Clinical trial · Interventional
Neoadjuvant Chemotherapy With Carboplatin and Docetaxel in Patients With Advanced Ovarian Cancer-Prospective, Randomized Phase II Clinical Trial
Prospective, Randomized Phase II Clinical Trial to Select Primary Chemotherapy With Carboplatin and Docetaxel in Patients With Advanced Ovarian Cancer Stage FIGO IIIC and IV
- 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)
The purpose of this study is to evaluate response to neoadjuvant chemotherapy by imaging and observation of anatomical and biological indicators (i.e. ascites or continuous measurement of tumor marker CA 125). Furthermore the optimal number of preoperative administered cycles of combination chemotherapy with carboplatin and docetaxel should be determined.
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 |
|---|---|---|---|
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| neoadjuvant chemotherapy (Carboplatin/Docetaxel) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A1
- description
- 3 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 3 cycles of Carboplatin/Docetaxel (3-weekly) postoperative
- interventionNames
- Procedure: neoadjuvant chemotherapy (Carboplatin/Docetaxel)
- type
- EXPERIMENTAL
- label
- A2
- description
- 2 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 4 cycles of Carboplatin/Docetaxel (3-weekly) postoperative
- interventionNames
- Procedure: neoadjuvant chemotherapy (Carboplatin/Docetaxel)
Primary outcomes (1)
- measure
- Preoperative reduction of ascites volume
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histological confirmed ovarian neoplasm * Figo stage IIIC (2cm extrapelvic disease) or Figo IV * more than 500 ml ascites volume (measured by sonography) * age \> 18 years old * ECOG \<= 2 * adequate hepatological, renal and haematological function * informed consent Exclusion Criteria: * concomitant or previous malignant diseases * debulking procedures on initial surgical approach * existing peripheral sensoric neuropathy \>= grade 2 * acute infections * mental disorders, cerebral metastasis * bowel obstruction
References
Publications (2)
- DERIVEDPolcher M, Rudlowski C, Friedrichs N, Mielich M, Holler T, Wolfgarten M, Kubler K, Buttner R, Kuhn W, Braun M. In vivo intratumor angiogenic treatment effects during taxane-based neoadjuvant chemotherapy of ovarian cancer. BMC Cancer. 2010 Apr 13;10:137. doi: 10.1186/1471-2407-10-137. PMID 20388201
- DERIVEDPolcher M, Braun M, Friedrichs N, Rudlowski C, Bercht E, Fimmers R, Sauerwald A, Keyver-Paik MD, Kubler K, Buttner R, Kuhn WC, Hernando JJ. Foxp3(+) cell infiltration and granzyme B(+)/Foxp3(+) cell ratio are associated with outcome in neoadjuvant chemotherapy-treated ovarian carcinoma. Cancer Immunol Immunother. 2010 Jun;59(6):909-19. doi: 10.1007/s00262-010-0817-1. Epub 2010 Jan 20. PMID 20087581