Standard Dose Versus High Dose of Radiotherapy in Rectal Preservation With Chemo-radiotherapy in Rectal Cancer Patients
Recruiting
Phase 3
Interventional Study
Cancer of Rectum
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 162 (estimated)
- Sponsor
- Vejle Hospital · Other
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About This Trial
In recent years, an increasing number of retrospective and prospective observational studies have indicated that a subset of rectal cancer patients may avoid surgery if they can achieve a complete response to chemoradiotherapy. Prospective trials, including the previous Danish Watchful Waiting trials (NCT00952926, NCT02438839) in early rectal cancer have demonstrated high levels of organ preservat…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Histopathologically verified adenocarcinoma of the rectum
* MDT conference finds patient a candidate for rectal resection
* Clinical tumor category cT1-3
* MRI findings
* Maximal cross-sectional size of 4.5 cm (axial plane relative to the rectum)
* Lowest edge of tumor lo…
Contacts