VIBE - Virtual Image Guided Brachytherapy Emulation for Locally Advanced Cervical Cancer (LACC)

Trial Title: VIBE - Virtual Image Guided Brachytherapy Emulation for Locally Advanced Cervical Cancer (LACC)

NCT ID: NCT06394297

Condition: Cervical Cancer

Conditions: Official terms:
Uterine Cervical Neoplasms

Conditions: Keywords:
cervical cancer
Stereotactic body radiotherapy (SBRT)
Stereotactic ablative body radiotherapy (SABR)
Brachytherapy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

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

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: SBRT
Description: SBRT to reproduce HDR BT dose distribution in non-operated patients LACC
Arm group label: SBRT for cervical cancer

Other name: SABR

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.

Criteria for 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.

Gender: Female

Gender based: Yes

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Champalimaud Foundation

Address:
City: Lisboa
Zip: 1400-038
Country: Portugal

Status: Recruiting

Contact:
Last name: Manuela Seixas

Phone: +351 9675289072
Email: manuela.seixas@fundacaochampalimaud.pt

Investigator:
Last name: Maria Inês Antunes, MD
Email: Principal Investigator

Start date: August 4, 2023

Completion date: August 4, 2026

Lead sponsor:
Agency: Fundacao Champalimaud
Agency class: Other

Source: Fundacao Champalimaud

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06394297