Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: testing Oxaliplatin for Ampulla of Vater Carcinoma

This clinical trial is being done to learn whether using the proactive, graduated dose modification algorithm for leucovorin, 5-fluorouracil (5-FU), and oxaliplatin (FOLFOX) (PAGODA) algorithm to guide chemotherapy dosing for the FOLFOX regimen works to reduce unplanned treatment delays for patients with digestive system cancers compared to usual care. During standard of care treatment, chemotherapy dose changes or treatment delays are typically determined by the treating physician based on factors such as a patient's height, weight, and blood test results obtained before each treatment cycle.

Official registry: https://clinicaltrials.gov/study/NCT07283939 · Alliance for Clinical Trials in Oncology · enrollment listed as 420

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are PAGODA algorithm, Oxaliplatin, or Folinic Acid. The registry lists allocation as randomized. This clinical trial is being done to learn whether using the proactive, graduated dose modification algorithm for leucovorin, 5-fluorouracil (5-FU), and oxaliplatin (FOLFOX) (PAGODA) algorithm to guide chemotherapy dosing for the FOLFOX regimen works to reduce unplanned treatment delays for patients with digestive system cancers compared to usual care.

They plan to enroll about 420 people at 398 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: PAGODA algorithm, Oxaliplatin, Folinic Acid, Fluorouracil

Primary outcome (registry wording): Incidence of unplanned chemotherapy delays

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • \* 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

Public study contact (from the registry)

Lilli Johnson

(773) 702-9171

cancercontrolprotocols@allinancenctn.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

398 listed

+ 8 sites outside the US on the same record

FAQ about this NCT record

Is NCT07283939 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07283939?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07283939?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

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