Definitive Hypofractionated Intensity-modulated Radiation Theraphy With Concurrent Chemotherapy in Cervical Cancer

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.

Eligibility

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

Conditions2

Interventions1

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