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Clinical Trials in Sweden / NCT03125343
Recruiting Not applicable

Watch and Wait as Treatment for Patients With Rectal Cancer

NCT03125343 · tracked via the Priya Life Science Sweden tracker
Sponsor
Sahlgrenska University Hospital
Phase
Not applicable
Started
2017-01
Last updated
2023-11-07

Condition(s) studied

Rectal Neoplasms

Investigational drug(s) / intervention(s)

endoscopySurgeryMRI

endoscopy: 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

Surgery: Surgery according to recommendations from the multidisciplinary group in patients that prefer surgery to a watch and wait strategy

Study 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 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 Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Dept. of Surgery, Sahlgrenska University Hospital/Ostra Gothenburg Sweden Recruiting
Karolinska Institutet Stockholm Sweden Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03125343 on ClinicalTrials.gov ↗ ← All trials in Sweden