CTRI/2024/10/074718尚未招募2 期
Acute skin toxicity comparison of adjuvant two-weekly accelerated hypofractionated versus three-weekly moderately hypofractionated radiotherapy in breast cancer- A Phase 2, open label, randomized control trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- JIPMER
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- 1.To compare the proportion of patients with cumulative more than or equal to grade 2 dermatitis according to RTOG Acute & CTCAE Version 5, anytime during or within 3 months post radiotherapy
研究概览
简要总结
Post operative breast cancer patients will be recruited into the study and randomized into two arms as control arm and intervention arm. Control arm patients will receive standard hypofractionation regimen with or with out nodal irradiation and intervention arm will receive 34Gy in 10 fractions in case of mastectomy and with tumor bed boost in case of breast conservative surgery. Patients will be reviewed 1 month, 3 months and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Female 2.more than or equal to 18 years of age 3.Invasive carcinoma of breast (cT1-3,N0-2a) 4.Post breast conserving surgery/mastectomy, with clear margin of more than or equal to 1mm, with or without axillary lymph node dissection for breast cancer(pT0-T3,N0-2a) 5.Written informed consent 6.Able to comply with follow-up up to 6 months.
排除标准
- •1.Advanced loco-regional disesase- cT4/ cN2b/cN3 tumors, known residual macroscopic local or nodal disease post-surgery, requirement for Internal mammary nodal RT (more than or equal to 4axillary nodal macrometastasis, radiologically positive IMN), Positive margin, 2.Metastatic disease 3.Breast reconstruction 4.Pregnancy 5.Prior radiotherapy in the thoracic and /or lower neck area 6.Past history of malignancy except (i) basal cell skin cancer, (ii) CIN cervix uteri or (iii) non-breast malignancy allowed if treated with curative intent and at least 5 years disease free 7.Contralateral and/or previous ipsilateral breast cancer, including DCIS, irrespective of date of diagnosis
- •Patients at low risk, eligible and willing for Accelerated partial breast irradiation (more than or equal to 50 years of age, tumor less than oe equal to 2 cm, ER-Positive, Her-2-neu -Negative, Grade 1-2, unicentric, unifocal, no EIC, LVSI, Node negative, clear surgical margin at least 2mm, no genetic mutation, no lobular pathology).
结局指标
主要结局
1.To compare the proportion of patients with cumulative more than or equal to grade 2 dermatitis according to RTOG Acute & CTCAE Version 5, anytime during or within 3 months post radiotherapy
时间窗: during radiotherapy or within 3 months post radiotherapy
次要结局
- To compare the time to first occurrence of more than or equal to grade 2 skin toxicities(first occurrence of more than or equal to grade 2 skin toxicities)
- To compare the change in EORTC Quality of life C30 score and EORTC BR 45 score from baseline prior to radiotherapy, to 6 months post radiotherapy(6 months post radiotherapy)
- To compare the proportion of patients with acute toxicities other than skin, according to RTOG Acute & CTCAE Version 5 Grades during and within 3 months post radiotherapy.(3 months post radiotherapy)
- To compare the proportion of dosimetric feasibility on treatment planning as per protocol, between two radiation dose prescriptions(start of radiotherapy)
- To compare the proportion of patients with ipsilateral local and or regional nodal relapse at 6 months post radiotherapy(6 months post radiotherapy)
- To compare the proportion of patients with late toxicities at 3-6 months according to RTOG Late & CTCAE Version 5 Grades post radiotherapy(6 months post radiotherapy)
研究者
研究点 (1)
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