- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00068263
3-Dimensional Conformal Radiation Therapy In Treating Women With Stage I or Stage II Breast Cancer Previously Treated With Lumpectomy and Axillary Node Dissection
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
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.
Studienübersicht
Detaillierte Beschreibung
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.
Studientyp
Phase
- Phase 2
- Phase 1
Kontakte und Standorte
Studienorte
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-
Arizona
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Phoenix, Arizona, Vereinigte Staaten, 85013
- Foundation for Cancer Research and Education
-
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Wisconsin
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Marshfield, Wisconsin, Vereinigte Staaten, 54449
- CCOP - Marshfield Clinic Research Foundation
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Maskierung: Keine (Offenes Etikett)
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Frank Vicini, MD, FACR, William Beaumont Hospital - Royal Oak Campus
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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 I/ II breast carcinoma. Int J Radiat Oncol Biol Phys. 2010 Jul 15;77(4):1120-7. doi: 10.1016/j.ijrobp.2009.06.067. Epub 2009 Nov 10.
- 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 carcinoma: initial report of feasibility and reproducibility of Radiation Therapy Oncology Group (RTOG) Study 0319. Int J Radiat Oncol Biol Phys. 2005 Dec 1;63(5):1531-7. doi: 10.1016/j.ijrobp.2005.06.024. Epub 2005 Sep 29.
- Chafe S, Moughan J, McCormick B, Wong J, Pass H, Rabinovitch R, Arthur DW, Petersen I, White J, Vicini FA. Late toxicity and patient self-assessment of breast appearance/satisfaction on RTOG 0319: a phase 2 trial of 3-dimensional conformal radiation therapy-accelerated partial breast irradiation following lumpectomy for stages I and II breast cancer. Int J Radiat Oncol Biol Phys. 2013 Aug 1;86(5):854-9. doi: 10.1016/j.ijrobp.2013.04.005. Epub 2013 May 29.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- RTOG-0319
- CDR0000316246
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