Clinical trial · Interventional
Neoadjuvant Chemotherapy + Surgery Versus Surgery in FIGO IB2 and IIA2 Cervical Cancer
A Trial of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery in FIGO IB2 and IIA2 Cervical Cancer(CSEM005)
NCT02629718CI-TRIAL-00032105SYSGO-003unknownPhase 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)
To clarify the potential benefits of NACT before radical surgery(RS), we perform a phase III, randomised controlled trial to compare NACT plus RS with RS alone in patients with stages IB2 and IIA2 cervical cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| OS | — | UNRESOLVED | — |
| PFS | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NACT (Paclitaxel + Cisplatin or carboplatin) | Drug | — | UNRESOLVED |
| radical surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A(NACT)
- description
- Neoadjuvant Chemotherapy followed by Radical Surgery
- interventionNames
- Drug: NACT (Paclitaxel + Cisplatin or carboplatin)
- Procedure: radical surgery
- type
- ACTIVE_COMPARATOR
- label
- B(RS)
- description
- Radical Surgery alone
- interventionNames
- Procedure: radical surgery
Primary outcomes (1)
- measure
- Disease free survival
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with newly histologically confirmed cervical carcinoma; * Histopathology squamaous carcinoma, adenocarcinoma or adeno-squamous carcinoma; * Original clinical stage must be IB2 or IIA2 （FIGO); * Age between 18-65; * Patients must give signed informed consent; * P.S status: 0-1; * Estimated survival time \> 3 months; 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/mm; * Accompany with other malignancy.
References
Publications (0)
Data not yet available
No reference posted for this study.