Advanced treatment for locally advanced cervical cancer using image-guided techniques

Image Guided Intensity Modulated External Beam Radiochemotherapy and MRI Based Adaptive BRAchytherapy in Locally Advanced CErvical Cancer

This study is testing a new way to treat locally advanced cervical cancer using advanced imaging techniques to improve tumor control and reduce side effects for patients.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Ages: 18 Years to 99 Years
• Sex: Female
• Sponsor: Medical University of Vienna (other)
• Drugs / interventions: chemotherapy, Radiation
• Locations: 1 site (Vienna)
• Trial ID: NCT03617133 on ClinicalTrials.gov

What this trial studies

This study focuses on improving the treatment of locally advanced cervical cancer through the use of image-guided adaptive brachytherapy (IGABT) combined with radiochemotherapy. It aims to enhance local tumor control and minimize adverse reactions to surrounding organs by employing advanced imaging techniques and treatment protocols. The study builds on previous findings from the EMBRACE study and incorporates state-of-the-art methods in tele- and brachytherapy. Participants will receive comprehensive imaging assessments and tailored treatment plans to optimize their care.

Who should consider this trial

Good fit: Ideal candidates include patients with locally advanced cervical cancer who are suitable for curative treatment with definitive radio-(chemo)therapy and have specific histological types of cervical carcinoma.

Not a fit: Patients with metastatic disease beyond the retroperitoneal para-aortic 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 significantly improve treatment outcomes and quality of life for patients with locally advanced cervical cancer.

How similar studies have performed: Previous studies, including the EMBRACE and RetroEMBRACE studies, have shown promising results with similar image-guided approaches in treating cervical cancer.

Eligibility criteria

Inclusion Criteria:

* Cancer of the uterine cervix considered suitable for curative treatment with definitive radio-(chemo)therapy including MRI guided BT
* Positive biopsy showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix.
* Staging according to FIGO and TNM guidelines
* MRI of pelvis at diagnosis is performed
* MRI, CT or PET-CT of the retroperitoneal space and abdomen at diagnosis is performed
* MRI with the applicator in place at the time of (first) BT will be performed
* Para-aortic metastatic nodes below L1-L2 are allowed
* 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 para-aortic L1-L2 interspace
* Previous pelvic or abdominal radiotherapy
* Previous total or partial hysterectomy
* Combination of preoperative radiotherapy with surgery
* Patients receiving BT only
* Patients receiving EBRT only
* Patients receiving neo-adjuvant chemotherapy or other forms of antineoplastic treatment apart from weekly concomitant cisplatin (40 mg/2). However, adjuvant chemotherapy in the form of 4 courses of 3 weekly Carboplatin (AUC 5) and Paclitaxel (155 mg/m2) is allowed according to departmental policy.
* Contra indications to MRI
* Contra indications to BT

Where this trial is running

Vienna

• Medical University of Vienna — Vienna, Austria (RECRUITING)

Study contacts

• Principal investigator: Richard Pötter, MD — Medical University of Vienna
• Study coordinator: Richard Pötter, MD

Conditions: Uterine Cervical Neoplasms