RecruitingAmpulla of Vater CarcinomaAppendix CarcinomaCarcinoma of Unknown Primary With Gastrointestinal Profile

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

Eligible age

18+ yrs

Accepts

All genders

Locations

34 states

Healthy volunteers

Yes

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About this study

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.

Sponsor: Alliance for Clinical Trials in Oncology

You may qualify if…

✓ \* 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