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

Helse Stavanger HF7 sites in 1 country86 target enrollmentJanuary 10, 2018

ConditionsRectal Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rectal Cancer
Sponsor: Helse Stavanger HF
Enrollment: 86
Locations: 7
Primary Endpoint: Rate of regrowth
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 10, 2018

End Date

April 19, 2024

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Helse Stavanger HF

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Rate of regrowth

Time Frame: Baseline to 5 years

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.

Secondary Outcomes

Metachronous distant metastases in patients following the W&W protocol(Baseline to 5 years)
The rate of cCR after preoperative CRT(Baseline to 5 years)
Overall and cancer-specific survival protocol compared to patients with ypCR, i.e. patients with complete pathologic response after resection.(Baseline to 5 years)
Patient-reported outcome measures - rectal function (LARS) and quality of life (QoL)(Baseline to 5 years)
Patient-reported outcome measures - quality of life (LARS) and quality of life (QoL)(Baseline to 5 years)
Sensitivity, specificity and overall diagnostic accuracy of MRI with regard to the diagnosis of complete response(Baseline to 5 years)
Diagnostic accuracy of MRI to detect regrowth during follow-up after complete response(Baseline to 5 years)