Clinical trial NCT03402477: "Watch and Wait" After Neo-adjuvant Chemoradiotherapy for Primary Locally Advanced Rectal Cancer.
Official title: "Watch and Wait" in Patients With Complete Clinical Response (cCR) After Neo-adjuvant Chemoradiotherapy for Primary Locally Advanced Rectal Cancer.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rectal Cancer
Keywords: locally advanced, neo-adjuvant treatment, Watch & Wait
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: University Hospital of North Norway
name: St. Olavs Hospital
name: Helse-Bergen HF
name: Sorlandet Hospital HF
name: Oslo University Hospital
name: University Hospital, Akershus
name: Norwegian Institute of Public Health
First posted: 2018-01-18
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients in Norway with rectal cancer treated with neo-adjuvant radio-chemotherapy according to Norwegian national guidelines, who have complete clinical response at 6-12 weeks after fulfilled treatment

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.


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

Primary outcomes:
measure: Rate of regrowth
timeFrame: Baseline to 5 years
Secondary outcomes:
measure: The rate of cCR after preoperative CRT
timeFrame: Baseline to 5 years
measure: Metachronous distant metastases in patients following the W&W protocol
timeFrame: Baseline to 5 years
measure: Overall and cancer-specific survival protocol compared to patients with ypCR, i.e. patients with complete pathologic response after resection.
timeFrame: Baseline to 5 years
measure: Patient-reported outcome measures - rectal function (LARS) and quality of life (QoL)
timeFrame: Baseline to 5 years
measure: Patient-reported outcome measures - quality of life (LARS) and quality of life (QoL)
timeFrame: Baseline to 5 years
measure: Sensitivity, specificity and overall diagnostic accuracy of MRI with regard to the diagnosis of complete response
timeFrame: Baseline to 5 years
measure: Diagnostic accuracy of MRI to detect regrowth during follow-up after complete response
timeFrame: Baseline to 5 years
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Kristiansand
country: Norway
facility: Sørlandet Hospital Kristiansand
city: Lørenskog
country: Norway
facility: Akershus University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Stavanger
country: Norway
facility: Stavanger University Hospital
city: Tromsø
country: Norway
facility: University Hospital Northern Norway
city: Trondheim
country: Norway
facility: St. Olavs Hospital
Study officials:
affiliation: Helse Stavanger HF
name: Hartwig Kørner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: