Clinical trial · Interventional
NAC Followed by RH for the Treatment of LACC
Neoadjuvant Chemotherapy Followed by Radical Hysterectomy for the Treatment of Locally Advanced Cervical Cancer: A Prospective Cohort Study
- 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 cohort study is to evaluate the role of neoadjuvant chemotherapy (NAC) in the treatment of locally advanced cervical cancer (LACC). Sixty patients with LACC (FIGO 2009 stage IB2 to IIB) will be enrolled. After informed consents, they would accept the imaging evaluation of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET). After excluding cases of distant metastasis, they will accept two cycles of NAC (paclitaxel 175 mg/m2 and cisplatin 70 mg/m2, on day 1, once for three weeks). Then a second MRI is performed to evaluate the imaging response. For patients achieving objective response, radical hysterectomy (RH, via laparoscopy or laparotomy) and an evaluation of pathologic response are performed. For patients without objective imaging response, the choice of concurrent chemoradiotherapy or radical hysterectomy will be discussed. After RH, adjuvant therapy will be given according to the RH pathologic results. The primary objectives consist of (1) the objective imaging response after NAC; (2) the objective pathologic response after RH. The secondary objectives consist of (1) disease-free survival and overall survival after various therapy modalities; (2) severe adverse effects of NAC; (3) the effects of NAC on the surgical outcomes.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adjuvant Therapy | — | UNRESOLVED | — |
| Concurrent Chemoradiotherapy | — | UNRESOLVED | — |
| Laparoscopy | — | UNRESOLVED | — |
| Laparotomy | — | UNRESOLVED | — |
| Locally Advanced Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Neoadjuvant Chemotherapy | — | UNRESOLVED | — |
| Objective Response | — | UNRESOLVED | — |
| Radical Hysterectomy | — | UNRESOLVED | — |
| Systematic Chemotherapy | — | UNRESOLVED |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| First imaging evaluation | Diagnostic Test | — | UNRESOLVED |
| Pathologic evaluation | Diagnostic Test | — | UNRESOLVED |
| Radiochemotherapy | Radiation | — | UNRESOLVED |
| RH | Procedure | — | UNRESOLVED |
| Second imaging evaluation | Diagnostic Test | — | UNRESOLVED |
| The third cycles of neoadjuvant chemotherapy | Drug | — | UNRESOLVED |
| Two cycles of neoadjuvant chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Group A
- description
- Patients in group A don't receive neoadjuvant chemotherapy
- interventionNames
- Diagnostic Test: First imaging evaluation
- Radiation: Radiochemotherapy
- type
- EXPERIMENTAL
- label
- Group B
- description
- Patients in group B receive neoadjuvant chemotherapy and achieve imaging response
- interventionNames
- Drug: Two cycles of neoadjuvant chemotherapy
- Diagnostic Test: First imaging evaluation
- Diagnostic Test: Second imaging evaluation
- Drug: The third cycles of neoadjuvant chemotherapy
- Procedure: RH
- Diagnostic Test: Pathologic evaluation
- type
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix * FIGO stage IB2 to IIB * Type II or III radical hysterectomy or trachelectomy * Performance status of Eastern Cooperative Oncology Group (ECOG) 0-1 * Aged 18 years to 45 years * Well cardiopulmonary, liver and kidney functions for neoadjuvant chemotherapy * Signed an approved informed consents Exclusion Criteria: * Not satisfying any of the inclusion criteria
References
Publications (0)
Data not yet available