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Table 1 Inclusion and exclusion criteria

From: A randomized phase II clinical trial of nab-paclitaxel and carboplatin compared with gemcitabine and carboplatin as first-line therapy in locally advanced or metastatic squamous cell carcinoma of lung

Inclusion criteria

• Previously untreated, histologically documented stage IIIB to stage IV or stage IIIA that is not amenable to regional therapy (7th Edition of TNM Staging Criteria) squamous cell carcinoma of lung. Previously untreated, histologically documented squamous cell carcinoma of lung with stage IV or locally advanced disease that is not amenable to radical regional therapy (7th Edition of TNM Staging Criteria).

• At least one measurable tumor lesion as defined by RECIST criteria.

• 18 to 85 years of age.

• ECOG performance status 0-1.

• Patients have no previously malignant tumors or history except cured cervical carcinoma in situ, basal cell carcinoma or superficial bladder cancer (Ta, Tis or T1).

• Patients should not have been treated with chemotherapy such as gemcitabine, platinum and taxane. But patients who have received chemotherapy for neoadjuvant or adjuvant treatment at least 12 months before the study treatment are eligible.

• Patients’ blood test must meet the following requirements:

o ANC ≥ 1.5 x 109/L

o Platelets ≥ 100 x 109/L

o Hb ≥ 90 g/L (9 g/dL)

• Patients’ clinical biochemistry examination must meet the following requirements:

o ALT and AST ≤ 2.5 x upper limit of normal (ULN) without liver metastasis, ALT and AST ≤ 5 x ULN with liver metastases

o Serum creatinine ≤ 1.5 x ULN

o Total bilirubin ≤ 1.5 x ULN

• Urine pregnancy test is negative for women, within 14 days before study treatment.

• Estimated life expectancy of at least 3 months.

• Patients will comply with the clinical trial protocol.

• Patients voluntarily participate in clinical trial and the informed consent must be signed.

Exclusion criteria

• Patients who are currently undergoing other anti-tumor therapies.

• Patients who were enrolled into any other clinical trial within 4 weeks of study entry.

• Any clinical laboratory findings give reasonable suspicion of a disease or condition that contraindicates the use of any study medication or render the subject at high risk from treatment.

• Primary brain tumor or central nervous system metastatic tumor.

• Serious mental disorder.

• Serious dysgnosia or cognitive dysfunction.

• Other serious comorbidities.

• Alcohol or drug dependence.

• Previously allergic to drugs used in the study.

 

• Patients who are deemed unsuitable to participate in the study