Please select the eligibility criteria that correspond to the clinical trial below.
Title: To Assess the Efficacy and Safety of Ramosetron, Aprepitant and Dexamethasone Therapy vs Ondansetron, Aprepitant and Dexamethasone Therapy for Preventing of Nausea and Vomiting in Highly Emetogenic Chemotherapy (ROAD Study)
Brief Summary: The purpose of this study is to assess the efficacy and safety of Ramosetron, Aprepitant and Dexamethasone therapy versus Ondansetron, Aprepitant and Dexamethasone therapy for preventing of nausea and vomiting in highly emetogenic chemotherapy (ROAD study):

Prospective multicenter, randomized, single blinded, phase III study.


Options:
A: DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed malignant disease

  * No head and neck cancer or upper gastrointestinal cancer
* Scheduled to receive a single day of moderately or highly emetogenic chemotherapy regimen (for ≤ 4 courses)

  * Chemotherapy administration ≤ 4 hours
  * Duration of each course ≤ 28 days
  * Causing nausea and vomiting in 30-100% of patients if untreated according to Hesketh algorithm
* Must be able to receive standardized doses of dexamethasone for the prevention of emesis during study treatment
* No greater than mild nausea or any vomiting within 24 hours before beginning study treatment

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known allergy or hypersensitivity to other selective 5-HT3 receptor antagonists or local anesthetics
* QTc interval ≤ 500 ms
* No cardiac abnormality predisposing the patient to arrhythmia
* No psychological problem that, in the opinion of the investigator, is severe enough to preclude study participation
* No recent history (i.e., ≤ 1 year) of alcohol or drug abuse
* No concurrent condition that, in the opinion of the investigator, could affect assessment of study medication or interfere with the nausea/vomiting response (e.g., severe renal or hepatic impairment)

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No radiotherapy 7 days prior to, during, and 5 days after completion of study treatment
* More than 7 days since prior chemotherapy
* More than 7 days since prior and no concurrent prohibited medications (e.g., CYP3A4 inhibitors or other antiemetic medications)
* More than 7 days since prior antinausea medications
* More than 30 days since prior treatment on an investigational trial
* No other concurrent corticosteroids or dexamethasone at a different dose than study treatment
* No concurrent use of APF530, palonosetron hydrochloride, or aprepitant as rescue medications
B: Inclusion Criteria:

Cycle 1:

* Patient is scheduled to receive his/her first course of cisplatin chemotherapy at a dose of at least 70 mg/m\^2 administered a maximum of 3 hours
* Patient has a predicted life expectancy of at least 3 months
* Patient is not pregnant

Cycle 2 (optional):

* Participation in the study during the next cycle of chemotherapy is considered

appropriate by the investigator and will not pose unwarranted risk to the patient.

* Satisfactory completion of the preceding cycle of chemotherapy and related

study procedures.

* Patient will continue to receive the same chemotherapy regimen as in Cycle 1. The cisplatin dose may be reduced in subsequent cycle, as long as the new

dose is still no less than 70 mg/m\^2.

Exclusion Criteria:

Cycles 1 \& 2:

* Patient will receive stem cell therapy in conjunction with cisplatin
* Patient has an active infection or any uncontrolled disease (e.g. diabetes)
* Patient will receive multiple-day chemotherapy with cisplatin
* Patient will receive chemotherapy of moderate or high emetogenicity on the 6 days prior to cisplatin infusion or the 6 days following the cisplatin infusion
* Patient has vomited within 24 hours prior to cisplatin infusion
* Patient received or will receive radiation therapy to the abdomen
C: Inclusion Criteria:

1. Patients diagnosed as malignancy who will be treated with highly emetogenic chemotherapeutic agents (NCCN guideline v1.0 2011 anti-emesis), over 20 years and both sex
2. ECOG performance status 0-2
3. Available oral administration of study drugs
4. Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital

Exclusion Criteria:

1. Severe Hypertension, severe Heart disease, kidney disease (serum creatinine \> 3 mg/dl), liver disease (AST, ALT \> 3 times of upper normal range, ALP \> 2 times of upper normal range)
2. Patients with GI obstruction, active gastric ulcer or other diseases that could provoke nausea and vomiting
3. Patients who have nausea and vomiting within 1 week before chemotherapy
4. Patients who should take steroid, antiemetics, pimozide, terfenadine, astemizole, cisapride, rifampin, carbamazepine, phenytoin, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir or nelfinavir for the treatment of other diseases
5. Patients with brain tumor, brain metastasis or seizure
6. Patients receiving chemotherapy within 12 months before enrollment
7. Patients who need radiation therapy during study period or receiving radiation therapy within 2 weeks before chemotherapy
8. Patients who have known allergy or severe side effect on study drugs
9. Pregnant or lactating women, or women who wish to become pregnant
10. Others whom the investigator judges inappropriate as subjects for this study
D: Inclusion Criteria:

* 18 years of age or older, of either gender, and of any race
* Has never been treated with cisplatin and is to receive the first course of cisplatin-based chemotherapy (≥60 mg/m2)
* Karnofsky performance score of ≥60
* Predicted life expectancy of ≥4 months
* Adequate bone marrow, kidney, and liver function

Exclusion Criteria:

* Contraindication to cisplatin, granisetron, or dexamethasone
* Is pregnant or breast feeding
* Has previously received cisplatin or subject is planning to receive multiple days of cisplatin in a single cycle
* 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 4 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, pemetrexed)
* 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 cisplatin-based chemotherapy on Day 1 in Cycle 1.

Answer: C