New injection plus radiation shows promise against cervical cancer

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Provide written informed consent before participation. * Female subjects age 18 years or older. * Histologically diagnosed squamous cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix. * FIGO stage II and III locally advanced cervical cancer. * No evidence of metastatic disease. * At least one tumor that qualifies as a Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 tumor with tumor size \>5 cm diameter, not previously irradiated, at baseline assessed \[by magnetic resonance imaging (MRI)\] within 28 days before Day 1. * No prior chemotherapy or radiotherapy for cervical cancer. * Intention to undergo treatment including EBRT with 5 cycles of cisplatin followed by BT; to be completed within 8 weeks of its initiation. * Patients with predicted life expectancy of 3 months or more. * Target tumor is accessible for intratumoral injection. * Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1. * Negative pregnancy test before start of CRT in women of childbearing potential and an ability/willingness to protect against pregnancy from consent and for 3 months post-RT. Exclusion Criteria: * Other primary malignancies except basal cell carcinoma of the skin. * Histologically diagnosed small cell (neuroendocrine), melanoma, clear cell and other rare variants of the classical adenocarcinoma at cervices. * Previous pelvic or abdominal radiotherapy. * Previous total or partial hysterectomy. * Combination of preoperative radiotherapy with surgery. * Patients receiving neo-adjuvant chemotherapy or non-protocol antineoplastic treatment apart from weekly cisplatin (40 mg/m2). * Anatomical location and/or extent of disease difficult to access for safe intratumoral drug injections. * Contraindications to the pelvic radiation such as inflammatory bowel disease and collagen vascular disease. * Contraindications to MRI. * Patients on anticoagulants or deranged coagulation profile. * Pregnancy or nursing. * High medical risks because of non-malignant systemic disease or with active uncontrolled infection. * Participation in another clinical trial with an investigational drug, device or biologic within the preceding 3 months, except an observational study.