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

December 16, 2011 updated by: Luhua Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Chemoradiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Principal Investigator: luhua Wang, MD, Department of Radiation Oncology, Cancer Hospital & Institution, CAMS & PUMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

December 14, 2011

First Submitted That Met QC Criteria

December 16, 2011

First Posted (Estimate)

December 19, 2011

Study Record Updates

Last Update Posted (Estimate)

December 19, 2011

Last Update Submitted That Met QC Criteria

December 16, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006BAI02A02[1]-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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