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

NCT03402477 | Terminated DMC

• 1 other identifier: SUSID674
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 7

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.

Conditions

Rectal Cancer

Keywords

locally advanced, neo-adjuvant treatment, Watch & Wait

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The rate of cCR after preoperative CRT

  Baseline to 5 years

• Metachronous distant metastases in patients following the W&W protocol

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helse Stavanger HF: lead
• University Hospital of North Norway: collaborator
• St. Olavs Hospital: collaborator
• Helse-Bergen HF: collaborator
• Sorlandet Hospital HF: collaborator
• Oslo University Hospital: collaborator
• University Hospital, Akershus: collaborator
• Norwegian Institute of Public Health: collaborator

Study Sites (7)

Haukeland University Hospital

Bergen, Norway

Location

Sørlandet Hospital Kristiansand

Kristiansand, Norway

Location

Akershus University Hospital

Lørenskog, 1478, Norway

Location

Oslo University Hospital

Oslo, Norway

Location

Stavanger University Hospital

Stavanger, Norway

Location

University Hospital Northern Norway

Tromsø, Norway

Location

St. Olavs Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Hartwig Kørner, MD, PhD

  Helse Stavanger HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 18, 2018
• Study Start: January 10, 2018
• Primary Completion: November 19, 2020
• Study Completion: April 19, 2024
• Last Updated: April 24, 2024

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (7)