RecruitingNot applicable

Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays

PAGODA: Randomized Trial of a Proactive Graduated Dose Modification Algorithm for FOLFOX Chemotherapy to Prevent Unplanned Delays

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether PAGODA, a set of rules for changing chemotherapy doses, can reduce unplanned treatment delays compared with usual care. It is for adults with cancer that starts, or likely starts, in the digestive system who are starting FOLFOX chemotherapy.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older, with cancer confirmed by a tissue test that starts, or likely starts, in the digestive system.
  • FOLFOX must be a standard treatment for your cancer. Plan to receive at least 4 cycles, each lasting 14 days.
  • Have completed the first day of FOLFOX 1 to 8 days before signing up. The first doses must meet the study’s requirements.
  • Be able to care for yourself and be out of bed or a chair for at least half of your waking hours.
  • Meet the study’s blood count, liver, and kidney test limits. If you could become pregnant, have a negative pregnancy test within 30 days before signing up.
  • If cancer has spread to the brain, scans after treatment must show it is not getting worse. If you have heart disease, it must cause no symptoms or only mild limits on activity.
  • If you have HIV or hepatitis B or C, virus tests must meet the study’s limits. HIV must be treated, and hepatitis C testing must be done at least 12 weeks after treatment ends.
  • Cancer doctors and advanced practice providers may also join if they manage chemotherapy orders for a patient in the PAGODA group, are at least 21, and know English well. They may join only once.

Who can't join

  • Past treatment with drugs that travel through the body to treat digestive system cancer, except the first FOLFOX cycle. Chemotherapy given to help radiation work is allowed.
  • Need medicine during the first FOLFOX cycle to prevent low white blood cells because of a high risk of fever with low infection-fighting blood cells.
  • A past allergic reaction to oxaliplatin or other platinum drugs, fluorouracil, leucovorin, or ingredients in these medicines.
  • Pregnant or breastfeeding.
  • Known inherited long QT syndrome, a condition that affects the heart’s rhythm.
  • Known DPD deficiency, a condition that makes it hard for the body to break down fluorouracil.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * \* 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

Study sites (360)

AK

AR

AZ

CA

CO

DE

FL

GA

IA

ID

IL

IN

KS

KY

LA

MD

ME

MI

MN

MO

MS

MT

NC

ND

NE

NM

NY

OH

OK

OR

PA

SC

SD

TN

VA

WA

WI

WY