Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial)
Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial) - a Phase Ib Feasibility Trial
University of California, Irvine
20 participants
Jun 27, 2025
INTERVENTIONAL
Conditions
Summary
This is a phase 1b prospective, single arm, open-label trial determining the efficacy and feasibility of using a response-guided approach to help guide neoadjuvant chemotherapy in subjects with Stage IB, II or Stage III adenocarcinoma of the stomach or gastroesophageal junction (GEA).
Eligibility
Inclusion Criteria17
- Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEA). Other GE histologies which are treated per NCCN guidelines for neoadjuvant treatment are eligible.
- Must have Stage IB, II or Stage III GEA eligible for (neo)adjuvant doublet or triplet chemotherapy for up to 6 months.
- Age ≥ 18 years Because the safety or efficacy of neoadjuvant chemotherapy for LGEA has not been tested or established for patients <18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable.
- Performance status: ECOG performance status ≤2
- Life expectancy of greater than 6 months
- Adequate organ and marrow function as defined below:
- hemoglobin ≥ 7g/dL
- absolute neutrophil count ≥ 1,500/mcL
- platelets ≥ 80,000/mcl
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SPGT) ≤ 5 X institutional upper limit of normal
- creatinine <2 X ULN
- Docetaxel can cause fetal harm and irinotecan is known to be teratogenic. Since these compounds are part of the treatment regimens, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- \. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Ability to understand and the willingness to sign a written informed consent. 1. Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, deaf, hard of hearing and illiterate individuals are eligible for this trial.
Exclusion Criteria8
- Patients may not be receiving any other investigational agents.
- Patients with known distant metastases from GEA.
- History of allergic reactions attributed to agents used in study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- History of another primary cancer which requires active treatment or is expected to require treatment within 12 months after enrollment.
- Inability to comply with study and follow-up procedures as judged by the Investigator.
- Patients who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
- Patients with prior organ/bone marrow/non-autologous stem cell transplants
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Interventions
* Oxaliplatin 85 mg/m2 IV on Day 1 * Docetaxel 50 mg/m2 IV on Day 1 * Leucovorin 200 mg/m2 IV on Day 1 * Fluorouracil 2600 mg/m2 continuous infusion over 24 hours daily on Day 1 Every 14 Days
* Oxaliplatin 85 mg/m2 IV on Day 1 * Leucovorin 400 mg/m2 IV on Day 1 * Fluorouracil 400 mg/m2 IV Push on Day 1 * Fluorouracil 1200 mg/m2 continuous infusion over 24 hours daily on Days 1 and 2 Every 14 Days
* Irinotecan 180 mg/m2 IV on Day 1 * Leucovorin 400 mg/m2 IV on Day 1 * Fluorouracil 400 mg/m2 IV Push on Day 1 * Fluorouracil 1200 mg/m2 continuous infusion over 24 hours daily on Days 1 and 2 Every 14 Days
* Oxaliplatin 85 mg/m2 IV on Day 1 * Irinotecan 150 mg/m2 IV on Day 1 * Leucovorin 200 mg/m2 IV on Day 1 * Fluorouracil 1200 mg/m2 continuous infusion over 24 hours daily on Days 1 and 2 Every 14 days
* Paclitaxel 200 mg/m2 IV on Day 1 * Carboplatin AUC 5 IV on day 1 Every 21 Days OR \- Paclitaxel 80mg/m2 IV on Days 1,8,15 Every 28 Days
* Docetaxel 35 mg/m2 IV on Days 1 and 8 * Irinotecan 50 mg/m2 IV on Days 1 and 8 Every 21 Days * Docetaxel 75 mg/m2 IV on Day 1 Every 21 Days * Docetaxel 150 mg/m2 IV on Day 1 Every 14 Days
* 240 mg IV on Day 1 every 14 days, or * 360 mg IV on Day 1 every 21 days, or * 480 mg IV on Day 1 every 28 days
* 200 mg IV on Day 1 every 21 days, or * 400 mg IV on Day 1 every 42 days
\- 1500 mg IV on Day 1 every 28 days
* 8 mg/kg on Day 1, then 6 mg/kg IV every 21 days, or * 6 mg/kg on Day 1, then 4 mg/kg IV every 14 days
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05733689