Watch and Wait as Treatment for Patients With Rectal Cancer (WoW)
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|ClinicalTrials.gov Identifier: NCT03125343|
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : September 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Rectal Neoplasms||Procedure: endoscopy Procedure: Surgery Device: MRI||Not Applicable|
• 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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All patients with complete response defined as described above will be offered to enter the study|
|Masking:||None (Open Label)|
|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?|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2024|
Experimental: No surgery
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.
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:
After two years the patients will be followed every six month with:
Active Comparator: Surgery
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.
Surgery according to recommendations from the multidisciplinary group in patients that prefer surgery to a watch and wait strategy
- 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
- Percentage re-growth during follow-up [ Time Frame: 10 years ]Endoscopic or MRI indication of regrowth
- Local recurrence after salvage surgery due to regrowth [ Time Frame: 10 years ]Local recurrence as shown by MRI, endoscopy or digital examination
- Results after surgery for re-growth [ Time Frame: 10 years ]Complications and mortality after surgery
- Long-term survival [ Time Frame: 10 years ]Overall survival
- Number of patients with no response, partial response and complete response. [ Time Frame: Accrual period - probably 4 years ]Number of patients in each group - no response, partial response and complete response
- Anorectal function measured by LARS score [ Time Frame: 5 years ]Anorectal function measured by LARS and then compared to patients operated.
- Quality of life measured by a clinometric approach [ Time Frame: up to 24 months ]QoL measurments sent to patients
- Health economic evaluation [ Time Frame: 5 years ]A cost efficiency analysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125343
|Contact: Eva Angenete, M.D., Ph.D.||firstname.lastname@example.org|
|Dept. of Surgery, Sahlgrenska University Hospital/Ostra||Recruiting|
|Gothenburg, Sweden, SE 416 85|
|Contact: Eva Angenete, MD,PhD +46313438410 email@example.com|
|Contact: Anna Martling, Professor|
|Principal Investigator:||Eva Angenete, M.D., Ph.D.||Sahlgrenska Academy at Gothenburg University|