Clinical trial · Interventional
Neoadjuvant Chemotherapy and Radical Surgery in Stage IIB Cervical Cancer
Neoadjuvant Chemotherapy and Radical Surgery Versus Concurrent Chemoirradiation in FIGO Stage IIB Cervical Cancer
NCT02595554CI-TRIAL-00025782SYSGO002unknownPhase 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)
Neoadjuvant chemotherapy (NACT) and radical surgery (RS) may have a possible better outcome to concurrent chemoirradiation (CCRT) in stage IIB cervical cancer. We try to verify such a hypothesis in terms of survival and treatment related morbidity.
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 Carcinoma Stage IIB | Cervical Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Concurrent chemoirradiation | Radiation | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Radical Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Concurrent chemoirradiation (CCRT)
- description
- Concurrent chemoirradiation
- interventionNames
- Radiation: Concurrent chemoirradiation
- type
- EXPERIMENTAL
- label
- NACT+Surgery
- description
- Neoadjuvant chemotherapy with Paclitaxel and Cisplatin (3 cycles), followed by radical surgery
- interventionNames
- Drug: Paclitaxel
- Procedure: Radical Surgery
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Disease free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with newly histologically confirmed cervical carcinoma * Original clinical stage must be IIB （FIGO 2009） * Histopathology squamous carcinoma, adenocarcinoma or adeno-squamous carcinoma * Age between 18-65 * Patients must give signed informed consent Exclusion Criteria: * The presence of uncontrolled life-threatening illness * Receiving other ways of anti-cancer therapy * Investigator consider the patients can't finish the whole study * With normal liver function test (ALT、AST\>2.5×ULN) * With normal renal function test (Creatinine\>1.5×ULN) * WBC\<4,000/mm3 or PLT\<100,000/mm3
References
Publications (1)
- DERIVEDTu H, Huang H, Ouyang Y, Liu Q, Xian B, Song K, Chen G, Shen Y, Liu J. Neoadjuvant chemotherapy followed by radical surgery versus concurrent chemoradiotherapy in patients with FIGO stage IIB cervical cancer: the CSEM 006 study. Int J Gynecol Cancer. 2021 Jan;31(1):129-133. doi: 10.1136/ijgc-2020-001357. Epub 2020 Jun 9. PMID 32522771