Clinical trial · Interventional
Neo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertility
NCT03852979CI-TRIAL-00042697NEOCON-FterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): study is merged with CONTESSA study
Summary
Brief summary (as posted)
If no metastases are observed, patients will start a short protocol of four courses of weekly neo-adjuvant chemotherapy (12 weeks). If response to chemotherapy results in a tumor of less than 2 cm, cervical conisation will be performed.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| conisation | Procedure | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- neo-adjuvant chemotherapy
- description
- The patients are given weekly paclitaxel 80 mg/m2 + carboplatin AUC=2 (or AUC=6 per three weeks) during 12 weeks/4 courses followed by conization if tumor size is reduced to \<2 cm
- interventionNames
- Drug: Paclitaxel
- Drug: Carboplatin
- Procedure: conisation
Primary outcomes (2)
- measure
- efficacy of neo-adjuvant chemotherapy
- timeFrame
- week 6 of neoadjuvant treatment
- description
- efficacy of neo-adjuvant chemotherapy on tumor response
- measure
- safety of neo-adjuvant chemotherapy
- timeFrame
- 2 years after conisation
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Stage Ib1 cervical cancer measuring ≥2 - ≤4 cm on physical examination and imaging in any direction * Histologic type: squamous cell carcinoma (SCC), adeno cell carcinoma (ACC), adeno-squamous cell carcinoma (ASC) * Lymph vascular space invasion allowed (LVSI) * Age ≥18 years and ≤ 40 years * Wish to preserve fertility * Written and signed informed consent * Negative serum or urine pregnancy test within 14 days prior to registration, and an effective method of contraception must be used during treatment * MRI abdomen and pelvis, chest X-ray must be performed and negative for metastatic disease within 12 weeks of enrolment * No metastases on pelvic lymph node dissection * Laboratory values: serum creatinine \< 140 μmol/L; creatinine clearance \> 60 ml/min(Cockroft formula); white blood cell count \> 3.5 x 109/l; platelets \> 100 x 109 /l Exclusion Criteria: * Other high grade histologies like neuro-endocrine and clearcell carcinoma * FIGO stage Ia, Ib1\< 2 cm, Ib2, II, III and IV disease * Involvement of tumor in uterine corpus on MRI or hysteroscopy if performed * Evidence of metastatic disease on imagining (PET/CT/MRI) performed within 12 weeks of enrolment * other malignancy
References
Publications (0)
Data not yet available
No reference posted for this study.