Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prevention of Venous and Arterial Thromboembolism, in Cancer Patients Undergoing Chemotherapy, With a Low Molecular Weight Heparin (Nadroparin Calcium). A Randomized, Placebo-controlled, Double-blind, Multicenter Phase III Study.
Brief Summary: In this phase III, multicenter study, 1200 patients with lung, breast, gastrointestinal (stomach, colon-rectum, pancreas), ovarian or head and neck cancer undergoing chemotherapy will be randomly assigned (at the beginning of cytotoxic therapy) in a 2:1 ratio and in double-blind conditions to a treatment with subcutaneous low molecular weight heparin (nadroparin calcium, one injection/day) or placebo for the overall duration of chemotherapy or up to a maximum of 4 months (+/- 10 days).


Options:
A: Inclusion Criteria:

* A histologic diagnosis of malignancy;
* At planned initiation of a new systemic chemotherapy regimen (including patients starting on first chemotherapy or patients previously treated but starting on a new regimen);
* A risk score for VTE ≥3 \[assign score of 2 for very high risk sites of cancer (stomach, pancreas), score of 1 for high risk site (lung, lymphoma, gynecologic, bladder, testicular) and score of 0 for all other sites\], hemoglobin \<10 g/dL or planned use of erythropoiesis stimulating agents, platelet count ≥350,000/mm3, total leukocyte count \> 11,000/mm3 or body mass index ≥ 35 kg/m2\]. Any counts meeting criteria drawn within 2 weeks prior to enrollment are considered acceptable.
* Age 18 years or older
* Provide written, informed consent.

Exclusion Criteria:

* Active bleeding or at high risk of serious bleeding complication in the opinion of the investigator
* Diagnosis of primary brain tumor multiple myeloma, leukemia, or myelodysplastic syndrome
* Planned stem cell transplant
* Life expectancy \< 6 months
* Known allergy to heparin or LMWH
* Patient or caregiver incapable of daily self-injection
* Acute or chronic renal insufficiency with creatinine clearance \< 30 mL/min
* History of heparin-induced thrombocytopenia
* Allergy to contrast agents
* Pregnancy
* Need for anticoagulant therapy
* Platelet count \< 75,000/mm3
B: DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the pancreas

  * Metastatic disease
  * Not amenable to treatment
  * No localized or locally advanced disease
* Measurable disease (metastatic or primary tumor) defined as ≥ 2 cm by CT scan or ≥ 1 cm by spiral CT scan or MRI
* No progressive thrombo-embolic disease
* No adenocarcinoma of the biliary tract or ampulla of Vater
* No known CNS metastases

PATIENT CHARACTERISTICS:

* WHO performance status 0-2
* Life expectancy \> 12 weeks
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL
* Alkaline phosphatase \< 5 times normal
* Bilirubin \< 1.5 times normal
* Creatinine \< 1.5 times normal
* Creatinine clearance \< 30 mL/min
* Pain controlled or stabilized via analgesic therapy
* Affiliation with social security system
* Not pregnant or nursing
* No controlled or uncontrolled jaundice
* No contraindication to study drugs
* No cardiovascular accident (myocardial infarction, cerebral vascular accident) within the past 6 months
* No serious cardiac and/or respiratory disease
* No other cancer in the past 5 years except the following cancers, provided they have been completely resected:

  * Skin cancer
  * Localized melanoma
  * Carcinoma in situ of the cervix
* No history of thrombophilia
* No history of heparin-induced thrombocytopenia
* No uncontrolled or persistent hypercalcemia
* No psychological, familial, social, and/or geographical condition that precludes participation in the study

PRIOR CONCURRENT THERAPY:

* No prior hematologic therapy for metastatic disease
* No prior abdominal radiotherapy
* No concurrent corticosteroids as anti-emetic therapy
* No other concurrent anticoagulation
C: INCLUSION CRITERIA:

* both sexes;aged\>18 years;
* suffering from different types of malignancies(lung, breast,gastric,colon- rectum,pancreatic,ovarian,head and neck cancer)undergoing systemic chemotherapy,
* having signed Informed Consent prior to initiation of any study procedure.

EXCLUSION CRITERIA:

* adjuvant and neo-adjuvant chemotherapy;
* objectively confirmed venous or arterial thromboembolism in the last three months;
* antithrombotic treatment for other indications;
* life expectancy of less than 3 months;
* Performance Status\>2(ECOG);
* active bleeding or bleedings in the last four weeks requiring hospitalization,transfusion or surgical intervention;
* bleeding diathesis(prothrombin time\<70% or activated partial thromboplastin time ratio\>1.3),or platelet count\<50x10\^9/L;
* cerebrovascular hemorrhage in the last six months;
* known active gastric or duodenal ulcer;
* known cerebral metastasis;
* cerebral aneurysm;
* III-IV grade diabetic retinopathy;
* severe and uncontrolled hypertension(systolic blood pressure\>180 mmHg or diastolic blood pressure\>110 mmHg);
* chronic atrial fibrillation;
* acute endocarditis;
* acute pancreatitis;
* known hypersensitivity to unfractionated heparin or LMWH;
* previous occurrence of heparin-induced thrombocytopenia;
* renal impairment (dependent on dialysis or creatinine higher than 2.5mg%);
* liver insufficiency (alanine aminotransferase,aspartate aminotransferase,alkaline phosphatase levels\>3 times the upper limit of the normal ranges and/or total bilirubin \>3.0 mg/ml);
* pregnancy or childbearing potential without adequate contraception;
* treatment with other investigational drugs or patient inclusion in other clinical trials;
* patients who are unable to fulfill the study requirements in terms of visits/compliance to treatment.
D: Inclusion Criteria:

* histological or cytological pancreatic carcinoma, stage IV A, b
* no preceding radio or chemotherapy of the primarius or the reference lesions
* Karnofsky performance status ≥ 60%
* measurable tumor lesion by spiral CT or MRT not older than 14 days
* no deep venous thrombosis within the last 2 years
* patient compliance and geographical proximity of the residence, which make an adequate follow up possible
* sufficient bone marrow reserve: leukocyte ≥ 3.5 × 109 /l, thrombocyte ≥ 100 × 109 /l
* signed informed consent
* minimum age of 18 years
* women/men must provide sufficient pregnancy prevention

Exclusion Criteria:

* preexisting indication for anti-coagulation of other reason
* bleeding in the last 2 weeks or increased bleeding risk (e.g. serious coagulating disturbance, active stomach or intestine ulzera, or had operational interferences in the last 2 weeks)
* body weight \< 45 kg and/or \> 100 kg
* pregnancy or insufficient preventing methods in the study process
* serious illness, which are incompatible with a study participation
* hypersensitivity to study drugs
* patients with serious kidney malfunction (Creatininclearance \< 30 ml/min)

Answer: C