Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Prospective Randomized Multicenter Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients
Brief Summary: Some cancer patients starting a new chemotherapy regimen are likely to develop blood clots, also known as venous thromboembolism (VTE). Blood clots can cause symptoms and can occasionally be life-threatening. The purpose of this study is to determine if a daily injection of a blood-thinner, dalteparin, for 12 weeks can safely and effectively reduce the frequency of blood clots. Dalteparin is currently approved for prevention of blood clots following surgery and in hospitalized patients but not specifically for cancer outpatients.


Options:
A: Inclusion Criteria:

Patients with completely resected non-small cell lung cancer of stage I, II, or IIIA T3N1 confirmed by histology can be included in the study Patients who had preoperative chemotherapy, those who are selected for adjuvant chemotherapy and those who are not candidates for adjuvant chemotherapy (because they have a contraindication to chemotherapy or they have a stage I cancer) are eligible for the study Written informed consent age \> 18 years

Exclusion Criteria:

Previous heparin induced thrombocytopenia Allergy to tinzaparin Allergy to sulfites Renal failure with a creatinin clearance \< 30 ml/min according to COCKROFT formula Prothrombin time \< 50% Platelet count \< 100 G/L Increased bleeding risk: ongoing hemorrhage, major bleeding within 10 days, previous intracerebral bleeding, uncontrolled hypertension (SAP \> 180 mmHg or DAP \> 120 mmHg) Indication for curative anticoagulant treatment on inclusion More than 6 weeks between surgery and inclusion Known pregnancy or no efficient contraception for women of childbearing age Breast feeding Previous malignant disease diagnosed within 2 years except in situ carcinoma of the uterine cervix or spinal-cellular or baso-cellular cutaneous carcinoma Inclusion in another therapeutic trial at the time of inclusion Treatment with an experimental drug within 30 days before inclusion in the study
B: 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
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:

* Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative therapies do not exist. Eligible malignancies include:

  * Adenocarcinoma of the pancreas (locally advanced or metastatic)
  * Colorectal (stage IV)
  * Non-small cell lung (unresectable stage III or IV)
  * Relapsed ovarian or stage IV
  * Surgically unresectable or metastatic gastric adenocarcinoma
* First or second line therapy (within 4 weeks of initiating therapy).
* Minimum age 18 years
* Life expectancy of greater than 6 months
* ECOG Performance Status 0, 1, or 2 (Karnofsky 60% or greater).
* Participants must have normal organ and marrow function as outlined in the protocol.

Exclusion Criteria:

* Participants may not be receiving any other study agents.
* Known brain metastases should be excluded from this clinical trial because of their poor prognosis and higher potential for intracranial hemorrhage.
* Prior history of documented venous thromboembolic event or pulmonary embolism within the last 5 years years (excluding central line associated events whereby patients completed anticoagulation \> 3 months previously)
* Active bleeding or high risk for bleeding (e.g. known acute gastrointestinal ulcer)
* Any history of significant hemorrhage (requiring hospitalization or transfusion) outside of a surgical setting within the last 5 years
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to enoxaparin or heparin.
* History of heparin-induced thrombocytopenia
* Presence of coagulopathy (PT or PTT\> 1.5 x upper limit of normal)
* Familial bleeding diathesis
* Known diagnosis of disseminated intravascular coagulation
* Currently receiving anticoagulant therapy
* Current use of aspirin (\>81mg daily), Clopidogrel (Plavix), cilostazol (Pletal), aspirin-dipyridamole (Aggrenox), or regular use of non-steroidal anti-inflammatory agents more than twice weekly. Maximum dose of ibuprofen is 400mg no more than twice per week.
* Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Answer: B