Clinical trial · Interventional
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
NCT00068263CI-TRIAL-00025338completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 malignancyReferences
Publications (4)
- RESULTVicini 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. PMID 19910132
- RESULTVicini 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. PMID 16198508
- RESULTVicini F, Winter K, Straube W, et al.: 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/ II breast carcinoma: initial report of feasibility and reproducibility of Radiation Therapy Oncology Group (RTOG) study 0319. [Abstract] Breast Cancer Res Treat 88 (Suppl 1): A-4067, 2004.
- DERIVEDChafe 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. PMID 23726000