oligometastatic breast cancer
Conditions
Interventions
Trade Name: Taxol 6mg/ml
Product Name: Taxol
Product Code: Paclitaxel
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Paclitaxel
Current Sponsor code: Paclitaxel
Concentration unit: mg
Sponsors
Martin-Luther-University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - women with histologically or cytologically confirmed, oligometastatic breast cancer (stage IV), defined as either =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - patients with cerebral metastases, as well as metastases in anatomic proximity to peripheral nerves procluding the delivery of the planned radiochemotherapy - malignant ascites, pericardial or pleural effusions - uncontrolled concommitant malignancy - pregnant or lactating women - prior radiation to the metastatic sites - prior treatment with taxanes - known hypersensitivity to taxanes or Cremophor EL - patients with a history of grade III/IV peripheral neuropathy of any etiology - patients with diabetes mellitus and a peripheral neuropathy > grade I
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Phase I: Maximum tolerated dose of local 3DCRT to metastatic sites in the proposed combined medality treatment Phase II: Progression-free-survival in both study arms, as measured by the one-year progression-free survival rate;Main Objective: Phase I: To determine the maximum tolerated dose of local 3D conformal radiotherapy (3DCRT) to the metastatic sites for combined modality treatment with systemic paclitaxel weekly chemotherapy (80mg/m2), followed by systemic chemotherapy with paclitaxel weekly until a total of 8 weeks, in patients with oligometastatic breast cancer Phase II: To determine the effect of systemic paclitaxel weekly chemotherapy - with or without local 3DCRT to metastatic sites - on progression-free survival, as measured by the one-year progression-free survival rate in patients with oligometastatic brast cancer;Secondary Objective: Phase I: To determine: - progression-free survival, as measured by the 9-month progression-free survival rate To describe: - objective tumor response rate (ORR), ccording to RECIST-Criteria - time to progression, as measured by the 1-, 2-, and 3-year progression-free-survival rates - toxicity - overall survival Phase II: To determine: - progression-free survival, as measured by the 9-month progression-free survival rate To describe -time-to-progression, as measured by the 2- and 3-year progression-free-survival rates -toxicity -overall survival of combined systemic paclitaxel weekly chemotherapy, with or without local 3DCRT, followed by systemic paclitaxel weekly chemotherapy, in patients with oligometastatic breast cancer | — |
Countries
Germany
Outcome results
None listed