Please select the eligibility criteria that correspond to the clinical trial below.
Title: Multicenter Randomized Controlled Trial of Combination Antiemetic Therapy With Aprepitant / Fosaprepitant in Patients With Colorectal Cancer Receiving Oxaliplatin-based Chemotherapy
Brief Summary: The object of this study is to evaluate the superiority of aprepitant therapy with a 5HT3-receptor antagonist, dexamethasone and aprepitant compared to standard therapy with a 5HT3-receptor antagonist and dexamethasone for prevention of nausea and vomiting in first course chemotherapy.


Options:
A: Inclusion Criteria:

* Patients aged 20 or more at the time when they give consent.
* Diagnosed as malignant disease.
* Be naive to chemotherapy or have been treated with single administration of anti-tumor drugs which are classified as low emetogenicity in the first edition of the 2006 NCCN Clinical Practice Guidelines.
* Cisplatin ≥50 mg/m2 Doxorubicin + cyclophosphamide: AC Epirubicin + cyclophosphamide: EC
* WBC ≥ 3000 /mm3 AST \< 100 IU/L ALT \< 100 IU/L Creatinine clearance ≥ 60 mL/min
* Performance Status : 0 - 2

Exclusion Criteria:

* Severe (requiring hospitalization) and uncontrollable complications.
* Metastases to the brain which are symptomatic.
* Seizure disorder requiring anticonvulsant medication unless clinically stable and free of seizure activity.
* Symptomatic and invasive procedure indicated ascites or pleural effusion.
* Have either gastric outlet stenosis or intestinal obstruction.
* Have ongoing emesis or CTCAE grade 2 or greater nausea.
* QTc \> 470 msec in the 12-lead ECG within eight days before registration.
* Known anaphylactic to ingredients of the study drug, namely palonosetron or granisetron hydrochloride injection, or other 5-HT3 receptor antagonists.
* Known anaphylactic to ingredients of dexamethasone.
* Pregnant women, breast-feeding women, or any male or female who are not willing to practice adequate contraception during the study period.
B: Inclusion Criteria:

* 18 years of age or older, of either gender, and of any race
* Naïve to moderately or highly emetogenic chemotherapy, and is to receive a first course of MEC including one or more of the following agents: cyclophosphamide IV (\<1500 mg/m2), doxorubicin, epirubicin, carboplatin, idarubicin, ifosfamide, irinotecan, daunorubicin, cytarabine IV (\>1 g/m2).
* Karnofsky performance score of ≥60
* Predicted life expectancy of ≥4 months
* Adequate bone marrow, kidney, and liver function

Exclusion Criteria:

* Contraindication to the administration of prescribed MEC agent,granisetron, or dexamethasone
* Is pregnant or breast feeding
* Has taken the following agents within the last 48 hours 5-HT3 antagonists,Phenothiazines,Benzamides,Domperidone,Cannabinoids,NK1 antagonist, Benzodiazepines
* Scheduled to receive any other chemotherapeutic agent with an emetogenicity level of 3 or above (Hesketh Scale) from Day -2 through Day 6, except on Day 1
* Scheduled to receive any radiation therapy to the abdomen or pelvis from Day -5 through Day 6
* Has received systemic corticosteroids or sedative antihistamines within 72 hours of Day 1 of the study except as premedication for chemotherapy (e.g., taxanes)
* Symptomatic primary or metastatic CNS disease.
* Has ongoing vomiting, retching, clinically significant nausea caused by any etiology, or has a history of anticipatory nausea and vomiting.
* Has vomited and/or has had dry heaves/retching within 24 hours prior to the start of MECon Day 1 in Cycle 1.
C: Inclusion Criteria:

* Age: ≥20 years old
* Sex: Not specified
* Patients with colon/rectal cancer who first underwent FOLFOX, XELOX or SOX regimen including oxaliplatin at ≥85 mg/m2 (naive patient), or those who had already started chemotherapy and had nausea of Grade 2 or higher in the last course or an earlier course (non-naive patient).
* Stage: not specified (neoadjuvant/adjuvant chemotherapy, advanced or recurrent type are allowed)
* Combination of molecular targeted therapy: allowable
* Written informed consent for participation in the study.

Exclusion Criteria:

* Severe liver or kidney disease
* Nausea/vomiting within 24 hr prior to chemotherapy.
* Treatment with antiemetics within 24 hr prior to chemotherapy.
* Presence of factors causing nausea/vomiting other than chemotherapy (e.g. brain tumor, gastrointestinal obstruction, active peptic ulcer disease, brain metastasis)
* Presence of a disease precluding 3-day administration of dexamethasone (e.g. uncontrollable diabetes)
* Pregnant or lactating women, women who plan to become pregnant.
* Current treatment with pimozide.
* Any patient judged to be inappropriate for the study by the investigator.
D: Inclusion Criteria:

* Has a histologically or cytologically confirmed malignant disease
* Is naive to moderately and highly emetogenic chemotherapy
* Is scheduled to receive a single IV dose of one or more MEC agents on Day 1, except for the combination of anthracycline and cyclophosphamide
* Has a predicted life expectancy of at least 4 months, and a Karnofsky score of at least 60 indicating that the participant requires occasional assistance, but is able to care for most of his/her needs.
* Female of childbearing potential demonstrates a negative urine pregnancy test, and agrees to remain abstinent or use two acceptable forms of birth control for at least 14 days prior to study, throughout the study, and at least 1 month following last dose of study drug.

Exclusion Criteria:

* Has vomited in the 24 hours prior to treatment Day 1
* Has symptomatic primary or metastatic symptomatic central nervous system malignancy causing nausea and/or vomiting
* Is scheduled to receive chemotherapy agent classified as highly emetogenic
* Has received or will receive total body irradiation, or radiation therapy to the abdomen, pelvis, head and neck in the week prior to Treatment Days 1 through Day 6 of the Treatment Period
* Has illness or history of illness which might confound study results or pose unwarranted risk
* Known history of QT interval prolongation
* Uses illicit drugs or abuses alcohol
* Mentally incapacitated or has a significant emotional or psychiatric disorder
* History of hypersensitivity to aprepitant, ondansetron or dexamethasone
* Pregnant or breast-feeding
* Has participated in a study with aprepitant or taken a non-approved (investigational) drug within the last 4 weeks
* Has concurrent condition, such as systemic fungal infection or uncontrolled diabetes, that precludes administration of dexamethasone.

Answer: C