Comparison of Postoperative Adjuvant Chemotherapy With/Without Rh-endostatin on Non-small Cell Lung Cancer in PhaseⅠB

• Status: Active, not recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

• Lung cancer is one of causes of the malignant tumor-associated death on a global scale, in which the surgery is the only effective approach in patients with non-small cell lung cancer (NSCLC). As present, the total postoperative 5-year survival rate of NSCLC is 40%, while only 4%～15% patients can benefit from adjuvant chemotherapy[1]. American National Comprehensive Cancer Network (NCCN) manual recommends that adjuvant chemotherapy can be performed on NSCLC patients in phase Ⅱ～ⅢA.

• In order to assure the necessity of adjuvant chemotherapy on NSCLC patients in phase ⅠB or which kind of patients would benefit from it after the establishment of new staging, a multi-subject group of lung cancer set up a perspective, randomized, open clinical trial to explore whether adjuvant chemotherapy was effective on NSCLC patients in phase ⅠB under new staging policy, and to collect the characteristics of patients who could benefit from the treatment and the better adjuvant drugs after operation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xinjiang Medical University
• Treatments: Cisplatin; Docetaxel; Endostatins; Pemetrexed

Criteria

Inclusion Criteria:

• Patients who are diagnosed with NSCLC pathologically and T stage is T2a in postoperative pathological staging. No lymph node and distant metastasis are observed and the surgical methods include wedge incision, segmentectomy of right lung or lobe.

• Age: 18～70 years

• ECOG PS score: 0-1 score

• patients who are diagnosed with the high risk factors as follows: poor differentiation (including low differentiation, undifferentiation and neuro-endocrine differentiation), blood vessel invasion, wedge incision, tumor diameter >4 cm, visceral pleura involvement, incomplete clear of lymph node and incisal edge <1.0 cm.

• Patients who are diagnosed without tumor recurrence before adjuvant chemotherapy.

• Informed consent is signed.

Exclusion Criteria:

• Patients with unexpected pathological patterns or those have received new adjuvant chemotherapy.

• Patients with other active malignant tumor history beside NSCLC before treatment except non-melanoma skin cancer, primary cervical cancer and cured early prostate cancer.

• Patients who are with chemotherapeutic contraindications, such as white blood count <4.0×109/L, blood platelet count <80×109/L or severe anemia (Hb<80 g/L); obvious liver dysfunction (increased transaminase or bilirubin >2.5 folds of normal level); un-manageable hypertension, diabetes, arrhythmia, repeated heart failure and chronic obstructive pulmonary diseases that could influence ventilation function; active stage of diseases infected by bacteria, fungi and virus; or patients who are in pregnancy and lactation periods.

• Patients who are un-recovered and poor with chemotherapy after 8-week treatment, or have received above 8-week treatment before treatment.

• Patients who are in poor obedience or other improper symptoms.