Rectal Cancer Clinical Trial
— TNT-RECORDOfficial title:
TNT-RECORD:Total Neoadjuvant Treatment in Rectal Cancer With On-couch Adaptive Radiotherapy
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Norway | Haukeland University Hospital | Bergen |
Lead Sponsor | Collaborator |
---|---|
Haukeland University Hospital |
Norway,
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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