Status:
COMPLETED
Accelerated Radiation Therapy After Surgery in Treating Patients With Breast Cancer
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Conditions:
Inflammatory Breast Cancer
Invasive Ductal Breast Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies how well giving accelerated radiation therapy (RT) after surgery works in treating patients with breast cancer. RT uses high energy x rays to kill tumor cells. Giving RT af...
Detailed Description
PRIMARY OBJECTIVES: I. Freedom from local failure and freedom from regional failure. SECONDARY OBJECTIVES: I. Acute toxicity and late toxicity using previously published toxicity scales. II. To ide...
Eligibility Criteria
Inclusion
- Invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies; invasive lobular carcinomas are allowed
- American Joint Committee for Cancer (AJCC) Stage IIa - IIIc (pathologic stage T0N1-3, T1N1-3, T2N1-3, T3N0-3, T4N0-3, all M0 status) histologically confirmed invasive carcinoma of the breast treated with mastectomy and either sentinel node biopsy or axillary dissection; inflammatory carcinoma (T4d) is allowed
- Patients with locally advanced breast cancer on clinical exam and diagnostics ( \> 3 cm and/or clinically node-positive) who have mastectomy after induction chemotherapy are allowed
- Multifocal/multicentric disease is allowed
- Negative inked histologic margins of mastectomy (no invasive cells at margin) or positive margin at pectoralis fascia or skin
- Tamoxifen, Arimidex or other hormonal therapy is allowed; it may begin any time relative to the radiation at the discretion of the treating physician
- Chemotherapy is allowed, if chemotherapy is indicated the chemotherapy can be delivered first, followed by radiation therapy beginning 21-63 days after the last cycle of chemotherapy or the radiation therapy can be delivered first and the chemotherapy can be delivered no earlier than 21 days post radiation therapy; neoadjuvant chemotherapy is allowed; radiation therapy will be delivered after mastectomy or after any adjuvant chemotherapy as described above
- Chest wall reconstruction is allowed
- The patient must be enrolled and have treatment planning between 14-63 days from date of last surgery or last cycle of chemotherapy, and radiation must start within 21-63 days of date of last surgery or last cycle of chemotherapy
- Signed study-specific informed consent form prior to study entry
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion
- Patient with distant metastases (M1)
- Patients with ductal or lobular carcinoma in-situ alone (no invasive component) and patients with non-epithelial breast malignancies such as sarcoma or lymphoma
- Patient with T1N0 or T2N0 disease
- Prior radiation therapy to the chest
- Patients with collagen vascular diseases, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
- Patients with co-existing medical conditions with life expectancy \< 2 years
- Patients with psychiatric (with the possible exception of incompetence as defined by New Jersey \[NJ\] law) or addictive disorders that would preclude obtaining informed consent
- Other malignancy, except non-melanomatous skin cancer, \< 5 years prior to participation in this study; the disease-free interval from any prior carcinoma must be continuous
- Women who are pregnant or lactating due to potential exposure of the fetus to RT and unknown effects of RT to lactating females
- Women who are able to conceive and unwilling to practice an effective method of birth control; women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to treatment
Key Trial Info
Start Date :
December 21 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2020
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT01417286
Start Date
December 21 2010
End Date
February 20 2020
Last Update
April 20 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
2
Huntsman Cancer Hospital
Salt Lake City, Utah, United States, 84103