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

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ClinicalTrials.gov Identifier: NCT03402477
Recruitment Status : Recruiting
First Posted : January 18, 2018
Last Update Posted : December 17, 2020
Sponsor:
Collaborators:
University Hospital of North Norway
St. Olavs Hospital
Helse-Bergen HF
Sorlandet Hospital HF
Oslo universitetssykehus HF
University Hospital, Akershus
Cancer Registry of Norway
Information provided by (Responsible Party):
Helse Stavanger HF

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.

Condition or disease
Rectal Cancer

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: "Watch and Wait" in Patients With Complete Clinical Response (cCR) After Neo-adjuvant Chemoradiotherapy for Primary Locally Advanced Rectal Cancer.
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2028



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. The rate of cCR after preoperative CRT [ Time Frame: Baseline to 5 years ]
    To calculate the rate of cCR in an national unselected cohort

  2. Metachronous distant metastases in patients following the W&W protocol [ Time Frame: Baseline to 5 years ]
    To calculate the rate of the occurrence of distant metastases in patients who undergo the watch & Wait program

  3. Overall and cancer-specific survival protocol compared to patients with ypCR, i.e. patients with complete pathologic response after resection. [ Time Frame: Baseline to 5 years ]
    To analyse the overall and cancer-specific survival of patients with cCR following the W&W

  4. Patient-reported outcome measures - rectal function (LARS) and quality of life (QoL) [ Time Frame: Baseline to 5 years ]
    To evaluate the effect of the Watch and wait program on rectal function by using the Low anterior resection syndrome (LARS) score

  5. Patient-reported outcome measures - quality of life (LARS) and quality of life (QoL) [ Time Frame: Baseline to 5 years ]
    To measure the effect of the Watch and wait program on quality of life by using the EORTC QLQ C30

  6. Sensitivity, specificity and overall diagnostic accuracy of MRI with regard to the diagnosis of complete response [ Time Frame: Baseline to 5 years ]
    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

  7. Diagnostic accuracy of MRI to detect regrowth during follow-up after complete response [ Time Frame: Baseline to 5 years ]
    To compare the accuracy of multi parametric MRI protocol with clinical examination during follow-up with regard to possible regrowth of the tumour



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03402477


Contacts
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Contact: Hartwig Kørner, MD, PhD 51518000 hartwig.korner@uib.no

Locations
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Norway
Haukeland University Hospital Recruiting
Bergen, Norway
Contact: Frank Pfeffer, MD, PhD    +4755975000    frank.pfeffer@helse-bergen.no   
Sørlandet Hospital Kristiansand Recruiting
Kristiansand, Norway
Contact: Christian Kersten, MD    +4791503738    Christian.Kersten@sshf.no   
Akershus University Hospital Recruiting
Lørenskog, Norway, 1478
Contact: Arne Færden, MD PhD    +4767960000    Arne.Engebreth.Faerden@ahus.no   
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Gro Wiedswang, MD PhD    +4722118080    gro.wiedswang@gmail.com   
Stavanger University Hospital Recruiting
Stavanger, Norway
Contact: Hartwig Kørner, MD, PhD    51518000    hartwig.korner@uib.no   
University Hospital Northern Norway Recruiting
Tromsø, Norway
Contact: Stig Norderval, MD PhD    +4777626000    stig.norderval@unn.no   
St. Olavs Hospital Recruiting
Trondheim, Norway
Contact: William J. Lossius, MD    +4772573000    William.J.Lossius@stolav.no   
Sponsors and Collaborators
Helse Stavanger HF
University Hospital of North Norway
St. Olavs Hospital
Helse-Bergen HF
Sorlandet Hospital HF
Oslo universitetssykehus HF
University Hospital, Akershus
Cancer Registry of Norway
Investigators
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Principal Investigator: Hartwig Kørner, MD, PhD Helse Stavanger HF
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Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT03402477    
Other Study ID Numbers: SUSID674
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Helse Stavanger HF:
locally advanced, neo-adjuvant treatment, Watch & Wait
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases