Image Guided IMRT, Radiochemotherapy and MRI-based IGABT in Locally Advanced Cervical Cancer

Launched by MEDICAL UNIVERSITY OF VIENNA · Aug 3, 2018

Keywords

ClinConnect Summary

The EMBRACE II study is a clinical trial aimed at improving treatment for women with locally advanced cervical cancer. This study is focusing on advanced techniques that combine imaging guidance with radiation therapy and chemotherapy to better control the cancer while reducing side effects. Researchers want to ensure that the treatment is not only effective at fighting the cancer but also helps maintain the quality of life for patients by minimizing damage to surrounding organs like the bladder and rectum.

To be eligible for this trial, participants must have a confirmed diagnosis of cervical cancer and be suitable for treatment with radiation therapy. Women aged 18 and older who have specific types of cervical cancer, such as squamous-cell carcinoma or adenocarcinoma, may qualify. Participants will undergo various imaging tests, including MRIs, to help guide their treatment. Throughout the study, they will receive care in a supportive environment where their health will be closely monitored. This trial is currently recruiting participants, and it represents an important step toward enhancing how cervical cancer is treated.

Gender

FEMALE

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