A Randomized Phase II/Phase III Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 252
- 试验地点
- 536
- 主要终点
- Progression-free survival (PFS), defined by the events of local-regional progression or recurrence, distant metastasis, or death from any cause, primarily at 2 years
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with chemotherapy or alone after surgery in treating salivary gland tumors.
PURPOSE: This randomized phase II/III trial is studying radiation therapy with or without chemotherapy to see how well it works in treating patients with high-risk malignant salivary gland tumors that have been removed by surgery.
详细描述
OBJECTIVES:
Primary
Phase II
- Determine the feasibility of conducting a cooperative group prospective clinical trial in patients with resected malignant salivary gland tumors.
- Acquire preliminary efficacy data comparing postoperative radiotherapy alone to concurrent chemotherapy and radiation using weekly cisplatin.
Phase III
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Pathologically proven diagnosis of a malignant major salivary gland tumor or malignant minor salivary gland tumor of the head and neck of the following histologic subtypes:
- •Intermediate-grade adenocarcinoma or intermediate-grade mucoepidermoid carcinoma
- •High-grade acinic cell carcinoma or high-grade (>30% solid component) adenoid cystic carcinoma
- •Surgical resection with curative intent within 8 weeks prior to registration
- •All patients must have a Medical Oncology evaluation within 4 weeks prior to registration
- •Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤ 1mm) or microscopically positive surgical margin; patients must be free of distant metastases based upon the following minimum diagnostic workup:
- •History/physical examination within 8 weeks prior to registration
- •Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to registration; at a minimum, contrast CT imaging of the chest is required (PET/CT is acceptable)
- •No patients with residual macroscopic disease after surgery
- •No prior systemic chemotherapy or radiation therapy for salivary gland malignancy
- •PATIENT CHARACTERISTICS:
- •Zubrod performance status 0-1
- •Absolute neutrophil count (ANC) ≥ 1,800 cells/mm^3
- •Platelets ≥ 100,000 cells/mm^3
- •Hemoglobin ≥ 8.0 g/dL (the use of transfusion or other intervention to achieve hemoglobin ≥ 8.0 g/dL is acceptable)
- •Serum creatinine < 2.0 mg/dL
- •Total bilirubin < 2 x the institutional upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x the institutional ULN
- •Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential
- •Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment
- •Not pregnant or nursing
- •Patients must be deemed able to comply with the treatment plan and follow-up schedule
- •Patients must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for central review
- •No prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
- •No severe, active co-morbidity, defined as follows:
- •Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- •Transmural myocardial infarction within the last 6 months
- •Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- •Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- •Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects (coagulation parameters are not required for entry into this protocol)
- •Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition (HIV testing is not required for entry into this protocol)
- •Protocol-specific requirements may also exclude immunocompromised patients
- •Pre-existing ≥ grade 2 neuropathy
- •No significant pre-existing hearing loss, as defined by the patient or treating physician
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior systemic chemotherapy or radiation therapy for salivary gland malignancy (prior chemotherapy for a different cancer is allowable)
- •No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- •No prior organ transplant
- •No concurrent hematopoietic growth factors (e.g., G-CSF or pegfilgrastim) during radiotherapy
- •No concurrent erythropoiesis-stimulating agents
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients undergo 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) 5 days a week for 6-6.5 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiotherapy.
干预措施: 3-dimensional conformal radiation therapy (Radiation)
Arm I
Patients undergo 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) 5 days a week for 6-6.5 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiotherapy.
干预措施: intensity-modulated radiation therapy (Radiation)
Arm II
Patients undergo 3D-CRT or IMRT as in arm I.
干预措施: 3-dimensional conformal radiation therapy (Radiation)
Arm II
Patients undergo 3D-CRT or IMRT as in arm I.
干预措施: intensity-modulated radiation therapy (Radiation)
Arm I
Patients undergo 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) 5 days a week for 6-6.5 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiotherapy.
干预措施: cisplatin (Drug)
结局指标
主要结局
Progression-free survival (PFS), defined by the events of local-regional progression or recurrence, distant metastasis, or death from any cause, primarily at 2 years
时间窗: From randomization to 2 years.
次要结局
- OS rate at 5 years(From randomization to 5 years.)
- Overall survival (OS) rate at 2 years(From randomization to 2 years.)
- Treatment-related toxicity, defined as any grade 3-4 adverse events (CTCAE v. 4) deemed to be definitely, probably, or possibly related to protocol treatment(From start of treatment to last follow-up.)
- Determine whether quality of life, fatigue and xerostomia differ as a function of treatment assignment at 3, 12, and 24 months after completing radiotherapy.(From randomization to 2 years.)
- Treatment-related mortality, defined as any death during or within 30 days of discontinuation of protocol treatment(From start of treatment to 30 days after the end of treatment.)
- Chemotherapy delivery as measured by percentage of protocol prescription given(From start of treatment to end of treatment.)
- Radiation delivery as measured by elapsed treatment days(From start of treatment to end of treatment.)
- PFS rate at 5 years(From randomization to 5 years.)