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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

December 14, 2011
December 16, 2011
May 2007
October 2010   (final data collection date for primary outcome measure)
Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01494558 on ClinicalTrials.gov Archive Site
Progression Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Etoposide, Cisplatin, and Radiotherapy Versus Paclitaxel, Carboplatin and Radiotherapy to Treat Non-Small Cell Lung Cancer
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

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
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: PE concurrent chemotherapy
    Radiotherapy concurrently with PE chemotherapy
    Intervention: Other: Chemoradiotherapy Regimen between PC and PE
  • Active Comparator: PC concurrent chemotherapy
    Radiotherapy concurrently with PC chemotherapy
    Intervention: Other: Chemoradiotherapy Regimen between PC and PE
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
August 2011
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01494558
2006BAI02A02[1]-03
Yes
Luhua Wang, Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
Not Provided
Principal Investigator: luhua Wang, MD Department of Radiation Oncology, Cancer Hospital & Institution, CAMS & PUMC
Chinese Academy of Medical Sciences
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP