Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00006256
• Lead Sponsor: Case Comprehensive Cancer Center

Brief 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.

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 Timeline

• Study Start: 2000-06-08
• Study First Submitted: 2000-09-11
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2005-11-30
• Status Verified: 2023-11
• Study Completion: 2023-11-20
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Determine the feasibility of concurrent paclitaxel and breast radiotherapy	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.	Followed every 3 months for 1 year

Secondary Outcome Measures

Name	Time	Method
Cosmetic outcome based upon established descriptive parameters: excellent, good, fair, and poor.	1 year	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.
Survival	5 years	Patients followed for long term survival for at least 5 years.
Pulmonary function	1 year	Combined treatment impact on pulmonary function. Evidence of pulmonary toxicity demonstrated by a reduction in DLCO (Diffusing Capacity of the Lung for Carbon Monoxide).

Trial Locations

Locations (9)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States

UH-Geauga; 🇺🇸 Chardon, Ohio, United States

UH-Monarch; 🇺🇸 Mayfield Heights, Ohio, United States

UH-CantonMercy; 🇺🇸 Canton, Ohio, United States

UH-LUICC; 🇺🇸 Mentor, Ohio, United States

UH-Southwest; 🇺🇸 Middleburg Heights, Ohio, United States

UH-Chagrin Highlands; 🇺🇸 Orange Village, Ohio, United States

UH-Green Road; 🇺🇸 South Euclid, Ohio, United States

UH-Westlake; 🇺🇸 Westlake, Ohio, United States