NCT01668108

Brief Summary

The main purpose of this observational study with Paclitaxel is to determine the number of treatment cycles and the quantity of Paclitaxel onkovis needed therefore under the special circumstance of ambulant chemotherapy. onkovis aims an economical utilization of the chemotherapeutics.The provision with adapted packaging sizes as to decrease the excess quantity to be discarded follows also this objective. Secondary objectives are the survey of the side effects of Paclitaxel onkovis in comparison to Docetaxel. To this purpose, data regarding co medications and adverse events are also collected.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
770

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2012

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2012

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

July 16, 2018

Status Verified

July 1, 2018

Enrollment Period

5.8 years

First QC Date

August 15, 2012

Last Update Submit

July 13, 2018

Conditions

Carcinoma

Keywords

carcinomabreast cancernon-small cell lung cancerovarial cancerambulant chemotherapytreatment cyclesPaclitaxelPaclitaxel onkovisQuantity of PaclitaxelPackaging Sizes

Outcome Measures

Primary Outcomes (1)

  • the quantity of Paclitaxel onkovis needed pro treatment cycle

    Determine the quantity of Paclitaxel onkovis needed pro treatment cycle

    the time the participants will be followed depends on the number of treatment cycles; that means the time frame may extend up to 24 weeks (8 cycles).

Secondary Outcomes (1)

  • adverse events during and after treatment in comparison to Docetaxel onkovis

    up to 24 weeks (8 cycles)

Study Arms (1)

carcinoma, Paclitaxel onkovis (Paclitaxel)

treatment in mono- or combination therapy with Paclitaxel of breast-, non-small cell lung- and ovarial cancer.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients treated in practices, clinics, hospitals

You may qualify if:

  • Indication for Paclitaxel according to the SmPC and treating physician

You may not qualify if:

  • according to the Paclitaxel SmPC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Practice

Brandenburg, 14770, Germany

Location

Practice

Chemnitz, 09117, Germany

Location

Practice

Dresden, 01307, Germany

Location

Practice

Mühlhausen, 99974, Germany

Location

Practice

Plauen, 08525, Germany

Location

MeSH Terms

Conditions

CarcinomaBreast NeoplasmsCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2012

First Posted

August 17, 2012

Study Start

August 1, 2012

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

July 16, 2018

Record last verified: 2018-07

Locations

DE(5)