PAGODA: Randomized Trial of a Proactive Graduated Dose Modification Algorithm for FOLFOX Chemotherapy to Prevent Unplanned Delays
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 420
- 试验地点
- 370
- 主要终点
- Incidence of unplanned chemotherapy delays
研究概览
简要总结
This study seeks to learn whether using the PAGODA algorithm to guide chemotherapy dosing will lower the chance of unplanned delays during chemotherapy for cancer in the gastrointestinal system compared to usual care.
详细描述
The primary and secondary objectives of the study:
PRIMARY OBJECTIVE:
I. To compare the proportion of chemotherapy cycles with unplanned delays in patients receiving FOLFOX chemotherapy under standardized usual care (control) versus (vs) according to the PAGODA dose modification algorithm (intervention).
SECONDARY OBJECTIVES:
I. To compare the mean number of health care contact days (time toxicity) for patients receiving FOLFOX chemotherapy according to assignment to the control vs intervention arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- 是
入选标准
- •* REGISTRATION ELIGIBILITY CRITERIA (STEP 1)
- •Histologic confirmation of invasive cancer that is confirmed or suspected to arise from the gastrointestinal (GI) tract
- •Any stage for which FOLFOX-based chemotherapy is a clinically-indicated, standard-of-care treatment (adjuvant, neoadjuvant, or first-line chemotherapy)
- •Eligible primary tumor sites include the esophagus, gastroesophageal junction, stomach, small intestine, ampulla of Vater, appendix, colon, rectum, and cancers of unknown primary with suspected GI origin
- •Prior systemic therapy for GI cancer (other than cycle 1 of FOLFOX-based chemotherapy) is not allowed. Prior radiation-sensitizing chemotherapy is permitted
- •The planned duration of FOLFOX-based chemotherapy must be at least four cycles (1 cycle = 14 days)
- •Cycle 1, day 1 of FOLFOX-based chemotherapy must be completed 1 to 8 days prior to registration
- •Cycle 1, day 1 of FOLFOX-based chemotherapy must include minimum ordered doses of oxaliplatin (≥ 65 mg/m^2) and infusional 5-FU (2400 mg/m^2/46 hours). Use of the 5-FU bolus is at the discretion of the treating physician
- •Patients who require primary prophylactic white blood cell growth factor with cycle 1 of FOLFOX chemotherapy due to high risk for fever and neutropenia are not eligible
- •History of hypersensitivity reaction to oxaliplatin or other platinum-based drugs, to fluorouracil, or to leucovorin, and the excipients in their formulations are not eligible
- •Age ≥ 18 years
- •ECOG performance status ≤ 2
- •Absolute neutrophil count (ANC) ≥ 1,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Total bilirubin ≤ 3 x upper limit of normal (ULN)
- •AST (SGOT)/ALT (SGPT) ≤ 5 x upper limit of normal (ULN)
- •Calc. creatinine clearance ≥ 30 mL/min
- •Not pregnant and not nursing, because this study involves agents that have known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 30 days prior to registration is required
- •Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression
- •Patients with known HIV infection are eligible if receiving effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration
- •Patients with known chronic hepatitis B virus (HBV) infection are eligible if HBV DNA is undetectable when measured within 6 months prior to registration
- •Patients with a known history of hepatitis C virus (HCV) infection are eligible if HCV RNA is undetectable when measured at least 12 weeks after completion of antiviral therapy
- •Patients with known history or current symptoms of cardiac disease are eligible if the New York Heart Association Functional Classification is class I or II
- •Patients with a known history of congenital long QT syndrome are ineligible
- •Patients with known DPD deficiency are ineligible
- •* NON-PATIENT (ONCOLOGY PHYSICIAN OR ONCOLOGY ADVANCED PRACTICE PROVIDER ELIGIBILITY:
- •The non-patient provider participant is a medical oncologist or oncology advanced practice provider with responsibility for signing and making necessary modifications to chemotherapy orders for a subject assigned to the intervention arm (Arm B). Non-patient participants may not be enrolled more than once over the course of the study
- •The non-patient participant must be proficient in the English language
- •The non-patient participant must be age 21 years or older
排除标准
- 未提供
研究组 & 干预措施
Arm B- PAGODA Algorithm
Patients receive chemotherapy delays and dose modifications based on PAGODA algorithm followed by treating clinician decision during cycles 2-7 of SOC FOLFOX chemotherapy on study.
干预措施: PAGODA algorithm (Other)
Arm A- Physician Discretion
Patients receive chemotherapy delays and dose modifications at the discretion of the treating clinician during cycles 2-7 of SOC FOLFOX chemotherapy on study.
干预措施: Folinic Acid (Drug)
Arm A- Physician Discretion
Patients receive chemotherapy delays and dose modifications at the discretion of the treating clinician during cycles 2-7 of SOC FOLFOX chemotherapy on study.
干预措施: Oxaliplatin (Drug)
Arm B- PAGODA Algorithm
Patients receive chemotherapy delays and dose modifications based on PAGODA algorithm followed by treating clinician decision during cycles 2-7 of SOC FOLFOX chemotherapy on study.
干预措施: Fluorouracil (Drug)
Arm B- PAGODA Algorithm
Patients receive chemotherapy delays and dose modifications based on PAGODA algorithm followed by treating clinician decision during cycles 2-7 of SOC FOLFOX chemotherapy on study.
干预措施: Oxaliplatin (Drug)
Arm B- PAGODA Algorithm
Patients receive chemotherapy delays and dose modifications based on PAGODA algorithm followed by treating clinician decision during cycles 2-7 of SOC FOLFOX chemotherapy on study.
干预措施: Folinic Acid (Drug)
Arm A- Physician Discretion
Patients receive chemotherapy delays and dose modifications at the discretion of the treating clinician during cycles 2-7 of SOC FOLFOX chemotherapy on study.
干预措施: Fluorouracil (Drug)
结局指标
主要结局
Incidence of unplanned chemotherapy delays
时间窗: From cycle 2 to 7 (Undelayed cycle length= 14 days)
Will employ a generalized linear mixed effects model with logit link function, with a random patient effect to account for clustering of cycles within patients. Will test if additional random effects are needed (e.g., provider or clinic level). Statistical significance will be assessed at the 5% level. Delays will be assessed over cycles 2 through 7, and a delay will be defined as an interval of \> 18 days since day 1 of the previous cycle. An unplanned delay will be defined as any delay that was not prospectively planned by day 3 of the previous cycle.
次要结局
- Time toxicity(From registration to 120 days after registration.)
- Moderate-to-severe neutropenia(From the start of cycle 2 to 30 days after start of cycle 7 (undelayed cycle length= 14 days))
- Chemotherapy relative dose intensity(Time Frame: From the start of cycle 1 to day 14 of cycle 6 (undelayed cycle length= 14 days).)