Study of Etoposide, Cisplatin, and Radiotherapy Versus Paclitaxel, Carboplatin and Radiotherapy to Treat Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luhua Wang, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01494558
First received: December 14, 2011
Last updated: December 16, 2011
Last verified: December 2011
  Purpose

Cisplatin-based combination chemotherapy given concurrently with radiotherapy is the standard of care for patients with inoperable stage III NSCLC. The most common chemotherapeutic agents used concurrently with radiotherapy have been vinorelbine, vinblastine, and etoposide in conjunction with cisplatin or weekly paclitaxel and carboplatin. No randomized phase III trials of concurrent chemoradiotherapy have shown the superiority of one chemotherapy regimen over another. The clinical trial is to compare radiotherapy concurrently with PE (etoposide and cisplatin) and PC (paclitaxel and carbplatin) for local advanced NSCLC (stage IIIA/IIIB). It is a randomized, multicenter, open labeled phase III clinical trial. All patients receive conformal radiotherapy or intensity modulated radiotherapy with conventional fraction. The chemotherapy regimens are PE (etoposide 50mg/m2 d1-5, 29-33 and cisplatin 50mg/m2 d1,8,29 and 36 29-33 ) and PC (paclitaxel 45mg/m2 weekly over 1hour and carbplatin AUC =2mg/mL/min over 30min weekly). The primary purpose is to evaluate objective response rate, complications, progression-free survival, overall survival. The second purpose is to evaluate quality of life and cost.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Other: Chemoradiotherapy Regimen between PC and PE
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3 Study of Etoposide, Cisplatin, and Radiotherapy Versus Paclitaxel, Carboplatin and Radiotherapy in Patients With Unresectable Locally Advanced, Stage III Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: May 2007
Study Completion Date: August 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PE concurrent chemotherapy
Radiotherapy concurrently with PE chemotherapy
Other: Chemoradiotherapy Regimen between PC and PE
etoposide 50mg/m2 d1-5, 29-33 and cisplatin 50mg/m2 d1,8,29 and 36 29-33 during radiotherapy paclitaxel 45mg/m2 weekly and carbplatin AUC =2mg/mL/min weekly during radiotherapy
Other Name: Chemoradiotherapy
Active Comparator: PC concurrent chemotherapy
Radiotherapy concurrently with PC chemotherapy
Other: Chemoradiotherapy Regimen between PC and PE
etoposide 50mg/m2 d1-5, 29-33 and cisplatin 50mg/m2 d1,8,29 and 36 29-33 during radiotherapy paclitaxel 45mg/m2 weekly and carbplatin AUC =2mg/mL/min weekly during radiotherapy
Other Name: Chemoradiotherapy

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Inoperable stage IIIA/IIIB NSCLC proved by pathology or cytology
  2. Age 18 to 75, ECOG ≤ 2, lose weight <10% during 6 months
  3. No serious diseases of important organs
  4. Chest CT in recently 4 weeks
  5. No other tumor disease except stage I cervical cancer or cutaneous basal cell carcinoma
  6. Sign consent
  7. Measurable lesion

Exclusion Criteria:

  1. Pretreatment radiotherapy or chemotherapy
  2. Pregnant or lactation woman
  3. Serious diseases (include uncontrolled diabetes and infection) of important organs
  4. Psychopath
  5. Join in other clinical trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01494558

Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
Principal Investigator: luhua Wang, MD Department of Radiation Oncology, Cancer Hospital & Institution, CAMS & PUMC
  More Information

No publications provided

Responsible Party: Luhua Wang, Chairman of Thoracic Group, Clinical Professor, Radiation Oncology Department, Cancer Hospital&Institute, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01494558     History of Changes
Other Study ID Numbers: 2006BAI02A02[1]-03
Study First Received: December 14, 2011
Last Updated: December 16, 2011
Health Authority: China:Chinese Academy of Medical Sciences

Keywords provided by Chinese Academy of Medical Sciences:
Overall survival

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Cisplatin
Etoposide
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014