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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
A new treatment plan, guided by volumetric images, is created at each treatment session
Haukeland University Hospital
Bergen, Norway
RECRUITINGIncidence of acute gastro-intestinal toxicity equal or higher than grade 2
Incidence of acute gastro-intestinal toxicity from therapy graded according to CTCAE ver. 5.
Time frame: Up to administration of the last course of chemotherapy or week 22, whichever comes first
Number of participants that require alteration of chemotherapy due to toxicity
Alterations of chemotherapy, defined as dose-reduction or pre-maturely stopping chemotherapy administration
Time frame: From treatment week 3 up to week 20
Number of patients with disease related treatment failure
Disease-related treatment failure include the first of any of the following events: (i) During treatment: Non-radical resection of primary tumor (R2 resection) or un-fit of for surgery due to progression, death from treatment (ii) During, or after treatment: Loco-regional recurrence (including regrowth after potential watch-and-wait), distant metastasis (including M re-staging at surgery), death from rectal cancer, second primary rectal cancer.
Time frame: 5 years after surgery
Number of patients with pathological complete response (pCR)
pCR after completion of the intended or tolerated TNT
Time frame: At surgery i.e. in treatment week 23-28
Tumour regression grade
Radiological based clinical response evaluation on MR (mrTRG)
Time frame: Baseline to response evaluation on MR in up to week 25 of the study
Overall survival
Overall survival from time of inclusion until death
Time frame: Follow-up until 5 years or death
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Incidence of late gastro-intestinal toxicity equal or higher than grade 2
Incidence of late gastro-intestinal events (e.g.diarrhea, rectal hemorrhage, rectal and/or abdominal pain) from therapy graded according to CTCAE ver. 5.
Time frame: 5 years