Clinical trial · Interventional
Study of Neoadjuvant Chemotherapy Versus Definite Concurrent Chemoradiotherapy for Locally Advanced Bulk Cervical Cancer
Phase III Randomized Prospective Clinical Study of Neoadjuvant Chemotherapy With Gemcitabine and Cisplatin(GP) Versus Definite Cisplatin Combined Weekly Chemoradiotherapy for Locally Advanced Bulk Cervical Cancer
NCT05189028CI-TRIAL-00073646unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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 phase III randomized prospective clinical study was conducted to compare the short-term and long-term outcomes of gemcitabine and cisplatin neoadjuvant chemotherapy versus definite cisplatin weekly concurrent chemoradiotherapy in patients with locally advanced bulk cervical cancer.
Conditions
Conditions (2)
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 |
| Neoadjuvant Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine and cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Locally advanced bulk cervical cancer neoadjuvant chemotherapy group(NACT)
- description
- Radiation: Radiotherapy with IMRT/VMAT+192Ir-HDR brachytherapy Radiotherapy: 46Gy/23F to external pelvic radiotherapy and 14Gy/7F boost to imaging diagnosis of positive lymph nodes 192Ir-HDR brachytherapy:A Point dose 6Gy\*4-6F Drug: gemcitabine plus cisplatin,cisplatin Neoadjuvant chemotherapy:gemcitabine and cisplatin (GP) regimen\*2 cycles Concurrent Chemotherapy: Weekly cisplatin chemotherapy ≥5 cycles
- interventionNames
- Drug: gemcitabine and cisplatin
- type
- ACTIVE_COMPARATOR
- label
- Locally advanced bulk cervical cancer chemoradiotherapy group(CCRT)
- description
- Radiation: Radiotherapy with IMRT/VMAT+192Ir-HDR brachytherapy Radiotherapy: 46Gy/23F to external pelvic radiotherapy and 14Gy/7F boost to imaging diagnosis of positive lymph nodes 192Ir-HDR brachytherapy:APoint A dose 6Gy\*4-6F Drug: cisplatin Concurrent Chemotherapy: Weekly cisplatin chemotherapy ≥5 cycles
- interventionNames
- Drug: gemcitabine and cisplatin
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic proof of primary cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma. * According to the 2018 International Federation of Cervical Cancer Obstetrics and Gynecology (FIGO) staging standard, the patient was diagnosed with local tumor ≥4cm in stage IB3, IIA2, IIB-IVA by at least one expert with associate high degree or above in the department of gynecology and gynecology. * Age≥18 \& ≤70. * ECOG score 0-2. * WBC ≥4.0×109/L, hemoglobin ≥60g/L, platelet ≥100.0×109/L; Serum bilirubin ≤ upper limit of normal, ALT, AST, ALP ≤ upper limit of normal ×2.5; Urea nitrogen (BUN) ≤ upper limit of normal ×1.5, creatinine (Cr)≤ upper limit of normal ×1.5. * Patients with prior malignancy are eligible if disease-free ≥ 5 years. * Signed study-specific informed consent form prior to study entry. Exclusion Criteria: * Line has anti-tumor treatment, including chemotherapy, radiotherapy, surgery). * Stage Ia1- IB2 and IVB cervical cancer. * Patients with uncontrolled serious medical or mental illnesses. * Women in pregnancy or lactation. * Psychological, family, social factors, such as lead to no informed consent. * Into the group of the first five years in addition to the cervical cancer merger other patients with a history of malignant tumor.
References
Publications (0)
Data not yet available
No reference posted for this study.