Integration of 3D-conformal, local radiotherapy (3DCRT) to metastatic sites in a paclitaxel weekly chemotherapy regimen in oligometastatic breast cancer patients: A phase I- and randomised phase II-study

ISRCTN	ISRCTN97281381
DOI	https://doi.org/10.1186/ISRCTN97281381
Protocol serial number	KKSH-14
Sponsor	Martin-Luther-University (Germany)
Funder	German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung) (BMBF) (grant no. 01ZP0301/G)

Submission date: 01/06/2005
Registration date: 05/07/2005
Last edited: 12/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Anna D. Wagner
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Integration of 3D-conformal, local radiotherapy (3DCRT) to metastatic sites in a paclitaxel weekly chemotherapy regimen in oligometastatic breast cancer patients: A phase I- and randomised phase II-study
Study acronym	PACLITAXEL-3DCRT
Study objectives	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(s)	No ethics information provided at time of registration.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Progression-free-survival in both study arms, as measured by the one-year progression free survival rate
Key secondary outcome measure(s)	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
Completion date	01/10/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	80
Key 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
Key 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
Date of first enrolment	01/10/2005
Date of final enrolment	01/10/2011

Locations

Countries of recruitment

Germany

Study participating centre

Koordinationszentrum für Klinische Studien

Halle/Saale
06120
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Editorial Notes

12/01/2021: The EudraCT number has been added.