TNT-RECORD:Total Neoadjuvant Treatment in Rectal Cancer With On-couch Adaptive Radiotherapy

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Diarrhea was the most frequently reported severe adverse event in the treatment regime of pre-operative sequential short-course radiotherapy followed by chemotherapy (so called total neo-adjuvant treatment). This study therefore investigates the benefit of on-couch adaptation for locally advanced rectal cancer patients undergoing this treatment regime.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with loco-regional advanced rectal adenocarcinoma with clinical indications for short-course with TNT chemotherapy i.e. having at least one of the following T4a, CRM+ (≤1 mm), N1c, N2 or extramural vascular invasion (EMVI+). Patients presenting at least one of these criteria in addition to involvement of the pelvic sidewall lymph nodes (PSW) can optionally be considered.

• ECOG status ≤ 1

• Being willing and able to give full written consent for participation

Locations
Other Locations
Norway
Haukeland University Hospital
RECRUITING
Bergen
Contact Information
Primary
Sara Pilskog, PhD
sara.margareta.cecilia.pilskog@helse-bergen.no
95890659
Backup
Unn Hege Lilleøren, MD
unn.hege.lilleoren@helse-bergen.no
92054547
Time Frame
Start Date: 2023-06-22
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 61
Treatments
Experimental: Intervention
Intervention: daily on-couch adaptive radiotherapy
Related Therapeutic Areas
Sponsors
Leads: Haukeland University Hospital

This content was sourced from clinicaltrials.gov