"Watch and Wait" After Neo-adjuvant Chemoradiotherapy for Primary Locally Advanced Rectal Cancer.

Rectal Cancer Clinical Trial

— NORWAIT  

Official title:

"Watch and Wait" in Patients With Complete Clinical Response (cCR) After Neo-adjuvant Chemoradiotherapy for Primary Locally Advanced Rectal Cancer.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03402477
• Other study ID #: SUSID674
• Status: Terminated
• Start date: January 10, 2018
• Est. completion date: April 19, 2024

Study information

• Verified date: October 2020
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 86
• Est. completion date: April 19, 2024
• Est. primary completion date: November 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Locations

Country	Name	City	State
Norway	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

Sponsors (8)

Lead Sponsor	Collaborator
Helse Stavanger HF	Cancer Registry of Norway, Helse-Bergen HF, Oslo universitetssykehus HF, Sorlandet Hospital HF, St. Olavs Hospital, University Hospital of North Norway, University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 5 years
Secondary	The rate of cCR after preoperative CRT	To calculate the rate of cCR in an national unselected cohort	Baseline to 5 years
Secondary	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	Baseline to 5 years
Secondary	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	Baseline to 5 years
Secondary	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	Baseline to 5 years
Secondary	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	Baseline to 5 years
Secondary	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	Baseline to 5 years
Secondary	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	Baseline to 5 years