Intra-lesional Tumor Boost for Bulky Cervical Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age19-80
SponsorSeoul National University Bundang Hospital
About this trial
The goal of this clinical trial is to learn if adding a radiation boost (intra-lesional boost) works to treat patients with large-sized cervical cancer. It will also learn about the safety of this treatment. The main questions it aims to answer are:
* Does the extra radiation boost effectively reduce the tumor size before the internal radiation (brachytherapy) treatment begins? * What medical problems (side effects) do participants have when receiving this treatment?
Researchers will give this intra-lesional boost to all participants during their standard radiation therapy to see if it helps shrink the tumor more than usual.
Participants will:
* Receive radiation therapy to the pelvis with a targeted boost to the tumor for about 5 to 6 weeks * Visit the clinic daily for radiation treatment and regularly for checkups Have an MRI scan during the 4th or 5th week of treatment to measure the tumor size * Receive internal radiation therapy (brachytherapy) after finishing the external radiation * Visit the clinic for follow-up checkups and tests for up to 2 years
Eligibility criteria
Qualifiers
Patients with histologically confirmed squamous cell carcinoma of the cervix.
Patients with bulky primary tumor, defined as a tumor volume ≥ 60 cc OR a maximum diameter ≥ 6 cm.
Patients aged 19 to 80 years at the time of diagnosis.
Patients with an ECOG performance status of 0 to 2.
Disqualifiers
Diagnosis of other malignancies within 5 years prior to enrollment (Exceptions: carcinoma in situ of the breast and thyroid cancer).
Patients who are medically unfit for definitive concurrent chemoradiotherapy.
Patients who have received prior chemotherapy (neoadjuvant chemotherapy) before radiation therapy.
Patients with prior history of radiation therapy to the abdomen or pelvis.
Trial design
Treatments tested in this trial
- intra-lesional boost IMRT
- High Dose Rate Brachytherapy
Treatment groups
17 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov