Phase II Study of Hypofractionated Radiation Therapy to Augment Immune Response in Patients With Metastatic GastroIntestinal Malignancies Progressing on Immune Therapy (ARM-GI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
This phase II trial studies how well radiation therapy works for the treatment of gastrointestinal cancer that are spreading to other places in the body (metastatic). Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. This trial is being done to determine if giving radiation therapy to patients who are being treated with immunotherapy and whose cancers are progressing (getting worse) can slow or stop the growth of their cancers. It may also help researchers determine if giving radiation therapy to one tumor can stimulate the immune system to attack other tumors in the body that are not targeted by the radiation therapy.
详细描述
PRIMARY OBJECTIVE:
I. To determine whether radiation therapy can convert overall response rates from progressive disease to stable or responsive disease as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version (v.) 1.1.
SECONDARY OBJECTIVES:
I. To define overall response rate by immune-Modified Response Evaluation Criteria in Solid Tumors (iRECIST) criteria.
II. To determine time to progression. III. To determine overall survival. IV. To determine local control in radiated lesion(s). V. To characterize the effect of distant radiation on unirradiated target lesions.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have a histologically, cytologically, or radiographically confirmed metastatic gastrointestinal (GI) malignancy (esophageal, gastroesophageal, gastric, small intestine, hepatocellular, pancreaticobiliary, colorectal, or anal cancer).
- •Patients must be receiving immunotherapy (checkpoint inhibitor or CTLA4 inhibitor) with overall response of progressive disease by RECIST criteria.
- •Patients must have at least one metastasis which is progressing as per RECIST criteria.
- •Patients must have 1-5 sites of disease meeting standard-of-care indications for palliative radiation therapy as adjudicated by the treating radiation oncologist. For example:
- •Symptomatic disease causing pain, bleeding, dyspnea, dysphagia, or nausea
- •At-risk for neurologic, respiratory, cardiovascular, gastrointestinal, musculoskeletal, or hepatobiliary compromise
- •Evaluation by a radiation oncologist within 28 days of study registration.
- •Must have adequate organ function to administer radiation therapy and immunotherapy as per standard of care.
- •Age >= 18 years.
- •Life expectancy exceeding 6 months.
- •Eastern Cooperative Oncology Group (ECOG) 0-2 or Karnofsky performance status >=
- •Radiation therapy is known to be teratogenic and therefore women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of radiation therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for 3 months after completion of radiation therapy. Contraception requirements during the follow-up period of 6 months will be according to standard of care for immunotherapy administration.
- •a. If a woman is of child-bearing potential, a negative pregnancy test within 28 days prior to study enrollment is required.
- •Ability to understand a written informed consent document, and the willingness to sign it.
排除标准
- •Enrollment on immunotherapy clinical trial for which radiation therapy is not permitted.
- •Administration of radiation therapy within 4 weeks prior to study enrollment.
- •Treatment with systemic corticosteroids or other immunosuppressive medications which would significantly diminish the effect of immunotherapy as judged by the treating physician.
- •Radiation therapy is contraindicated as adjudicated by the radiation oncologist.
研究组 & 干预措施
Radiation therapy (RT)
Patients undergo radiation therapy for a total of 5 treatments over 5-9 calendar days in the absence of disease progression or unacceptable toxicity. Target prescription dose will be 30 Gy in 5 fractions and each treatment site (up to 5) will undergo standard Department-approved treatment planning, quality-assurance, and delivery protocols
干预措施: Radiation Therapy (RT) (Radiation)
结局指标
主要结局
Overall response rate (ORR)
时间窗: Up to 8 weeks
Proportion of patients who achieve as their best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1 criteria: Stable disease (SD), partial response (PR), confirmed Complete Response (CR), or progressive disease (PD). Corresponding exact confidence intervals will be reported for the entire cohort and stratified by histologic subtype, programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) status, microsatellite instability (MSI), and organs treated if sample size allows. Patients with unevaluable or unknown response status will be considered nonresponders.
次要结局
- Frequency of grade 3 or higher adverse events(Up to 36 months)
- Progression free survival (PFS)(Up to 36 months)
- Overall survival (OS)(Up to 36 months)
- Determine local control in radiated lesion(s)(Up to 36 months)
- ORR by immune-Modified Response Evaluation Criteria in Solid Tumors (iRECIST)(Up to 8 weeks)
- Time to new systemic therapy(Up to 36 months)
- Tumor measurement change by RECIST or iRECIST(Up to 8 weeks)
- Incidence of New metastatic lesions(Up to 8 weeks)