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NCT Number: NCT01733589

Recombinant Human Endostatin Continued Pumping Into Vein Combining With CCRT in Unresectable Stage III NSCLC

Resistance of hypoxic tumor cells to radiation is a significant reason of failure in the local control of tumors, especially the squamous cell carcinomas. Preclinical models have shown that Endostar may transiently "normalize" the tumor vasculature to make it more efficient for oxygen delivery, thereby providing a window of opportunity for enhanced sensitivity to radiation treatment. This study is to evaluate the safety, toxicity, and efficacy of the addition of Endostar Continued Pumping into Vein to the standard CCRT regimen in patients with unresectable stage III NSCLC.

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Key information

Conditions

Stage III Non-small-cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

About this study

Primary

Evaluate the efficacy and safety of Endostar combined with concurrent chemo-radiotherapy (CCRT) in patients with unresectable stage III non-small-cell lung cancer (NSCLC).

Secondary

Measure changes in VEGF and other angiogenic cytokines and antiangiogenic factors in plasma samples from these patients.

Evaluate the application of CT perfusion imaging to determine changes in tumor vascular mophology and function during treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • untreated histologic or cytologic of NSCLC verified
  • inoperable stage IIIA or IIIB NSCLC
  • measurable disease by RECIST
  • 18~70 years of age
  • an ECOG PS of 0 to 1
  • absolute neutrophil count (ANC) of ≥1500/μL, hemoglobin ≥10gm/dL, platelet ≥100,000/μL
  • serum creatinine ≤1.25 times of upper limit of normal (ULN), calculated creatinine clearance (CrCl) of ≥60ml/min
  • bilirubin 1.5×ULN, AST and ALT less than 2.5×ULN, alkaline phosphatase less than 5×ULN
  • forced vital capacity in 1 second (FEV1) higher than 0.8 L
  • CB6 is normal
  • Written informed consent

Exclusion criteria

  • a history of other malignant diseases
  • any contraindications for chemoradiotherapy
  • distant metastasis
  • malignant pleural and/or pericardial effusion
  • pregnant or nursing
  • preexisting bleeding diatheses or coagulopathy

Treatment and study plan

Recombinant human endostatin

Drug

Recombinant human endostatin(7.5mg/m2/24h) Continued Pumping Into Vein through 5 days at week 1, 3, 5, and 7,combined with concurrent chemo-radiotherapy.

Etoposide (50mg/m2) IV (in the vein) on day 1 to day 5 of a 28-day cycle for 2 cycles

Drug

cisplatinum (50mg/m2) IV (in the vein) on day 1 and day 8 of a 28-day cycle for 2 cycles

Drug

laboratory biomarker analysis

Other

CT perfusion imaging

Other

Primary outcomes

  1. progression-free survival

    Time frame: 2-year

    from beginning treatment to progressive disease or the last follow-up

Secondary outcomes

  1. Response rate

    Time frame: 1 month

    complete response(CR); partial response(PR); stable disease(SD); progressive disease(PD)

  2. overall survival

    Time frame: 5 years

    from date of beginning treatment until date of death

  3. treatment related toxicities

    Time frame: 3 months

    radiation-induced esophagitis; radiation-induced pneumonia

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Collaborators

  • Chinese Academy of Medical Sciences
  • Fudan University
  • Fujian Cancer Hospital
  • Jiangsu Cancer Institute & Hospital
  • Peking University Cancer Hospital & Institute
  • Shandong Cancer Hospital and Institute
  • The First People's Hospital of Lianyungang
  • Tianjin Medical University Cancer Institute and Hospital

Registry information

Official study title

Multicenter Phase I/II Clinical Trial of Recombinant Human Endostatin Continued Pumping Into Vein Combining With Concurrent Chemo-Radiotherapy in the Patients With Unresectable Stage III Non-small-Cell Lung Cancer

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 27, 2012
Registry last updated
Jul 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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