Cervical Cancer
Conditions
Keywords
cervical cancer, Stereotactic body radiotherapy (SBRT), Stereotactic ablative body radiotherapy (SABR), Brachytherapy
Brief summary
This study will evaluate the role of SBRT with the aim to reproduce high dose rate brachytherapy (HDR BT) dose distribution by means of external beam radiotherapy in the radical treatment in patients with LACC. The study will employ devices to accurately reproduce pelvic anatomy and mitigate target motion and will make use of real-time online tracking.
Detailed description
This is a phase I/II feasibility study of hypofractionated, image-guided Volumetric Modulated Arc Therapy (VMAT) Stereotactic Body Radiotherapy (SBRT) to LACC with the aim to reproduce HDR BT dose distribution by means of external beam radiotherapy in the radical treatment in patients with LACC. The study will employ devices to accurately reproduce pelvic anatomy and mitigate target motion and will make use of real-time online tracking. Eligible patients who consent to participate in the current study will receive 4 image-guided SBRT sessions to a prescription of 7 Gray per fraction to the LACC (HR-CTV) following whole pelvis external beam radiotherapy. SBRT will start within one week after whole pelvis external beam radiotherapy. The study will enroll a total of 30 patients. After treatment, patients will be followed-up at 1 month, at 3 months (+/- 1 week), at 6 months (+/- 4 weeks), and then every 6 months (+/- 6 weeks) until the end of the 3rd year, then annually until the 5th year. The equivalence of outcome and toxicity will be measured by comparing the data obtained in the study to literature data regarding the standard modality of brachytherapy. Patients' oncological outcomes, toxicity and quality of life data will be reported.
Interventions
RADIATIONSBRT
SBRT to reproduce HDR BT dose distribution in non-operated patients LACC
Sponsors
Fundacao Champalimaud
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients enrolled in this study must have received or planned to receive 45 to 50 Gray in 25 fractions to pelvis with a simultaneous integrated boost (SIB) of 55 Gray in 25 fractions to metabolic active primary lesion and of 55 Gray in 25 fractions to 62.5 Gray in 25 fractions suspicious nodes of prior external beam radiation therapy. Following completion, patients will receive a boost of 28 Gray in 4 fractions using Image Guided Stereotactic Body Radiation Therapy techniques.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cancer of the uterine cervix suitable for curative treatment with definitive radio-chemotherapy * Biopsy proven showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix. * Pelvic MRI. * MRI and Positron emission tomography (PET-CT) of the retroperitoneal space and abdomen at diagnosis is performed. * Stage IIB to IVA according to International Federation of Gynecological and Obstetrics (FIGO) and TNM guidelines. * Planning MRI with the applicator in place for the SBRT boost. * Para-aortic metastatic nodes below L1-L2 are allowed. * Study specific signed patient informed consent.
Exclusion criteria
* Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin. * Small cell neuroendocrine cancer, melanoma and other rare cancers in the cervix. * Metastatic disease above and beyond the retroperitoneal paraaortic L1-L2 interspace. * Previous pelvic or abdominal radiotherapy. * Previous total or partial hysterectomy. * Contra-indications to MRI. * Severe psychiatric condition. * Severe, active co-morbidity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| reproducibility of SBRT boost | Accuracy of treatment delivery will be measured during the 15 minutes of treatment delivery time | anatomical accuracy will be confirmed with image guided (CBCT) and online tracking will guarantee a limit of 2mm threshold |
| Adverse Events | through study completion, an average of 3 years | Treatment related side effects based on CTCAE V5.0 |
| Local control | through study completion, an average of 3 years | Free from loco-regional relapse |
| Dosimetric Feasibility of SBRT boost | through study completion, an average of 3 year | Fulfillment of protocol dosimetrical endpoints and constraints |
| Inter/intra fractional target motion | during the 15 minutes of treatment delivery time | 3D deviations recorded in CBCT images and electromagnetic recording |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distant Relapse | through study completion, an average of 3 years | Free from distant relapse |
| Quality of life metrics | through study completion, an average of 3 years | Change from baseline in European Organisation for Research and Treatment of Cancer quality of life questionnaire C30 |
Countries
Portugal
Contacts
Primary ContactMaria Inês Antunes, MD
Backup ContactCarlo Greco, MD
Outcome results
None listed