Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Endometrial Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- The study will evaluate the feasibility of using helical tomotherapy to deliver IMRT in post-hysterectomy endometrial cancer patients receiving adjuvant radiotherapy.
研究概览
简要总结
This study is evaluating the feasibility of using helical tomotherapy to deliver IMRT in post-hysterectomy endometrial cancer patients receiving adjuvant radiotherapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 years of age
- •Karnofsky Performance Status of greater than or equal to 60
- •FIGO Surgical Stage I, II, and III
- •Pathologic confirmation of endometrial cancer
- •Patient status post hysterectomy
- •Patients with local or regional metastases are eligible for this protocol, but not those with distant metastases
- •Patients must have adequate:
- •Bone Marrow Function:
- •ANC ≥ 1,500/mcl (< CTCAE v 3.0 Grade 1).
- •Platelets ≥ 100,000/mcl (< CTCAE v3.0 Grade 1).
- •Renal Function:
- •Serum creatinine ≤ institutional upper limit normal (ULN) (CTCAE v 3.0 Grade 0). Note: if serum creatinine > ULN, a 24-hour creatinine clearance must be collected and must be > 50 mL/min.
- •Hepatic Function:
- •Bilirubin ≤ 1.5 x ULN (< CTCAE v 3.0 Grade 1).
- •SGOT≤ 2.5 x ULN (< CTCAE v 3.0 Grade 1).
- •Alkaline phosphatase ≤ 2.5 x ULN (< CTCAE v 3.0 Grade 1).
- •Neurologic Function:
- •Neuropathy (sensory and motor) < CTCAE v 3.0 Grade 1.
排除标准
- •Age less than 18 years of age
- •Karnofsky Performance Status less than 60
- •Radiographic or pathologic evidence of metastatic disease (other than pelvic or para-aortic lymph nodes)
- •Prior pelvic radiation therapy
研究组 & 干预措施
IMRT with chemotherapy
IMRT (upper third of vagina & para-vaginal tissue and the common, external and internal iliac nodal regions) 160-180 cGy daily fractions for a total dose of 4500-5120 cGy. Once a day treatment four to five days a week for approximately 6 weeks.
Intracavitary vaginal brachytherapy - some patients will be given this and it will be decided by the treating physician.
Carboplatin - AUC 6, IV over 30-60 minutes following completion of paclitaxel, given once every 3 weeks (3 weeks=1 cycles) for a total of 6 cycles
Paclitaxel - 175 mg/m2, 3 hour continuous IV infusion, administered prior to carboplatin, given once every 3 weeks (3 weeks=1 cycles) for a total of 6 cycles
干预措施: IMRT (Radiation)
IMRT with chemotherapy
IMRT (upper third of vagina & para-vaginal tissue and the common, external and internal iliac nodal regions) 160-180 cGy daily fractions for a total dose of 4500-5120 cGy. Once a day treatment four to five days a week for approximately 6 weeks.
Intracavitary vaginal brachytherapy - some patients will be given this and it will be decided by the treating physician.
Carboplatin - AUC 6, IV over 30-60 minutes following completion of paclitaxel, given once every 3 weeks (3 weeks=1 cycles) for a total of 6 cycles
Paclitaxel - 175 mg/m2, 3 hour continuous IV infusion, administered prior to carboplatin, given once every 3 weeks (3 weeks=1 cycles) for a total of 6 cycles
干预措施: Intracavitary vaginal brachytherapy (Radiation)
IMRT with chemotherapy
IMRT (upper third of vagina & para-vaginal tissue and the common, external and internal iliac nodal regions) 160-180 cGy daily fractions for a total dose of 4500-5120 cGy. Once a day treatment four to five days a week for approximately 6 weeks.
Intracavitary vaginal brachytherapy - some patients will be given this and it will be decided by the treating physician.
Carboplatin - AUC 6, IV over 30-60 minutes following completion of paclitaxel, given once every 3 weeks (3 weeks=1 cycles) for a total of 6 cycles
Paclitaxel - 175 mg/m2, 3 hour continuous IV infusion, administered prior to carboplatin, given once every 3 weeks (3 weeks=1 cycles) for a total of 6 cycles
干预措施: Paclitaxel (Drug)
IMRT with chemotherapy
IMRT (upper third of vagina & para-vaginal tissue and the common, external and internal iliac nodal regions) 160-180 cGy daily fractions for a total dose of 4500-5120 cGy. Once a day treatment four to five days a week for approximately 6 weeks.
Intracavitary vaginal brachytherapy - some patients will be given this and it will be decided by the treating physician.
Carboplatin - AUC 6, IV over 30-60 minutes following completion of paclitaxel, given once every 3 weeks (3 weeks=1 cycles) for a total of 6 cycles
Paclitaxel - 175 mg/m2, 3 hour continuous IV infusion, administered prior to carboplatin, given once every 3 weeks (3 weeks=1 cycles) for a total of 6 cycles
干预措施: Carboplatin (Drug)
结局指标
主要结局
The study will evaluate the feasibility of using helical tomotherapy to deliver IMRT in post-hysterectomy endometrial cancer patients receiving adjuvant radiotherapy.
时间窗: 1 year from the start of radiation therapy.
The study will be deemed infeasible if greater than 10% of patients experience one of the following: * Patient cannot be given the treatment because her anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised for her. * The patient experiences any grade 4 acute toxicity judged to be related to her external radiation treatment. * Within 1 year of the start of radiation therapy, the patient develops any grade 4 late toxicity judged to be related to her external radiation treatment. * Within 1 year of the start of radiation therapy, the patient develops any in-field pelvic recurrence. * Within 1 year of the start of radiation therapy, the patient dies from causes judged to be related to her treatment.
次要结局
- Evaluate local, regional, and distant recurrence rates(5 years from start of radiation therapy)
- Evaluate incidence of early toxicities(30 days after last day of radiation therapy)
- Evaluate incidence of late toxicities(1 year from the start of radiation therapy)
- Evaluate 5-year disease-free and 5-year overall survival rates(5 years from start of radiation therapy)