Clinical trial · Interventional
Definitive Hypofractionated Intensity-modulated Radiation Theraphy With Concurrent Chemotherapy in Cervical Cancer
Definitive Hypofractionated Intensity-modulated Radiation Theraphy With Concurrent Chemotherapy in Cervical Cancer: A Prospective Phase II Trial (DEHIM_CCRT Trial)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| concurrent chemotherapy | Drug | — | UNRESOLVED |
| Definitive hypofractionated intensity-modulated radiation theraphy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Definitive hypofractionated intensity-modulated radiation theraphy with concurrent chemotherapy
- interventionNames
- Radiation: Definitive hypofractionated intensity-modulated radiation theraphy
- Drug: concurrent chemotherapy
Primary outcomes (1)
- measure
- Tumor Volume Redution Rate (TVRR) at 1 month after completion of treatment based on MRI
- timeFrame
- 1 month after completion of treatment
Secondary outcomes (4)
- measure
- 3 years local recurrence
- timeFrame
- 3 years after treatment initiation
- measure
- 3 years progression-free survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available