Cervical Cancer
Conditions
Keywords
Cervical Cancer, Concurrent Chemoradiotherapy
Brief summary
This study aims to evaluate the efficacy and safety of hypofractionated intensity-modulated radiation therapy (IMRT) combined with concurrent chemotherapy in patients with cervical cancer. Conventional treatment usually requires 7-8 weeks, which increases the risk of toxicities and treatment delays. This trial seeks to shorten the overall treatment time while maintaining non-inferior tumor response and survival outcomes compared to standard therapy. The primary endpoint is tumor volume reduction rate (TVRR) assessed by pelvic MRI at 1 month after treatment. Secondary endpoints include 3-year local recurrence rate, progression-free survival, and incidence of acute and late grade ≥3 toxicities. The results of this study are expected to contribute to establishing an optimal treatment strategy for cervical cancer.
Detailed description
Patients receive weekly cisplatin at 40 mg/m² intravenously on days 1, 8, 15, 22, and 29, concurrently with external beam radiotherapy (EBRT). EBRT is delivered to the pelvic nodal regions at 1.8-2.0 Gy per fraction up to a total dose of 40-50 Gy. Sequential EBRT boost of 10-20 Gy to grossly positive nodal disease or 5-10 Gy to the parametrium may be applied if needed. The overall treatment course lasts approximately 7-8 weeks, and intracavitary brachytherapy (ICR) may be additionally performed when indicated.
Interventions
RADIATIONDefinitive hypofractionated intensity-modulated radiation theraphy
Patients receive weekly cisplatin at 40 mg/m² intravenously on days 1, 8, 15, 22, and 29, concurrently with external beam radiotherapy (EBRT). EBRT is delivered to the pelvic nodal regions at 1.8-2.0 Gy per fraction up to a total dose of 40-50 Gy. Sequential EBRT boost of 10-20 Gy to grossly positive nodal disease or 5-10 Gy to the parametrium may be applied if needed. The overall treatment course lasts approximately 7-8 weeks, and intracavitary brachytherapy (ICR) may be additionally performed when indicated.
DRUGconcurrent chemotherapy
Patients receive weekly cisplatin at 40 mg/m² intravenously on days 1, 8, 15, 22, and 29, concurrently with external beam radiotherapy (EBRT). EBRT is delivered to the pelvic nodal regions at 1.8-2.0 Gy per fraction up to a total dose of 40-50 Gy. Sequential EBRT boost of 10-20 Gy to grossly positive nodal disease or 5-10 Gy to the parametrium may be applied if needed. The overall treatment course lasts approximately 7-8 weeks, and intracavitary brachytherapy (ICR) may be additionally performed when indicated.
Sponsors
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) * FIGO stage IIB-IVA (2018) * Measurable primary tumor on pelvic MRI within 30 days prior to treatment initiation * Age ≥ 20 years * ECOG performance status 0-1 * Adequate bone marrow function: WBC ≥ 3,000/µL, ANC ≥ 1,000/µL, platelets ≥ 100,000/µL, hemoglobin ≥ 9 g/dL * Adequate renal function: Creatinine \< 2.0 mg/dL * Ability to provide written informed consent
Exclusion criteria
* Patients with distant metastasis * Patients who have previously received pelvic radiotherapy * Patients who have previously received definitive chemotherapy or chemoradiotherapy for diagnosed cervical cancer * Patients who have undergone surgery for the current cervical cancer lesion * Patients who underwent local excisional procedures of the cervix such as conization or Loop Electrosurgical Excision Procedure (LEEP) prior to radiotherapy * Patients who are unable to undergo concurrent chemoradiotherapy due to poor general condition * Patients with other active malignancies (except carcinoma in situ of the cervix, basal cell carcinoma of the skin, or superficial bladder cancer) within 3 years prior to enrollment or who experienced recurrence within 3 years after treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor Volume Redution Rate (TVRR) at 1 month after completion of treatment based on MRI | 1 month after completion of treatment |
Secondary
| Measure | Time frame |
|---|---|
| 3 years local recurrence | 3 years after treatment initiation |
| 3 years progression-free survival (PFS) | 3 years after treatment initiation |
| incidence of acute and late adverse events ≥ Grade 3 | During RT treatment to Post RT 3 years |
| Prognostic factor analysis for local recurrence and progression-free survival | 3 years after treatment initiation |
Countries
South Korea
Contacts
CONTACTwon park
Outcome results
None listed