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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05883800
Other study ID # 402056
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 22, 2023
Est. completion date December 31, 2031

Study information

Verified date July 2023
Source Haukeland University Hospital
Contact Sara Pilskog, PhD
Phone 95890659
Email sara.margareta.cecilia.pilskog@helse-bergen.no
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 61
Est. completion date December 31, 2031
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
On-couch adaptive radiotherapy
A new treatment plan, guided by volumetric images, is created at each treatment session

Locations

Country Name City State
Norway Haukeland University Hospital Bergen

Sponsors (1)

Lead Sponsor Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Other Bowel exposure Radiation dose to bowel Treatment week 1-2
Other Immunogenic alterations from TNT Presence of selected immune cells Baseline and at surgery i.e. in treatment week 23-28
Other Perfusion changes on MR Changes in perfusion from contrast-enhanced MR Baseline and at MR response evaluation up to week 25 of the study
Other Diffusion changes on MR Changes in diffusion from diffusion-weighted MR Baseline and at MR response evaluation up to week 25 of the study
Other Patient reported general outcome measures Quality of life using EORTC qlq-c30 questionnaire Baseline and up to 5 years of the study
Other Patient reported colo-rectal outcome measures Quality of life using EORTC qlq-cr29 questionnaire Baseline and up to 5 years of the study
Other Patient reported bowel-related outcome measures Quality of life using low anterior resection syndrome (LARS) score Baseline and up to 5 years of the study
Primary Incidence 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. Up to administration of the last course of chemotherapy or week 22, whichever comes first
Secondary Number of participants that require alteration of chemotherapy due to toxicity Alterations of chemotherapy, defined as dose-reduction or pre-maturely stopping chemotherapy administration From treatment week 3 up to week 20
Secondary 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.
5 years after surgery
Secondary Number of patients with pathological complete response (pCR) pCR after completion of the intended or tolerated TNT At surgery i.e. in treatment week 23-28
Secondary Tumour regression grade Radiological based clinical response evaluation on MR (mrTRG) Baseline to response evaluation on MR in up to week 25 of the study
Secondary Overall survival Overall survival from time of inclusion until death Follow-up until 5 years or death
Secondary 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. 5 years
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