3-Dimensional Conformal Radiation Therapy In Treating Women With Stage I or Stage II Breast Cancer Previously Treated With Lumpectomy and Axillary Node Dissection

Breast Cancer Clinical Trial

Official title:

A Phase I/II Trial to Evaluate Three Dimensional Conformal Radiation Therapy (3D-CRT) Confined to the Region of the Lumpectomy Cavity for Stage I and II Breast Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00068263
• Other study ID #: RTOG-0319
• Secondary ID: CDR0000316246
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 10, 2003
• Last updated: December 30, 2016
• Start date: August 2003
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Radiation Therapy Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: 3-dimensional conformal radiation therapy delivers a high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: Phase I/II trial to study the effectiveness of 3-dimensional conformal radiation therapy in treating women who have undergone lumpectomy and axillary node dissection for stage I or stage II breast cancer.

Description:

OBJECTIVES:

• Determine the technical feasibility and reproducibility of three-dimensional conformal radiotherapy confined to the region of the lumpectomy cavity in women with stage I or II breast cancer.

• Determine the cosmetic results in patients treated with this regimen.

• Determine the complication rates in patients treated with this regimen.

• Determine the local control rate in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo three-dimensional conformal radiotherapy twice daily for 5 days beginning within 8 weeks after surgery.

Patients are followed at 6 weeks, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 19-46 patients will be accrued for this study within 6.3 to 15.3 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive breast cancer

• Stage I or II (T1, N0; T1, N1; T2, N0; or T2, N1)

• Unifocal disease (single focus that can be encompassed by one lumpectomy)

• The following histologies are eligible:

• Invasive ductal

• Medullary

• Papillary

• Colloid (mucinous)

• Tubular

• No invasive or extensive in situ lobular carcinoma or pure ductal carcinoma in situ (DCIS)

• No nonepithelial breast malignancies such as sarcoma or lymphoma

• Previously treated with lumpectomy of a lesion no greater than 3 cm and axillary dissection of at least 6 lymph nodes or a sentinel node biopsy

• Six surgical clips in place delineating the margins of the tylectomy cavity

• Negative, inked histologic margins of lumpectomy (greater than 2 mm) OR re-excision specimen available for confirmation

• Negative mammography post-lumpectomy or post-excision if malignancy-associated microcalcifications were initially present

• No prior lumpectomy so extensive that the cosmetic result is low or poor prior to radiotherapy

• No more than 3 positive axillary nodes

• No proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless negative by biopsy

• No palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless nodes are histologically negative

• No extensive intraductal carcinoma, indicated by one of the following according to the Harvard definition:

• More than 25 % of invasive tumor is DCIS and DCIS is in adjacent breast tissue

• Intraductal carcinoma with microinvasion

• No previously treated contralateral breast cancer or synchronous ipsilateral breast cancer

• No evidence of suspicious microcalcifications

• No Paget's disease of the nipple

• No skin involvement by disease, regardless of tumor size

• No distant metastases

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Female

Menopausal status

• Not specified

Performance status

• Not specified

Life expectancy

• At least 2 years

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Technically suitable for breast radiotherapy

• No collagenous diseases (e.g., systemic lupus erythematosus, scleroderma, or dermatomyositis)

• No other medical condition that would limit life expectancy

• No psychiatric or addictive disorders that would preclude giving informed consent

• No other malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• At least 2 weeks since prior chemotherapy

• No concurrent chemotherapy during and for at least 2 weeks after completion of study therapy

Endocrine therapy

• Concurrent anastrozole or tamoxifen allowed

Radiotherapy

• No prior radiotherapy for the current malignancy

Surgery

• See Disease Characteristics

Other

• No prior nonhormonal therapy for the current malignancy

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin
United States	Foundation for Cancer Research and Education	Phoenix	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Radiation Therapy Oncology Group	National Cancer Institute (NCI), NRG Oncology

Country where clinical trial is conducted

United States, 

References & Publications (2)

Vicini F, Winter K, Straube W, Wong J, Pass H, Rabinovitch R, Chafe S, Arthur D, Petersen I, McCormick B. A phase I/II trial to evaluate three-dimensional conformal radiation therapy confined to the region of the lumpectomy cavity for Stage I/II breast ca — View Citation

Vicini F, Winter K, Wong J, Pass H, Rabinovitch R, Chafe S, Arthur D, Petersen I, White J, McCormick B. Initial efficacy results of RTOG 0319: three-dimensional conformal radiation therapy (3D-CRT) confined to the region of the lumpectomy cavity for stage — View Citation