuvant treatment with (chemo)radiotherapy or short course radiotherapy with delayed surgery 6-8 weeks) for rectal cancer staged as cT4bNX/anycTanycN and cMRF+/anycTanycN and lateral lymph nodes on MRI (and patients that have been offered short course raditotherapy with delayed surgery due to various reasons). The tumours are positioned midrectal or low and are palpable with the finger. The patients offered this treatment after recommendations on their local multidisciplinary tumour board will be will be informed and offered to participate in the study. Patients scheduled for short course radiotherapy with immediate surgery cannot be included.
Read the detailed description
- Biopsies and blood from patients with rectal cancer subject to neoadjuvant treatment with (chemo)radiotherapy or radiotherapy 5x5 Gy with at least 6-8 weeks wait until surgery. All patients will be asked to answer a QoL questionnaire (appendix C) to cover their experiences of the neaodajvuant treatment. (Answered at diagnosis and at evaluation of treatment and decision of surgery or inclusion in the Watch and Wait part of the study).
All patients will undergo scheduled (chemo)radiotherapy according to national guidelines. The patients with chemoradiotherapy will be evaluated at 8-10 weeks after completed treatment (25) with pelvic MRI. After this evaluation at 8-10 weeks patients with suspected complete response or near complete response will examined according to the protocol below.
All patients that are considered to have complete response will be offered a "Watch and wait" approach with follow-up according to the protocol. They will then be followed at one of the Regional University Hospitals within their catchment are.
All patients with a palpable rectal cancer staged as cT4bNX/anycTanycN and cMRF+/anycTanycN and lateral lymph nodes on MRI (and patients that have been offered short course raditotherapy with delayed surgery due to various reasons) that does not achieve complete response will serve as control and will be treated with surgery as planned prior to initiation of (chemo)radiotherapy.
Patients with indication of complete response on follow-up MRI will undergo endoscopy, and digital rectal examination to ascertain complete response. MRI together with documentation from endoscopy will be reviewed at the Regional University Hospital to extablish agreement regarding interpretation. All the below mentioned criteria must be fullfilled to be considered complete response:
- No suspicious metastatic lymph nodes or evidence of remaining tumour on MRI. In the majority of cases a complete response on MRI will be seen as areas of homogeneous fibrosis. Absence of any remaining pathological tissue is seen in a minority of cases.
- Endoscopic examination with light/white mucosa or scar, telangiectasies. Prescence of fibrosis and oedema.
- No palpable tumour on clinical examination (26).
In the spring of 2023 200 pts included. An amendment was sent to the ethical review board to enable continued inclusion while the initial 200 pts are analyzed. This has been approved and the study has thus planned continuation for another 2-3 years.
- Conditions
- Rectal Neoplasms
- Being tested
- endoscopy, Surgery, MRI
- Keywords
- radiotherapy, chemotherapy, complete response
- Medical subject headings
- Rectal Neoplasms, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopyProcedure or surgery
Continuous follow-up. All patients with complete response will be followed for ten years. Details from the follow-up schedule will be registered in clinical record forms including information on the endoscopic findings, MRI findings and digital examination.
They will be followed ever third month for the first two years as follows:
- PET-CT is optional, but can be performed at inclusion
- Pelvic MRI including diffusion weighted imaging according to appendix C.
- Clinical examination
- Endoscopy (flexible sigmoidoskopy) with photodocumentation
- CEA
After two years the patients will be followed every six month with:
- Pelvic MRI including diffusion weighted imaging according to appendix as at baseline
- Clinical examination
- Endoscopy with photodocumentation
- CEA
SurgeryProcedure or surgery
Surgery according to recommendations from the multidisciplinary group in patients that prefer surgery to a watch and wait strategy
MRIDevice
| Study group | Role | What they receive |
|---|---|---|
| No surgery | Experimental | Patients with indication of complete response on follow-up MRI will undergo endoscopy, and digital rectal examination to ascertain complete response. MRI together with documentation from endoscopy will be reviewed at the Regional University Hospital to establish agreement regarding interpretation. Receives: Procedure: endoscopy; Device: MRI |
| Surgery | Active comparator | Patients with indication of complete response on follow-up MRI will undergo endoscopy, and digital rectal examination to ascertain complete response. MRI together with documentation from endoscopy will be reviewed at the Regional University Hospital to establish agreement regarding interpretation. Patients with complete response will be offered watch and wait strategy, but the patients that want surgery will be operated according to the multi disciplinary conference decision. Receives: Procedure: Surgery; Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease free survival.
Thus this includes patients that have had regrowth and been operated for their tumour. Includes metastastic surgery as well
Measured: 3 years
Secondary outcomes (8)
Percentage re-growth during follow-up
Endoscopic or MRI indication of regrowth
Measured: 10 years
Local recurrence after salvage surgery due to regrowth
Local recurrence as shown by MRI, endoscopy or digital examination
Measured: 10 years
Results after surgery for re-growth
Complications and mortality after surgery
Measured: 10 years
Long-term survival
Overall survival
Measured: 10 years
Number of patients with no response, partial response and complete response.
Number of patients in each group - no response, partial response and complete response
Measured: Accrual period - probably 4 years
Anorectal function measured by LARS score
Anorectal function measured by LARS and then compared to patients operated.
Measured: 5 years
Quality of life measured by a clinometric approach
QoL measurments sent to patients
Measured: up to 24 months
Health economic evaluation
A cost efficiency analysis
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study startJan 2017
- Primary completionDec 2025 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- All patients with complete response defined as described above will be offered to enter the study
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Eva Angenete, Sahlgrenska University Hospital
- Investigators
- Eva Angenete, M.D., Ph.D., Principal investigator, Sahlgrenska Academy at Gothenburg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125343
- Sponsor's protocol ID
- WoW
- Acronym
- WoW
- Status last verified
- Nov 2023
- First submitted
- 20 Mar 2017
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective National Cohort Study for Patients With Advanced Rectal Cancer - is it Possible to Induce Remission and Avoid Surgery - Watch and Wait?
- ClinicalTrials.gov ID
- NCT03125343
- Acronym / sponsor ID
- WoW / WoW
- Conditions
- Rectal Neoplasms
- Keywords
- radiotherapy, chemotherapy, complete response
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Apr 2017 (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.
A national cohort study with all patients scheduled for neoadjuvant treatment with (chemo)radiotherapy or short course radiotherapy with delayed surgery 6-8 weeks) for rectal cancer staged as cT4bNX/anycTanycN and cMRF+/anycTanycN and lateral lymph nodes on MRI (and patients that have been offered short course raditotherapy with delayed surgery due to various reasons). The tumours are positioned midrectal or low and are palpable with the finger. The patients offered this treatment after recommendations on their local multidisciplinary tumour board will be will be informed and offered to participate in the study. Patients scheduled for short course radiotherapy with immediate surgery cannot be included.
Detailed description
- Biopsies and blood from patients with rectal cancer subject to neoadjuvant treatment with (chemo)radiotherapy or radiotherapy 5x5 Gy with at least 6-8 weeks wait until surgery. All patients will be asked to answer a QoL questionnaire (appendix C) to cover their experiences of the neaodajvuant treatment. (Answered at diagnosis and at evaluation of treatment and decision of surgery or inclusion in the Watch and Wait part of the study).
All patients will undergo scheduled (chemo)radiotherapy according to national guidelines. The patients with chemoradiotherapy will be evaluated at 8-10 weeks after completed treatment (25) with pelvic MRI. After this evaluation at 8-10 weeks patients with suspected complete response or near complete response will examined according to the protocol below.
All patients that are considered to have complete response will be offered a "Watch and wait" approach with follow-up according to the protocol. They will then be followed at one of the Regional University Hospitals within their catchment are.
All patients with a palpable rectal cancer staged as cT4bNX/anycTanycN and cMRF+/anycTanycN and lateral lymph nodes on MRI (and patients that have been offered short course raditotherapy with delayed surgery due to various reasons) that does not achieve complete response will serve as control and will be treated with surgery as planned prior to initiation of (chemo)radiotherapy.
Patients with indication of complete response on follow-up MRI will undergo endoscopy, and digital rectal examination to ascertain complete response. MRI together with documentation from endoscopy will be reviewed at the Regional University Hospital to extablish agreement regarding interpretation. All the below mentioned criteria must be fullfilled to be considered complete response:
- No suspicious metastatic lymph nodes or evidence of remaining tumour on MRI. In the majority of cases a complete response on MRI will be seen as areas of homogeneous fibrosis. Absence of any remaining pathological tissue is seen in a minority of cases.
- Endoscopic examination with light/white mucosa or scar, telangiectasies. Prescence of fibrosis and oedema.
- No palpable tumour on clinical examination (26).
In the spring of 2023 200 pts included. An amendment was sent to the ethical review board to enable continued inclusion while the initial 200 pts are analyzed. This has been approved and the study has thus planned continuation for another 2-3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All patients with complete response defined as described above will be offered to enter the study
| Arm | Type | Receives |
|---|---|---|
| No surgery | Experimental | Procedure: endoscopy, Device: MRIPatients with indication of complete response on follow-up MRI will undergo endoscopy, and digital rectal examination to ascertain complete response. MRI together with documentation from endoscopy will be reviewed at the Regional University Hospital to establish agreement regarding interpretation. |
| Surgery | Active comparator | Procedure: Surgery, Device: MRIPatients with indication of complete response on follow-up MRI will undergo endoscopy, and digital rectal examination to ascertain complete response. MRI together with documentation from endoscopy will be reviewed at the Regional University Hospital to establish agreement regarding interpretation. Patients with complete response will be offered watch and wait strategy, but the patients that want surgery will be operated according to the multi disciplinary conference decision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All patients in Sweden with a palpable rectal cancer staged as cT4bNX/anycTanycN and cMRF+/anycTanycN and lateral lymph nodes on MRI considered appropriate for 5x5 Gy and 6-8 weeks of wait prior to surgery according to Stockholm III (28) or a palpable rectal cancer staged as cT4bNX/anycTanycN and cMRF+/anycTanycN and lateral lymph nodes on MRI a planned schedule for CRT according to the Swedish National Program for rectal cancer scheduled for neoadjuvant therapy are possible to include.
- The study includes two parts, where part one is optional in including hospitals. The aim of the biopsy substudy to identify tumour and plasma markers for complete response, thus all patients that will receive (chemo)radiotherapy in the neoadjuvant setting are included to provide a control for the biopsies.
- For the WoW part of the study all patients that achieve complete response after neoadjuvant treatment according to the specified criteria above can be included in the Watch and Wait protocol. In detail this includes patients with:
- Midrectal or low rectal cancers that are palpable and considered with an indication of 5x5 Gy and long wait (6-8 weeks) (the indication for waiting may be logistics, co-morbidity, advanced age):
- cT4bNX
Key exclusion criteria (3 listed)
- No informed consent received for participation.
- Patients with rectal cancer that is scheduled for (chemo) radiotherapy but is not palpable during rectal examination (10-15 cm) as this cannot be examined by digital examination and followed as scheduled.
- Contraindication for MRI such as presence of non compatible metallic implants or claustrophobia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopyContinuous follow-up. All patients with complete response will be followed for ten years. Details from the follow-up schedule will be registered in clinical record forms including information on the endoscopic findings, MRI findings and digital examination. They will be followed ever third month for the first two years as follows: * PET-CT is optional, but can be performed at inclusion * Pelvic MRI including diffusion weighted imaging according to appendix C. * Clinical examination * Endoscopy (flexible sigmoidoskopy) with photodocumentation * CEA After two years the patients will be followed every six month with: * Pelvic MRI including diffusion weighted imaging according to appendix as at baseline * Clinical examination * Endoscopy with photodocumentation * CEA | Procedure or surgery | No surgery |
| SurgerySurgery according to recommendations from the multidisciplinary group in patients that prefer surgery to a watch and wait strategy | Procedure or surgery | Surgery |
| MRI | Device | No surgery, Surgery |
Primary outcome
3-year disease free survival.
Time frame: 3 years
Thus this includes patients that have had regrowth and been operated for their tumour. Includes metastastic surgery as well
8 secondary outcomes
Percentage re-growth during follow-up
Time frame: 10 years
Local recurrence after salvage surgery due to regrowth
Time frame: 10 years
Results after surgery for re-growth
Time frame: 10 years
Long-term survival
Time frame: 10 years
Number of patients with no response, partial response and complete response.
Time frame: Accrual period - probably 4 years
Anorectal function measured by LARS score
Time frame: 5 years
Quality of life measured by a clinometric approach
Time frame: up to 24 months
Health economic evaluation
Time frame: 5 years
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 7 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
Eva Angenete, M.D., Ph.D. contact
Eva Angenete, M.D., Ph.D. principal investigator
Sahlgrenska Academy at Gothenburg University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopy, Surgery and MRI in people with Rectal Neoplasms, run by Sahlgrenska University Hospital at 2 sites in Sweden.
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 6 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: looking for participants now, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
Contact Eva Angenete, M.D., Ph.D. (eva.angenete@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease free survival. (time frame: 3 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 7 Nov 2023.