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 |
| Secondary identifying numbers | KKSH-14 |
- 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
Scientific
Koordinationszentrum für Klinische Studien
Martin-Luther-University
Weinbergweg 23
Halle/Saale
06120
Germany
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/10/2005 |
| Completion date | 01/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 80 (phase II) |
| 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
06120
Germany
Sponsor information
Martin-Luther-University (Germany)
University/education
University/education
Universitätsplatz 10
Halle/Saale
06108
Germany
| Website | http://www.verwaltung.uni-halle.de |
|---|---|
"ROR" |
https://ror.org/05gqaka33 |
Funders
Funder type
Government
German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung) (BMBF) (grant no. 01ZP0301/G)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
12/01/2021: The EudraCT number has been added.
