Cervical Cancer, Squamous Cell Carcinoma of Cervix
Conditions
Keywords
cervical cancer, bulky cervical cancer, squamous cell carcinoma, intra lesional boost, simultaneous integrated boost, imrt, radiotherapy, tumor volume reduction
Brief summary
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
Interventions
RADIATIONintra-lesional boost IMRT
Patients receive Whole Pelvis (+/- para-aortic field) radiotherapy 45-50.4 Gy in 25-28 fractions. An intra-lesional boost is delivered using SIB technique: 15 Gy in 3 fractions to the boost target (GTVp minus 0.7-1.0 cm margin).
PROCEDUREHigh Dose Rate Brachytherapy
Followed by CT or MRI-based HDR brachytherapy. Recommended dose is 27.5-30 Gy in 4-6 fractions to the HR-CTV using Iridium-192 source.
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Patients who have voluntarily agreed to participate in the study.
Exclusion criteria
* 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. * Patients unable to provide informed consent due to mental or physical disabilities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Tumor Volume < 12 cc Before Brachytherapy | At 4 to 5 weeks after the start of radiation therapy (specifically at the time of 20-25 fractions) | Tumor volume is measured using pelvic MRI volumetric analysis to determine if the intra-lesional boost successfully reduces the target volume below 12 cc. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Remission (CR) Rate | From treatment completion up to 2 years | Defined as the disappearance of all lesions on cervical examination and imaging tests. |
| Locoregional Control Rate | From treatment completion up to 2 years | Defined as the absence of tumor recurrence in the locoregional area confirmed by biopsy or imaging. |
| Progression-Free Survival (PFS) | From date of enrollment to progression or death, assessed up to 2 years | Assessed using the Kaplan-Meier method. |
| Overall Survival (OS) | From date of enrollment to death from any cause, assessed up to 2 years | Assessed using the Kaplan-Meier method. |
| Incidence of Treatment-Related Adverse Events | From the start of treatment up to 2 years | Assessed and graded according to NCI-CTCAE version 6.0. |
Countries
South Korea
Contacts
CONTACTKeun-Yong Eom, MD, PhD
Outcome results
None listed