Virtual Image Guided Brachytherapy for Locally Advanced Cervical Cancer
A Phase I/II Study for Image Guided Stereotactic Body Radiation Therapy Boost for Definitive Treatment of Locally Advanced Cervical Cancer (LACC)
This study is testing a new type of radiation treatment for women with locally advanced cervical cancer to see if it works as well and is as safe as the standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fundacao Champalimaud Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Lisbon) |
| Trial ID | NCT06394297 on ClinicalTrials.gov |
What this trial studies
This study evaluates the use of Stereotactic Body Radiotherapy (SBRT) to replicate the dose distribution of high dose rate brachytherapy in patients with locally advanced cervical cancer. It is a phase I/II feasibility study that employs advanced imaging techniques and real-time tracking to ensure accurate treatment delivery. Eligible patients will receive four sessions of image-guided SBRT following whole pelvis external beam radiotherapy, with follow-up assessments to monitor outcomes and toxicity. The goal is to determine the effectiveness and safety of this approach compared to traditional brachytherapy.
Who should consider this trial
Good fit: Ideal candidates are patients with biopsy-proven locally advanced cervical cancer suitable for curative treatment with definitive radio-chemotherapy.
Not a fit: Patients with metastatic disease beyond the retroperitoneal paraaortic L1-L2 interspace or those with previous pelvic or abdominal radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive and more precise treatment option for patients with locally advanced cervical cancer.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using advanced radiotherapy techniques for cancer treatment, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lisbon
- Champalimaud Foundation — Lisbon, Portugal (Recruiting)
Study contacts
- Study coordinator: Maria Inês Antunes, MD
- Email: ines.antunes@fundacaochampalimaud.pt
- Phone: +351210480200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.