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

Inclusion Criteria:

• Patients must have histologically or cytologically confirmed adenocarcinoma of thestomach or gastroesophageal junction (GEA). Other GE histologies which are treatedper NCCN guidelines for neoadjuvant treatment are eligible.

• Must have Stage IB, II or Stage III GEA eligible for (neo)adjuvant doublet ortriplet chemotherapy for up to 6 months.

• Age ≥ 18 years Because the safety or efficacy of neoadjuvant chemotherapy for LGEAhas not been tested or established for patients <18 years of age, children areexcluded from this study but will be eligible for future pediatric trials, ifapplicable.

• 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. Sincethese compounds are part of the treatment regimens, women of child-bearing potentialand men must agree to use adequate contraception (hormonal or barrier method ofbirth control; abstinence) prior to study entry, for the duration of studyparticipation, and for 90 days following completion of therapy. Should a womanbecome pregnant or suspect she is pregnant while participating in this study, sheshould inform her treating physician immediately.

1. A female of child-bearing potential is any woman (regardless of sexualorientation, having undergone a tubal ligation, or remaining celibate by choice) whomeets the following criteria:

2. Has not undergone a hysterectomy or bilateral oophorectomy; or

3. 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 thistrial. Non-English speaking, deaf, hard of hearing and illiterate individuals areeligible 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 activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliancewith study requirements.

• History of another primary cancer which requires active treatment or is expected torequire treatment within 12 months after enrollment.

• Inability to comply with study and follow-up procedures as judged by theInvestigator.

• Patients who are pregnant or nursing due to the potential for congenitalabnormalities and the potential of this regimen to harm nursing infants.

• Patients with prior organ/bone marrow/non-autologous stem cell transplants