Clinical trial NCT06394297: VIBE - Virtual Image Guided Brachytherapy Emulation for Locally Advanced Cervical Cancer (LACC)
Official title: A Phase I/II Study for Image Guided Stereotactic Body Radiation Therapy Boost for Definitive Treatment of Locally Advanced Cervical Cancer (LACC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
Keywords: cervical cancer
Stereotactic body radiotherapy (SBRT)
Stereotactic ablative body radiotherapy (SABR)
Brachytherapy
Lead sponsor: Fundacao Champalimaud
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dosimetric Feasibility of SBRT boost
timeFrame: through study completion, an average of 3 year
measure: reproducibility of SBRT boost
timeFrame: Accuracy of treatment delivery will be measured during the 15 minutes of treatment delivery time
measure: Inter/intra fractional target motion
timeFrame: during the 15 minutes of treatment delivery time
measure: Adverse Events
timeFrame: through study completion, an average of 3 years
measure: Local control
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
measure: Quality of life metrics
timeFrame: through study completion, an average of 3 years
measure: Quality of life metrics
timeFrame: through study completion, an average of 3 years
measure: Distant Relapse
timeFrame: through study completion, an average of 3 years
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Champalimaud Foundation
Study officials:
affiliation: Fundaçao Champalimaud
name: Carlo Greco, MD
role: STUDY_DIRECTOR
References: