Response-adapted neoadjuvant therapy for gastroesophageal adenocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1b, prospective, single-arm, open-label trial that uses early treatment response to guide neoadjuvant chemotherapy decisions for adults with stage IB–III gastroesophageal adenocarcinoma. Participants receive standard neoadjuvant regimens (including FLOT, FOLFOX, FOLFIRI, FOLFIRINOX, or paclitaxel with or without carboplatin) and treatment is adapted based on predefined response criteria during the neoadjuvant period. The primary focus is feasibility and early signals of efficacy from a response-guided approach before surgery, with clinical, radiographic, and laboratory monitoring to determine treatment changes. All subjects are treated at the University of California, Irvine Chao Family Comprehensive Cancer Center and followed through their perioperative period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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:

  1. hemoglobin ≥ 7g/dL
  2. absolute neutrophil count ≥ 1,500/mcL
  3. platelets ≥ 80,000/mcl
  4. total bilirubin within normal institutional limits
  5. AST(SGOT)/ALT(SPGT) ≤ 5 X institutional upper limit of normal
  6. 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.

  1\. 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:
  1. Has not undergone a hysterectomy or bilateral oophorectomy; or
  2. 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 Criteria:

* 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

Where it's running

• Chao Family Comprehensive Cancer Center, University
  Orange, California, United States Recruiting

Study contacts

• Principal investigator: Farshid Dayyani, MD,PhD — Chao Family Comprehensive Cancer Center
• Study coordinator: Chao Family Comprehensive Cancer Center University of California, Irvine
• Email: ucstudy@uci.edu
• Phone: 1-877-827-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.