- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Fase
- Fase 2
- Fase 1
Contatti e Sedi
Luoghi di studio
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Arizona
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Phoenix, Arizona, Stati Uniti, 85013
- Foundation for Cancer Research and Education
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Wisconsin
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Marshfield, Wisconsin, Stati Uniti, 54449
- CCOP - Marshfield Clinic Research Foundation
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Mascheramento: Nessuno (etichetta aperta)
Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Frank Vicini, MD, FACR, William Beaumont Hospital - Royal Oak Campus
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RTOG-0319
- CDR0000316246
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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