EUCTR2005-001484-64-BE进行中（未招募）不适用
Chemotherapy for Radically Resected Loco-regional RelapseA randomized clinical trial of adjuvant chemotherapy for radically resectedloco-regional relapse of breast cancerChemotherapy vs. Observation - Chemotherapy for Radically Resected Loco-regional Relapse
International Breast Cancer Study Group (IBCSG)0 个研究点目标入组 265 人开始时间: 2006年3月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 265
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Histologically verified first local and/or regional (ipsilateral axillary or internal mammary lymph node) recurrence of invasive breast cancer following primary treatment with mastectomy or lumpectomy/quadrantectomy with clear surgical margins. Regional lymph node staging and radiation therapy at primary treatment are not eligibility criteria.
- •Local failure is defined as tumor recurrence in any soft tissue of the ipslateral conserved breast or the chest wall, mastectomy scar, and/or skin.
- •Regional failure is defined as a tumor recurrence in the ipsilateral axillary lymph nodes, extranodal soft tissue of the ipsilateral axilla, and/or ipsilateral internal mammography. Regional failure does not include supraclavicular lymph nodes or tumor in the opposite breast.
- •Surgical resection of the recurrence with uninvolved (clear”) margins (R0). Planned radiotherapy with =40 Gy for patients who had no adjuvant radiation treatment OR
- •Mastectomy of the recurrence with uninvolved ('clear') margins (R0) after lumpectomy/quadrantectomy alone for the primary. Radiotherapy is recommended but NOT mandatory OR
- •Surgical resection with microscopically involved margins (R1): Patients are eligible only if radiation treatment with =40 Gy is planned. The radiation therapy must at least involve the positive resection margin and a safety margin. Localized fields with techniques using an adequate radiation dose ( such as electron beam therapy or brachytherapy) are permitted.
- •No evidence of distant metastasis on standard staging examinations (x-ray or CT scan of the chest, ultrasound or CT scan of the abdomen and pelvis, bone scintigraphy) only if alkaline phosphatase is > 2x normal or if medically indicated (e.g. bone pain).
- •Measurement of hormone receptors in the recurrent tumor by the locally preferred method (immunohistochemistry and/or ligand binding assay). Each institution should use its own standard for defining endocrine-responsive disease (ER+ and/or PgR+). These standards should be defined prospectively.
- •Medically suitable for chemotherapy of 3 to 6 months duration.
- •Written informed consent.
- •Patients must be informed of, and agree to, data and material transfer and handling, in accordance with national data protection guidelines.
- •Patients must be geographically accessible for follow-up.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with macroscopically incomplete surgery.
- •Patients with microscopically involved margins of resection and impossibility (because of prior radiotherapy) to apply =40 Gy of local radiation therapy.
- •Patients with bilateral malignancy (except in situ carcinoma), or with a suspicious mass in the opposite breast, unless that mass has been proven by biopsy to be benign.
- •Evidence of distant metastasis (including ipsilateral supraclavicular lymph nodes).
- •Patients who have had a prior recurrence in any site, including local (except the first loco-regional recurrence described under inclusion criteria).
- •Patients, who, before randomization, have skeletal pain of unknown cause, elevated alkaline phosphatase, or a bone scan showing hot spots for which metastases cannot be ruled out by X-ray, MRI and/or CT.
- •Patients with other primary malignant tumors except adequately treated carcinoma in situ of the uterine cervix and non-melanoma skin cancer.
- •Patients with non-malignant systemic diseases that would prevent them from undergoing any of the treatment options, or would prevent prolonged follow-up.
- •Patients with psychiatric or addictive disorders that would prevent them from giving informed consent to randomization and therapy.
- •Patients with a history of noncompliance to medical regimens and patients who are considered potentially unreliable.
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