Condition category
Cancer
Date applied
01/06/2005
Date assigned
05/07/2005
Last edited
05/10/2006
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anna D. Wagner

ORCID ID

Contact details

Koordinationszentrum für Klinische Studien
Martin-Luther-University
Weinbergweg 23
Halle/Saale
06120
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KKSH-14

Study information

Scientific title

Acronym

PACLITAXEL-3DCRT

Study hypothesis

Local 3D conformal radiotherapy to metastatic sites, provided in addition to systemic chemotherapy with paclitaxel weekly, improves progression-free-survival in patients with oligometastatic breast cancer

Ethics approval

No ethics information provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Metastatic breast cancer

Intervention

Chemotherapy with paclitaxel weekly in both groups with additional 3D conformal radiotherapy to metastatic sites in the experimental arm

Intervention type

Other

Phase

Phase I/II

Drug names

Primary outcome measures

Progression-free-survival in both study arms, as measured by the one-year progression free survival rate

Secondary outcome measures

1. Objective tumor response rate
2. Toxicity
3. Overall survival, as measured by 1-, 2-, and 3-year survival rates
4. Clinical benefit (defined as the proportion of patients with stable disease [SD] >24 weeks, complete response [CR] and partial response [PR])
5. Quality of life, as measured by European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires (QLQ) C30 and BR-23 in both study arms

Overall trial start date

01/10/2005

Overall trial end date

01/10/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women with histologically or cytologically confirmed, oligometastatic (stage IV) breast cancer, defined as: more than or equal to three metastatic lesions, or primary tumor and more than or equal to two metastatic lesions not amenable to curative surgery for medical or surgical reasons
2. Estrogen- and progesterone receptor negative status, hormone-refractory or rapid progressive disease
3. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) (except patients with metastatic lesions confided to the bones who may be included in case of non-measurable, but assessasble disease
4. Age 18 to 75 years, Performance Status (PS) zero to one
5. Adequate renal, hematological and hepatic function
6. Minimum estimated life expectancy three months
7. Written informed consent
8. Absence of any condition potentially hampering compliance with the study protocol and follow-up schedule

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

80 (phase II)

Participant exclusion criteria

1. Patients with cerebral metastasis as well as metastasis in anantomic proximity to peripherapy nerves precluding the delivery of the planned radiochemotherapy
2. Malignant ascites, pericardial or pleural effusions
3. Concomitant malignancy (except basal cell skin carcinoma and carcinoma in situ of the uterine cervix)
4. Pregnant or lactating women, unclear contraception
5. Prior radiation to the metastatic sites
6. Prior treatment with taxanes
7. Known hypersensitivity to taxanes or cremophor EL
8. Patients with a history of grade III/IV peripheral neuropathy of any aetiology
9. Patients with diabetes mellitus and a peripheral neuropathy of any etiology

Recruitment start date

01/10/2005

Recruitment end date

01/10/2011

Locations

Countries of recruitment

Germany

Trial participating centre

Koordinationszentrum für Klinische Studien
Halle/Saale
06120
Germany

Sponsor information

Organisation

Martin-Luther-University (Germany)

Sponsor details

Universitätsplatz 10
Halle/Saale
06108
Germany

Sponsor type

University/education

Website

http://www.verwaltung.uni-halle.de

Funders

Funder type

Government

Funder name

German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung) (BMBF) (grant no. 01ZP0301/G)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes