RECRUITING

Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial)

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Conditions

Gastroesophageal Adenocarcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial) - a Phase Ib Feasibility Trial

Quick Facts

Study Start:2025-06-27
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05733689

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Must have Stage IB, II or Stage III GEA eligible for (neo)adjuvant doublet or triplet chemotherapy for up to 6 months.
  3. * 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.
  4. * Performance status: ECOG performance status ≤2
  5. * Life expectancy of greater than 6 months
  6. * Adequate organ and marrow function as defined below:
  7. 1. hemoglobin ≥ 7g/dL
  8. 2. absolute neutrophil count ≥ 1,500/mcL
  9. 3. platelets ≥ 80,000/mcl
  10. 4. total bilirubin within normal institutional limits
  11. 5. AST(SGOT)/ALT(SPGT) ≤ 5 X institutional upper limit of normal
  12. 6. creatinine \<2 X ULN
  13. * 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.
  14. 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:
  15. 1. Has not undergone a hysterectomy or bilateral oophorectomy; or
  16. 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).
  17. * 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.
  1. * Patients may not be receiving any other investigational agents.
  2. * Patients with known distant metastases from GEA.
  3. * History of allergic reactions attributed to agents used in study.
  4. * 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.
  5. * History of another primary cancer which requires active treatment or is expected to require treatment within 12 months after enrollment.
  6. * Inability to comply with study and follow-up procedures as judged by the Investigator.
  7. * Patients who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
  8. * Patients with prior organ/bone marrow/non-autologous stem cell transplants

Contacts and Locations

Study Contact

Chao Family Comprehensive Cancer Center University of California, Irvine
CONTACT
1-877-827-8839
ucstudy@uci.edu
University of California Irvine Medical
CONTACT

Principal Investigator

Farshid Dayyani, MD,PhD
PRINCIPAL_INVESTIGATOR
Chao Family Comprehensive Cancer Center

Study Locations (Sites)

Chao Family Comprehensive Cancer Center, University
Orange, California, 92868
United States

Collaborators and Investigators

Sponsor: University of California, Irvine

  • Farshid Dayyani, MD,PhD, PRINCIPAL_INVESTIGATOR, Chao Family Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-27
Study Completion Date2026-02

Study Record Updates

Study Start Date2025-06-27
Study Completion Date2026-02

Terms related to this study

Additional Relevant MeSH Terms

  • Gastroesophageal Adenocarcinoma