Clinical trial NCT05883800: Total Neoadjuvant Treatment Combined With Adaptive Radiotherapy for Rectal Cancer
Official title: TNT-RECORD:Total Neoadjuvant Treatment in Rectal Cancer With On-couch Adaptive Radiotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Incidence of acute gastro-intestinal toxicity equal or higher than grade 2
timeFrame: Up to administration of the last course of chemotherapy or week 22, whichever comes first
Secondary outcomes:
measure: Number of participants that require alteration of chemotherapy due to toxicity
timeFrame: From treatment week 3 up to week 20
measure: Number of patients with disease related treatment failure
timeFrame: 5 years after surgery
measure: Number of patients with pathological complete response (pCR)
timeFrame: At surgery i.e. in treatment week 23-28
measure: Tumour regression grade
timeFrame: Baseline to response evaluation on MR in up to week 25 of the study
measure: Overall survival
timeFrame: Follow-up until 5 years or death
measure: Incidence of late gastro-intestinal toxicity equal or higher than grade 2
timeFrame: 5 years
Other outcomes:
measure: Bowel exposure
timeFrame: Treatment week 1-2
measure: Immunogenic alterations from TNT
timeFrame: Baseline and at surgery i.e. in treatment week 23-28
measure: Perfusion changes on MR
timeFrame: Baseline and at MR response evaluation up to week 25 of the study
measure: Diffusion changes on MR
timeFrame: Baseline and at MR response evaluation up to week 25 of the study
measure: Patient reported general outcome measures
timeFrame: Baseline and up to 5 years of the study
measure: Patient reported colo-rectal outcome measures
timeFrame: Baseline and up to 5 years of the study
measure: Patient reported bowel-related outcome measures
timeFrame: Baseline and up to 5 years of the study
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Dept. of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway
name: Unn Hege Lilleøren, MD
role: PRINCIPAL_INVESTIGATOR
References: