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| ID | Type | Description | Link |
|---|---|---|---|
| UCI 21-191 | Other Identifier | CFCCC |
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| Name | Class |
|---|---|
| BillionToOne Inc. | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant chemotherapy with ctDNA testing | Experimental | The patients will be treated with one of the standard neoadjuvant protocols (FLOT or FOLFOX.) If patient response to their treatment, as measured by CT Scans or MRI results or blood tests done to look tumor markers such as carcinoembryonic antigen (CEA) and Carbohydrate antigen 19-9 (CA19-9) a change in adjuvant treatment will be made. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLOT | Combination Product |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of completing per protocol treatment. | Percent of patients who will undergo attempt at curative intent resection. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients completing gastrectomy. | Percent of patients completing gastrectomy | Up to 3 years |
| Rate of negative ctDNA after completion of neoadjuvant treatment and within 8 weeks after surgery |
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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:
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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chao Family Comprehensive Cancer Center University of California, Irvine | Contact | 1-877-827-8839 | ucstudy@uci.edu | |
| University of California Irvine Medical | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Farshid Dayyani, MD,PhD | Chao Family Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chao Family Comprehensive Cancer Center, University | Recruiting | Orange | California | 92868 | United States |
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| FOLFOX | Combination Product |
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| FOLFIRI | Combination Product |
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| FOLFIRINOX | Combination Product |
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| PACLITAXEL with or without CARBOPLATIN | Combination Product |
OR - Paclitaxel 80mg/m2 IV on Days 1,8,15 Every 28 Days |
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| DOCETAXEL and IRINOTECAN (alone or combined) | Combination Product |
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| NIVOLUMAB (alone or when added to a regimen above) | Drug |
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| PEMBROLIZUMAB (alone or when added to a regimen above) | Drug |
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| Durvalumab | Drug | - 1500 mg IV on Day 1 every 28 days |
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| Trastuzumab | Drug |
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Percent of patients with ctDNA clearance after neoadjuvant chemotherapy and after surgery (within 6-8 weeks)
| 8 weeks |
| Rate of R0 resection | R0 resection is defined as complete tumor removal with negative surgical margins. | Up to 3 years |
| Percentage of Grade 3-5 Adverse Events | Toxicity and adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0. | Up to 3 years |
| Relapse-free survival time | The lead time in ctDNA detection before clinical recurrence | Up to 3 years |
| ID | Term |
|---|---|
| C410216 | Folfox protocol |
| C480833 | IFL protocol |
| C000627770 | folfirinox |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| D000077143 | Docetaxel |
| D000077146 | Irinotecan |
| D012847 | Single Person |
| D000077594 | Nivolumab |
| C582435 | pembrolizumab |
| C000613593 | durvalumab |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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