Contact Radiotherapy for Rectal Cancer
ConditionRectal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlexander Valdman
About this trial
The aim of the CORRECT phase 2 study is to show non-inferiority of Contact x-ray brachytherapy (CXB) + short-course radiotherapy (SCRT) compared to the experimental arm of the OPERA trial in organ preservation for early and early intermediate rectal cancer (cT1-3abN1).
Eligibility criteria
Qualifiers
cT1-cT3ab, < 5 cm largest diameter and < ½ circumference (MRI staging), N0-N1 (<= 3 nodes < 8mm diameter), M0
Performance status (ECOG) 0-1
Operable patient
Tumor accessible to endocavitary contact X-ray brachytherapy with a distance from the lower tumor border to the anal verge ≤10 cm
Disqualifiers
Inoperable patient
T3cd, T4, T≥ 5cm, Involvement of more than half of the bowel circumference
Distance from the lower tumor border to the anal verge >10 cm
N2-status at diagnosis or N1 with any node>= 8 mm diameter
Trial design
Treatments tested in this trial
- Radiotherapy
- Short-course radiotherapy
- Contact x-ray brachytherapy
- Chemotherapy
Treatment groups
110 Participants
are divided into 2 treatment groupsSponsors and collaborators
Alexander Valdman
Lead sponsor
Karolinska University Hospital
Sponsor institution
Uppsala University Hospital
Collaborator
Karolinska Institutet
Collaborator
Source ClinicalTrials.gov