None listed
Conditions
Brief summary
The aim of this study to assess the feasibility of a functional imaging-guided short course radiotherapy boost dose for adults with locally advanced rectal cancer. Who is it for? Patients older than 18 years of age, with rectal cancer confirmed on biopsy, undergoing curative-intent radiotherapy prior to surgery may be eligible for this study. Study details Participation in this trial will require undergoing an additional MRI scan prior to starting treatment; one extra day of radiotherapy treatment prior to the usual 1 weeks of radiotherapy; and completion of brief quality of life questionnaires before, during and after treatment. Participants will also be asked if the research team may review their medical information collected as part of their treatment. A key part of the study is also to assess any treatment-related side effects and your quality of life during and after treatment to ensure the additional dose does not have any adverse effects. It is hoped that this research will help to improve proportion of patients that completely respond to radiation treatment prior to surgical removal of bowel cancer, which may reduce the need for this invasive surgery for patients in future.
Interventions
The study will utilise a single-arm prospective design to evaluate the feasibility of a radiation boost dose using functional imaging data in a cohort of 15-30 locally advanced rectal cancer patients recruited across 18-36 months at Sunshine Coast University Hospital (SCUH).
Pre-treatment diffusion weighted magnetic resonance imaging (DW-MRI) scans will be used to delineate the hypercellular regions within the gross tumour volume (GTV) for the radiation boost dose. The pre-treatment DW-MRI sca
The study will utilise a single-arm prospective design to evaluate the feasibility of a radiation boost dose using functional imaging data in a cohort of 15-30 locally advanced rectal cancer patients recruited across 18-36 months at Sunshine Coast University Hospital (SCUH). Pre-treatment diffusion weighted magnetic resonance imaging (DW-MRI) scans will be used to delineate the hypercellular regions within the gross tumour volume (GTV) for the radiation boost dose. The pre-treatment DW-MRI scan will be performed approximately 2 weeks prior to the radiation boost dose. The radiation boost dose will be delivered in a single radiotherapy session only, with this session taking approximately 30-45 minutes. Specifically, these regions will receive an additional fraction of 5-10Gy within 14 days prior to commencing standard short course radiation therapy (SCRT) (25Gy in 5 fractions). The study will start with a 5Gy boost for the first 5-10 patients, then an interim safety analysis will be performed. The next 5-10 patients will receive a 7Gy boost with another interim safety analysis, then the final 5-10 patients will receive a 10Gy boost. The dose for any patient may be reduced to the previously given radiation dose level if deemed necessary to meet organ at risk dose constraints for any given patient. Adherence will be monitored by checking the electronic medical record (MOSAIQ software) for the recorded treatment.
Sponsors
Sunshine Coast University Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- 18 years or older - Able to give informed consent - Histologically-proven primary rectal adenocarcinoma within 0-10cm of anorectal junction or below the peritoneal reflection on MRI or endoscopic assessment: - T3, T4 or node positive disease with either no evidence of metastatic disease (M0) or limited metastatic disease (M1) where the MDT has recommended curative intent treatment, on staging CT-chest/abdomen/pelvis (i.e. stage II/III or selected oligometastatic disease) - Patient recommended at colorectal multidisciplinary team meeting to undergo curative intent neoadjuvant short course radiotherapy
Exclusion criteria
- Contraindication to MRI studies o Significant claustrophobia o Pacemaker/implantable defibrillator o Implanted metals - Significant imaging artefact precluding accurate MRI-guided radiotherapy planning (bilateral hip replacement etc.) - Previous radiotherapy to pelvis - Participation in another rectal cancer treatment related clinical trial - Other malignancy/comorbidity conferring life expectancy of less than 1 year - Pregnancy - Active inflammatory bowel disease - Prior diagnosis of connective tissue disorder
Outcome results
None listed