A Phase I Dose Escalation Trial: Concurrent Intensity-Modulated Radiotherapy (IMRT) and Chemotherapy With Molecular Image-Guided Adaptive Radiation Therapy (IGART) for Advanced Head and Neck Squamous Cell Carcinomas (HNSCC)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Feasibility of integrating molecular imaging (PET with FLT tracer) into current state-of-the-art image-guided adaptive radiation therapy (IGART) of head and neck cancer
研究概览
简要总结
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. CT and PET scans and treatment-planning systems may help in planning radiation therapy. 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. Giving radiation therapy together with cisplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of intensity-modulated image guided adaptive radiation therapy when given together with cisplatin in treating patients with locally advanced head and neck squamous cell cancer
详细描述
PRIMARY OBJECTIVES:
I. To determine the feasibility of integrating molecular imaging (PET with FLT tracer) into current state-of-the-art image-guided adaptive radiation therapy (IGART) of head and neck cancer.
II. To determine within a predefined range the maximum tolerated radiation dose for concurrent cisplatin and molecular and anatomic image-based IGART of head and neck cancer.
SECONDARY OBJECTIVES I. To compare gross tumor volumes defined by FDG-PET, FLT-PET, CBCT, and regular FBCT before, during, and following completion of chemo-radiation therapy.
II. To evaluate the impact of escalated doses to tumor sub-volumes with high FLT and FDG uptake prior to and during radiation therapy using post-treatment FDG images as an early surrogate for sub-volume-specific local control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic or cytologic confirmation of head and neck malignancy without clinical or radiographic evidence of metastatic disease
- •Locally advanced HN SCC, stages III, IV, and bulky (> 27 cm^3 volume) stage II, excluding larynx and nasopharynx, of no more than 150 cm^3 volume base on CT scan
- •All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines
- •Candidate for chemotherapy
- •Zubrod performance score of 0 or 1
- •Absolute granulocyte count (AGC) >= 2000 cells/mm^3
- •Platelet count >= 100,000 cells/mm^3
- •Hemoglobin > 8.0 g/dl based upon CBC/differential obtained within 2 weeks prior to registration on study
- •Serum creatinine =< 1.5 mg/dl or measured or calculated creatinine clearance >= 50 ml/min
- •Negative pregnancy test within 2 weeks prior to registration for women of childbearing potential
排除标准
- •Prior invasive malignancy except non-melanomatous skin cancers unless patient has been disease free for at least 3 years
- •Prior cancer treatment for this cancer, including gross total tumor excision
- •Prior radiation treatment to the HN region
- •Patients with known syndromes that alter radiosensitivity
- •Any medical contraindications for chemotherapy
- •Pregnant or lactating women
- •Women (of childbearing potential) and men who are sexually active and are not willing/able to use a medically acceptable form of contraception throughout the treatment and 60 days thereafter
研究组 & 干预措施
Arm I
Patients undergo intensity-modulated image-guided adaptive radiotherapy once daily 5 days a week for 6 weeks. Patients also receive cisplatin IV on days 1 and 22. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: 3'-deoxy-3'-[18F]fluorothymidine (Other)
Arm I
Patients undergo intensity-modulated image-guided adaptive radiotherapy once daily 5 days a week for 6 weeks. Patients also receive cisplatin IV on days 1 and 22. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: intensity-modulated radiation therapy (Radiation)
Arm I
Patients undergo intensity-modulated image-guided adaptive radiotherapy once daily 5 days a week for 6 weeks. Patients also receive cisplatin IV on days 1 and 22. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: cisplatin (Drug)
Arm I
Patients undergo intensity-modulated image-guided adaptive radiotherapy once daily 5 days a week for 6 weeks. Patients also receive cisplatin IV on days 1 and 22. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: image-guided adaptive radiation therapy (Radiation)
Arm I
Patients undergo intensity-modulated image-guided adaptive radiotherapy once daily 5 days a week for 6 weeks. Patients also receive cisplatin IV on days 1 and 22. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: positron emission tomography/computed tomography (Procedure)
Arm I
Patients undergo intensity-modulated image-guided adaptive radiotherapy once daily 5 days a week for 6 weeks. Patients also receive cisplatin IV on days 1 and 22. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: fludeoxyglucose F 18 (Radiation)
结局指标
主要结局
Feasibility of integrating molecular imaging (PET with FLT tracer) into current state-of-the-art image-guided adaptive radiation therapy (IGART) of head and neck cancer
时间窗: 6 weeks
次要结局
- Patient long-term toxicities and survival(At 2 and 4 weeks, 2, 3, 4, 5, 6, 9, and 12 months, every 6 months for 2 years, and then annually for 2 years)
- Impact of daily image-guided setup; off-line every other week adaptive re-planning; and molecular-image based targeting on sparing of tissues and organs responsible for late and early treatment sequelae(At 2 and 4 weeks, 2, 3, 4, 5, 6, 9, and 12 months, every 6 months for 2 years, and then annually for 2 years)
- Impact of escalated doses to tumor sub-volumes with high FLT and FDG uptake using post-treatment FDG images as an early surrogate for sub-volume-specific local control(Prior to and during radiation therapy)
- Comparison of gross tumor volumes defined by FDG-PET, FLT-PET, CBCT, and regular FBCT(Before, during, and following completion of chemoradiation therapy)
- Development of a database consisting of all molecular and anatomic images, including daily CBCT data sets, obtained during chemo-radiation therapy to support further research(Up to 5 years)