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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Intervention: daily on-couch adaptive radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| On-couch adaptive radiotherapy | Radiation | A new treatment plan, guided by volumetric images, is created at each treatment session |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of patients with disease related treatment failure |
| Measure | Description | Time Frame |
|---|---|---|
| Bowel exposure | Radiation dose to bowel | Treatment week 1-2 |
| Immunogenic alterations from TNT | Presence of selected immune cells | Baseline and at surgery i.e. in treatment week 23-28 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Pilskog, PhD | Contact | 95890659 | 0047 | sara.margareta.cecilia.pilskog@helse-bergen.no |
| Unn Hege Lilleøren, MD | Contact | 92054547 | 0047 | unn.hege.lilleoren@helse-bergen.no |
| Name | Affiliation | Role |
|---|---|---|
| Unn Hege Lilleøren, MD | Dept. of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Recruiting | Bergen | 5021 | Norway |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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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 |
| 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 |
| 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 |
| Overall survival | Overall survival from time of inclusion until death | Follow-up until 5 years or death |
| 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 |
| Perfusion changes on MR | Changes in perfusion from contrast-enhanced MR | Baseline and at MR response evaluation up to week 25 of the study |
| Diffusion changes on MR | Changes in diffusion from diffusion-weighted MR | Baseline and at MR response evaluation up to week 25 of the study |
| Patient reported general outcome measures | Quality of life using EORTC qlq-c30 questionnaire | Baseline and up to 5 years of the study |
| Patient reported colo-rectal outcome measures | Quality of life using EORTC qlq-cr29 questionnaire | Baseline and up to 5 years of the study |
| 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 |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |