Trials / Terminated
TerminatedNCT03402477
"Watch and Wait" After Neo-adjuvant Chemoradiotherapy for Primary Locally Advanced Rectal Cancer.
"Watch and Wait" in Patients With Complete Clinical Response (cCR) After Neo-adjuvant Chemoradiotherapy for Primary Locally Advanced Rectal Cancer.
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 86 (actual)
- Sponsor
- Helse Stavanger HF · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Timeline
- Start date
- 2018-01-10
- Primary completion
- 2020-11-19
- Completion
- 2024-04-19
- First posted
- 2018-01-18
- Last updated
- 2024-04-24
Locations
7 sites across 1 country: Norway
Source: ClinicalTrials.gov record NCT03402477. Inclusion in this directory is not an endorsement.