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

NCT02001168 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2013-12-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Pemetrexed

Pemetrexed 500 mg/m2, d1, 21 d as a cycle.

DRUG

Docetaxel

Docetaxel 60mg/m2 d1＋Cis-platinum 60mg/m2, d1, 21 d as a cycle.

DRUG

rh-Endostatin

rh-Endostatin 7.5mg/m2 d1-14; 21 d as a cycle.

DRUG

Cis-platinum

Cis-platinum 60mg/m2, d1, 21 d as a cycle.

Sponsors & Collaborators

  • Xinjiang Medical University

    lead OTHER

Principal Investigators

  • Pang Zuoliang, Postgraduate · Cancer Hospital of Xinjiang Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2020-12-31
Completion
2022-10-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02001168 on ClinicalTrials.gov