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 Type
OBSERVATIONAL
Enrollment
86
Haukeland University Hospital
Bergen, Norway
Sørlandet Hospital Kristiansand
Kristiansand, Norway
Akershus University Hospital
Lørenskog, Norway
Oslo University Hospital
Oslo, Norway
Stavanger University Hospital
Stavanger, Norway
University Hospital Northern Norway
Tromsø, Norway
St. Olavs Hospital
Trondheim, Norway
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.
Time frame: Baseline to 5 years
The rate of cCR after preoperative CRT
To calculate the rate of cCR in an national unselected cohort
Time frame: 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
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.
To analyse the overall and cancer-specific survival of patients with cCR following the W\&W
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to 5 years
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