A Randomized Phase II Trial Evaluating Toxicity and Efficacy Between Proton and Photon for Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related Xerostomia (≥Grade 2) as assessed by NCI CTCAE v4.03
研究概览
简要总结
The purpose of this study is to compare the toxicity and therapeutic efficacy of proton or photon combined with carbon ion radiotherapy for newly diagnosed nasopharyngeal carcinoma.Participants will be randomized to 2 arms. Arm 1, participants received photon combined with carbon ion radiotherapy group, Arm 2, participants received proton combined with carbon ion radiotherapy.
详细描述
The purpose of this study is to compare the toxicity and therapeutic efficacy of photon or proton combined with carbon ion radiotherapy for newly diagnosed nasopharyngeal carcinoma.Participants will be randomized to 2 arms. Arm 1 participants received photon combined with carbon ion radiotherapy (photon: 56 Gy/28 Fx, plus carbon: 15-17.5 gray equivalent [GyE]/5 Fx for boost). Arm 2, participants received proton combined with carbon ion radiotherapy (proton: 56 GyE/28 Fx, plus carbon: 15-17.5 GyE/5 Fx for boost). Adverse events will be documented according to CTCAE v4.03.The response of treatment will be evaluated according to RECIST criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed Nasopharyngeal carcinoma(WHO II/III type).
- •Age ≥ 18 and ≤ 70 years of age.
- •Eastern Cooperative Oncology Group score: 0-
- •Adequate laboratory values within 30 dyas of enrollment to study defined as follows: 1) neutrophil > 2000/mm^3; 2) platelet > 100,000/mm^3; 3) total bilirubin < 1.5mg/dl; 4) alanine aminotransferase/aspartate aminotransferase < 1.5 upper limit of normal; 5) SCr < 1.5mg/dl; creatinine clearance rate > 60ml/min.
- •Willing to accept adequate contraception for women with childbearing potential.
- •Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial.
排除标准
- •Presence of distant metastasis.
- •Received radiotherapy for head and neck before.
- •Received surgery(except for biopsy) for primary lesion or cervical lymph node.
- •Previous history of malignant tumor (within 5 years) or simultaneous existence of multiple primary tumors.
- •Presence of diseases (such as Sjögren syndrome) that may interfere evaluation of xerostomia.
- •Accompanied with severe major organ dysfunction.
- •Presence of mental disease that may influence the understanding of informed consent.
研究组 & 干预措施
Photon combined with Carbon ion
The participants received photon: 56 Gy/28 Fx for high-risk area(CTVhigh), 50.4 Gy/28 Fx for lower neck low-risk area(CTVlow), plus carbon ion: 15-17.5 GyE/5 Fx for boost for visible tumors.
干预措施: Carbon ion (Radiation)
Proton combined with Carbon ion
The participants received proton: 56 GyE/28 Fx for high-risk area(CTVhigh), 50.4 GyE/28 Fx for lower neck low-risk area(CTVlow), plus carbon ion: 15-17.5 GyE/5 Fx for boost for visible tumors.
干预措施: Proton (Radiation)
Proton combined with Carbon ion
The participants received proton: 56 GyE/28 Fx for high-risk area(CTVhigh), 50.4 GyE/28 Fx for lower neck low-risk area(CTVlow), plus carbon ion: 15-17.5 GyE/5 Fx for boost for visible tumors.
干预措施: Carbon ion (Radiation)
Photon combined with Carbon ion
The participants received photon: 56 Gy/28 Fx for high-risk area(CTVhigh), 50.4 Gy/28 Fx for lower neck low-risk area(CTVlow), plus carbon ion: 15-17.5 GyE/5 Fx for boost for visible tumors.
干预措施: Photon (Radiation)
结局指标
主要结局
Number of participants with treatment-related Xerostomia (≥Grade 2) as assessed by NCI CTCAE v4.03
时间窗: Xerostomia (≥Grade 2) occurred at 6 months after completion of radiotherapy
CTCAE refers to Common Terminology Criteria for Adverse Events, which is one of the most frequently used criteria for toxicity grading after anti-cancer treatment.
次要结局
- Local control(From randomization to local failure, a median of 3 years.)
- Overall survival of all patients(From randomization to death, a median of 3 years.)
- Progression-free survival of all patients(From randomization to death or disease progression, a median of 3 years.)
- Treatment-related adverse events as assessed by NCI CTCAE v4.03(Time interval from start to 3 months after completion of radiotherapy.)
- Distant control(From randomization to distant failure, a median of 3 year.)
- Regional control(From randomization to regional failure, a median of 3 years.)
研究者
Jiade J. Lu
Executive Vice-President
Shanghai Proton and Heavy Ion Center