Breast CancerPhase 2NCT00006256
Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer
A Phase 2 study testing paclitaxel, adjuvant therapy and radiation therapy in people with Breast Cancer, run by Case Comprehensive Cancer Center at 9 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining paclitaxel with radiation therapy may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- paclitaxel, adjuvant therapy and radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 44 participants
- Where
- 9 sitesUnited States
- Study dates
- 8 Jun 2000to 20 Nov 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Stage II or III invasive breast cancer
- Prior breast conserving surgery (lumpectomy or quadrantectomy) with ipsilateral axillary lymph node dissection required
- No prior contralateral breast cancer
- No metastatic disease
- Prior ductal carcinoma in situ or lobular carcinoma in situ of the breast allowed unless treated with radiation or chemotherapy
- Doxorubicin and cyclophosphamide adjuvant chemotherapy completed within past 3 weeks
- Candidate for definitive radiotherapy
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm3
- Granulocyte count at least 2,000/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- ALT/AST no greater than 1.5 times ULN
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- No concurrent poorly controlled ischemic heart disease or congestive heart failure
- LVEF at least 45% by MUGA scan or echocardiogram
Pulmonary:
- No concurrent severe chronic obstructive or restrictive pulmonary disease
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No concurrent severe medical or psychiatric illness
- No concurrent severe diabetes mellitus
- No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix treated with local excision
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent filgrastim (G-CSF)
Chemotherapy:
- See Disease Characteristics
- Prior tamoxifen allowed
- No concurrent tamoxifen
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiation to the breast
Surgery:
- Recovered form prior surgery
Other:
- No concurrent adjuvant therapy on another clinical trial
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
UH-CantonMercy
Canton, Ohio, 44708
UH-Geauga
Chardon, Ohio, 44024
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5055
UH-Monarch
Mayfield Heights, Ohio, 44124
UH-LUICC
Mentor, Ohio, 44060
UH-Southwest
Middleburg Heights, Ohio, 44130
UH-Chagrin Highlands
Orange, Ohio, 44122
UH-Green Road
South Euclid, Ohio, 44121
UH-Westlake
Westlake, Ohio, 44145
About this study
Official title: Concurrent Taxol (Paclitaxel) and Definitive Breast Radiation Therapy in Early Stage Breast Cancer Following Four Cycles of Adriamycin/Cytoxan Chemotherapy
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining paclitaxel with radiation therapy may kill more tumor cells.
PURPOSE: This trial is to study the effectiveness of concurrent administration of chemotherapy and radiation therapy in treating women who have stage II or stage III breast cancer by examining the complications and cosmetic effects.
Read the detailed description
OBJECTIVES:
- Determine the feasibility of concurrent paclitaxel and breast radiotherapy in women with stage II or III breast cancer who have had primary breast conserving surgery and adjuvant chemotherapy.
- Assess the cosmetic results of breast conservation after this treatment in these patients.
- Determine the pulmonary toxicity of this regimen in these patients.
OUTLINE: Patients receive paclitaxel IV over 3 hours every 21 days for 4 courses beginning 3 weeks after completion of the last doxorubicin and cyclophosphamide adjuvant regimen. Patients also undergo concurrent radiotherapy 5 days a week for approximately 6-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 month, every 3 months for 1 year, every 6 months for the next 5 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study over 12-18 months.
- Conditions
- Breast Cancer
- Being tested
- paclitaxel, adjuvant therapy, radiation therapy
- Keywords
- stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxelDrug
Patients receive paclitaxel IV over 3 hours every 21 days for 4 courses beginning 3 weeks after completion of the last doxorubicin and cyclophosphamide adjuvant regimen.
adjuvant therapyProcedure or surgery
doxorubicin and cyclophosphamide adjuvant regimen
radiation therapyRadiation
Patients also undergo concurrent radiotherapy 5 days a week for approximately 6-7 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the feasibility of concurrent paclitaxel and breast radiotherapy
Ability to deliver appropriate doses of radiation therapy within the appropriate time course
Measured: Followed every 3 months for 1 year
chemotherapy dose achieved during concurrent Taxol and radiation therapy.
Measured: Followed every 3 months for 1 year
Secondary outcomes (3)
Cosmetic outcome based upon established descriptive parameters: excellent, good, fair, and poor.
These parameters will be assessed by medical and radiation oncology. We expect at least a > 60% completion rate with this treatment, which translates into confidence limits of 46% to 74% when 40 patients are investigated.
Measured: 1 year
Pulmonary function
Combined treatment impact on pulmonary function. Evidence of pulmonary toxicity demonstrated by a reduction in DLCO (Diffusing Capacity of the Lung for Carbon Monoxide).
Measured: 1 year
Survival
Patients followed for long term survival for at least 5 years.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study start8 Jun 2000
- Primary completion30 Nov 2005
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janice Lyons, MD, Study chair, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006256
- Sponsor's protocol ID
- CWRU2199
- Status last verified
- Nov 2023
- First submitted
- 11 Sep 2000
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Taxol (Paclitaxel) and Definitive Breast Radiation Therapy in Early Stage Breast Cancer Following Four Cycles of Adriamycin/Cytoxan Chemotherapy
- ClinicalTrials.gov ID
- NCT00006256
- Acronym / sponsor ID
- CWRU2199
- Conditions
- Breast Cancer
- Keywords
- stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 8 Jun 2000 (actual)
- Primary completion
- 30 Nov 2005 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining paclitaxel with radiation therapy may kill more tumor cells.
PURPOSE: This trial is to study the effectiveness of concurrent administration of chemotherapy and radiation therapy in treating women who have stage II or stage III breast cancer by examining the complications and cosmetic effects.
Detailed description
OBJECTIVES:
- Determine the feasibility of concurrent paclitaxel and breast radiotherapy in women with stage II or III breast cancer who have had primary breast conserving surgery and adjuvant chemotherapy.
- Assess the cosmetic results of breast conservation after this treatment in these patients.
- Determine the pulmonary toxicity of this regimen in these patients.
OUTLINE: Patients receive paclitaxel IV over 3 hours every 21 days for 4 courses beginning 3 weeks after completion of the last doxorubicin and cyclophosphamide adjuvant regimen. Patients also undergo concurrent radiotherapy 5 days a week for approximately 6-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 month, every 3 months for 1 year, every 6 months for the next 5 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study over 12-18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paclitaxelPatients receive paclitaxel IV over 3 hours every 21 days for 4 courses beginning 3 weeks after completion of the last doxorubicin and cyclophosphamide adjuvant regimen. | Drug | – |
| adjuvant therapydoxorubicin and cyclophosphamide adjuvant regimen | Procedure or surgery | – |
| radiation therapyPatients also undergo concurrent radiotherapy 5 days a week for approximately 6-7 weeks. | Radiation | – |
Primary outcome
Determine the feasibility of concurrent paclitaxel and breast radiotherapy
Time frame: Followed every 3 months for 1 year
Ability to deliver appropriate doses of radiation therapy within the appropriate time course
chemotherapy dose achieved during concurrent Taxol and radiation therapy.
Time frame: Followed every 3 months for 1 year
3 secondary outcomes
Cosmetic outcome based upon established descriptive parameters: excellent, good, fair, and poor.
Time frame: 1 year
Pulmonary function
Time frame: 1 year
Survival
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice Lyons, MD study chair
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing paclitaxel, adjuvant therapy and radiation therapy in people with Breast Cancer, run by Case Comprehensive Cancer Center at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the feasibility of concurrent paclitaxel and breast radiotherapy (time frame: Followed every 3 months for 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.