Trial Title:
Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial)
NCT ID:
NCT05733689
Condition:
Gastroesophageal Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Paclitaxel
Docetaxel
Carboplatin
Pembrolizumab
Nivolumab
Irinotecan
Folfirinox
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
ctDNA Blood Test
Description:
Blood will be collected for ctDNA testing
Arm group label:
Neoadjuvant chemotherapy with ctDNA testing
Intervention type:
Combination Product
Intervention name:
FLOT
Description:
- 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
Arm group label:
Neoadjuvant chemotherapy with ctDNA testing
Intervention type:
Combination Product
Intervention name:
FOLFOX
Description:
- 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
Arm group label:
Neoadjuvant chemotherapy with ctDNA testing
Intervention type:
Combination Product
Intervention name:
FOLFIRI
Description:
- 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
Arm group label:
Neoadjuvant chemotherapy with ctDNA testing
Intervention type:
Combination Product
Intervention name:
FOLFIRINOX
Description:
- 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
Arm group label:
Neoadjuvant chemotherapy with ctDNA testing
Intervention type:
Combination Product
Intervention name:
PACLITAXEL with or without CARBOPLATIN
Description:
- 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
Arm group label:
Neoadjuvant chemotherapy with ctDNA testing
Intervention type:
Combination Product
Intervention name:
DOCETAXEL and IRINOTECAN (alone or combined)
Description:
- 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
Arm group label:
Neoadjuvant chemotherapy with ctDNA testing
Intervention type:
Drug
Intervention name:
NIVOLUMAB (alone or when added to a regimen above)
Description:
- 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
Arm group label:
Neoadjuvant chemotherapy with ctDNA testing
Intervention type:
Drug
Intervention name:
PEMBROLIZUMAB (alone or when added to a regimen above)
Description:
- 200 mg IV on Day 1 every 21 days, or
- 400 mg IV on Day 1 every 42 days
Arm group label:
Neoadjuvant chemotherapy with ctDNA testing
Summary:
This is a phase 1b prospective, single arm, open-label trial determining the efficacy and
feasibility of using a ctDNA assay (test) result to help guide neoadjuvant chemotherapy
in subjects with Stage IB, II or Stage III adenocarcinoma of the stomach or
gastroesophageal junction (GEA).
Criteria for eligibility:
Criteria:
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.
- Must have baseline ctDNA positive assay (tested by Signatera MRD assay) prior to
initiation of neoadjuvant chemotherapy. Patients who are otherwise eligible may
start per protocol treatment if ctDNA result is not available at the time of
initiation of systemic therapy. However, once the results is available, they can
only remain on study if the ctDNA is positive.
- 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. leukocytes ≥ 3,000/mcL
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 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chao Family Comprehensive Cancer Center, University
Address:
City:
Orange
Zip:
92868
Country:
United States
Contact:
Last name:
Farshid Dayyani, MD, PhD
Phone:
877-827-8839
Email:
ucstudy@uci.edu
Start date:
February 2025
Completion date:
February 2026
Lead sponsor:
Agency:
University of California, Irvine
Agency class:
Other
Collaborator:
Agency:
Natera, Inc.
Agency class:
Industry
Source:
University of California, Irvine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05733689
