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Trial Title:
Total Neoadjuvant Treatment Combined With Adaptive Radiotherapy for Rectal Cancer
NCT ID:
NCT05883800
Condition:
Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
On-couch adaptive radiotherapy
Description:
A new treatment plan, guided by volumetric images, is created at each treatment session
Arm group label:
Intervention
Other name:
online ART
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.
Detailed description:
This is a prospective single-arm study investigating the benefit of on-couch adaptation
for locally advanced rectal cancer patients prescribed with pre-operative sequential
short-course radiotherapy (RT) followed by Oxaliplatin-combined chemotherapy (mFOLFOX(6)
or CAPOX). On-couch adaptation, where the radiation dose is tailored to the anatomy of
the patient at each radiotherapy session. Firstly, the study will investigate if on-couch
adaptation result in less gastro-intestinal adverse events, secondly it will reveal if
this possible reduction lead to more patients being able to fulfill all cycles of
prescribed chemotherapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Previous rectal cancer treatment
- Previous irradiation to the treatment area e.g. prostate cancer
- Hip prosthesis
- Contraindications to MRI
- Pregnancy
- Abnormal DPYD genotype
- Known contraindication to 5-FU, Capecitabine or Oxaliplatin as judged by the
investigators
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Haukeland University Hospital
Address:
City:
Bergen
Zip:
5021
Country:
Norway
Status:
Recruiting
Start date:
June 22, 2023
Completion date:
December 31, 2031
Lead sponsor:
Agency:
Haukeland University Hospital
Agency class:
Other
Source:
Haukeland University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05883800
