Clinical trial NCT01417286: Accelerated Radiation Therapy After Surgery in Treating Patients With Breast Cancer
Official title: Accelerated, Hypofractionated Post-Mastectomy Radiation Therapy in Women With Breast Cancer: A Phase II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Inflammatory Breast Cancer
Invasive Ductal Breast Carcinoma
Invasive Lobular Breast Carcinoma
Mucinous Ductal Breast Carcinoma
Papillary Ductal Breast Carcinoma
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Tubular Ductal Breast Carcinoma
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Rutgers Cancer Institute of New Jersey
First posted: 2011-08-16
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 after surgery may kill any remaining tumor cells

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 identify co-variates responsible for poor cosmetic outcome in women with reconstructed chest walls when treated with accelerated, hypofractionated radiotherapy.

III. To correlate toxicity, cosmesis, and local control with molecular markers.

OUTLINE:

Patients undergo hypofractionated accelerated RT over 11 weekdays (for 15 elapsed days) within 21-63 days after last surgery or last course of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 2-8 weeks, every 3-6 months for 3 years, every 6-12 months for 2 years, and then annually thereafter.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Number of Participants With Local, Regional, and/or Distant Failure
timeFrame: Up to 5 years after dose of last treatment, an average of 62 months
Secondary outcomes:
measure: Count of Participants With Grade Three or Higher Toxicities
timeFrame: weekly during treatment, then two weeks after RT, then at week 8, then every 3-6 months for 3 years, then every 6-12 months out to 5 years.
measure: Participants With Plans for Breast Reconstruction, Having Grade Three or Higher Reconstruction Complications
timeFrame: Up to five years after dose of last treatment, an average of 62 months
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Salt Lake City
country: United States
facility: Huntsman Cancer Hospital
state: Utah
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Bruce Haffty, MD
role: PRINCIPAL_INVESTIGATOR
References: