None listed
Conditions
Brief summary
The aim of this study to assess the feasibility of a diffusion-weighted magnetic resonance imaging (DW-MRI) guided radiotherapy boost for locally advanced rectal cancer. Who is it for? Patients older than 18 years of age, with rectal cancer confirmed on biopsy, undergoing curative-intent neoadjuvant radiotherapy (+/- chemotherapy) 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 treatment prior to the usual 5-6 weeks of radiotherapy; and completion of brief quality of life questionnaires before, during and after treatment. A key part of the study is also to assess any treatment-related toxicity 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 given with concurrent chemotherapy and therefore reduce the need for surgery for patients.
Interventions
This study will evaluate the feasibility of a diffusion-weighted magnetic resonance imaging (DW-MRI) guided radiotherapy boost for locally advanced rectal cancer.
Patients will undergo pre-treatment MRI in the fortnight prior to commencing radiotherapy (+/- chemotherapy). Boost volume will be defined quantitatively according to intratumoural apparent diffusion coefficient (ADC) value. This volume will be targeted for a single-fraction 5-10Gy boost 3-5 days prior to commencing standard radiothe
This study will evaluate the feasibility of a diffusion-weighted magnetic resonance imaging (DW-MRI) guided radiotherapy boost for locally advanced rectal cancer. Patients will undergo pre-treatment MRI in the fortnight prior to commencing radiotherapy (+/- chemotherapy). Boost volume will be defined quantitatively according to intratumoural apparent diffusion coefficient (ADC) value. This volume will be targeted for a single-fraction 5-10Gy boost 3-5 days prior to commencing standard radiotherapy (50Gy delivered in 25 fractions). Treatment will be administered by the Radiation Oncology department at Sunshine Coast University Hospital (SCUH), Birtinya. Each treatment takes approximately 15 minutes per day. Patients will be reviewed once per week by radiation oncology medical staff as per normal practice. Patients will also be asked to complete a quality of life questionnaire at several timepoints prior to, during and following completion of the treatment course, which will take an additional 5-10 minutes on each occasion.
Sponsors
Dr Myo Min
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
- Able to give informed consent - Histologically-proven primary rectal adenocarcinoma within 0-10cm of anorectal junction on MRI or enteroscopy (T3, T4 or node positive disease with no evidence of metastatic spread (M0) on staging CT-chest/abdomen/pelvis (i.e. stage II/III disease)) - Patient undergoing curative intent neoadjuvant radiotherapy +/- chemotherapy -- Neoadjuvant radiotherapy must be first component of neoadjuvant therapy (i.e. no induction course) -- Concurrent chemotherapy can include capecitabine or fluorouracil
Exclusion criteria
- Contraindication to MRI studies (e.g. significant claustrophobia, incompatible pacemaker/implantable defibrillator, implanted metals) - Patients receiving total neoadjuvant chemotherapy - Significant imaging artefact precluding accurate MRI-guided radiotherapy planning (bilateral hip replacement etc.) - Previous radiotherapy to pelvis - Other malignancy conferring life expectancy of less than 3 years - Pregnancy - Active inflammatory bowel disease - Prior diagnosis of connective tissue disorder
Outcome results
None listed