Rectal Cancer
Conditions
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.
Interventions
RADIATIONOn-couch adaptive radiotherapy
A new treatment plan, guided by volumetric images, is created at each treatment session
Sponsors
Haukeland University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of acute gastro-intestinal toxicity equal or higher than grade 2 | Up to administration of the last course of chemotherapy or week 22, whichever comes first | Incidence of acute gastro-intestinal toxicity from therapy graded according to CTCAE ver. 5. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants that require alteration of chemotherapy due to toxicity | From treatment week 3 up to week 20 | Alterations of chemotherapy, defined as dose-reduction or pre-maturely stopping chemotherapy administration |
| Number of patients with disease related treatment failure | 5 years after surgery | 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. |
| Number of patients with pathological complete response (pCR) | At surgery i.e. in treatment week 23-28 | pCR after completion of the intended or tolerated TNT |
| Tumour regression grade | Baseline to response evaluation on MR in up to week 25 of the study | Radiological based clinical response evaluation on MR (mrTRG) |
| Overall survival | Follow-up until 5 years or death | Overall survival from time of inclusion until death |
| Incidence of late gastro-intestinal toxicity equal or higher than grade 2 | 5 years | Incidence of late gastro-intestinal events (e.g.diarrhea, rectal hemorrhage, rectal and/or abdominal pain) from therapy graded according to CTCAE ver. 5. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Bowel exposure | Treatment week 1-2 | Radiation dose to bowel |
| Immunogenic alterations from TNT | Baseline and at surgery i.e. in treatment week 23-28 | Presence of selected immune cells |
| Perfusion changes on MR | Baseline and at MR response evaluation up to week 25 of the study | Changes in perfusion from contrast-enhanced MR |
| Diffusion changes on MR | Baseline and at MR response evaluation up to week 25 of the study | Changes in diffusion from diffusion-weighted MR |
| Patient reported general outcome measures | Baseline and up to 5 years of the study | Quality of life using EORTC qlq-c30 questionnaire |
| Patient reported colo-rectal outcome measures | Baseline and up to 5 years of the study | Quality of life using EORTC qlq-cr29 questionnaire |
| Patient reported bowel-related outcome measures | Baseline and up to 5 years of the study | Quality of life using low anterior resection syndrome (LARS) score |
Countries
Norway
Contacts
Primary ContactSara Pilskog, PhD
Backup ContactUnn Hege Lilleøren, MD
Outcome results
None listed