NCT00113386|TerminatedPhase 3ResultsDMC

Study Stopped

This study terminated early due to low accrual.

Cisplatin and Docetaxel With or Without Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Newly Diagnosed Stage III Non-Small Cell Lung Cancer

Phase III Randomized Trial of Preoperative Chemotherapy Versus Preoperative Concurrent Chemotherapy and Thoracic Radiotherapy Followed by Surgical Resection and Consolidation Chemotherapy in Favorable Prognosis Patients With Stage IIIA (N2) Non-Small Cell Lung Cancer

Radiation Therapy Oncology Group ClinicalTrials.gov

Compare

6 other identifiers

RTOG-0412CDR0000429479SWOG-S0332CALGB-RTOG-0412ECOG-RTOG-0412NCCTG-RTOG-0412

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJun 2005

StartedApr 2005

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Cisplatin and docetaxel may make tumor cells more sensitive to radiation therapy. Giving more than one drug (combination chemotherapy) together with radiation therapy before surgery may shrink the tumor so it can be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving cisplatin and docetaxel together with radiation therapy is more effective than giving cisplatin together with docetaxel in treating non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying cisplatin, docetaxel, and radiation therapy to see how well they work compared to cisplatin and docetaxel in treating patients who are undergoing surgery for newly diagnosed stage III non-small cell lung cancer.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3 lung-cancer

Geographic Reach

1 country

76 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2005

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2005

Completed

3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed

3.9 years until next milestone

Results Posted

Study results publicly available

December 27, 2012

Completed

Last Updated

June 28, 2013

Status Verified

June 1, 2013

Enrollment Period

3.8 years

First QC Date

June 7, 2005

Results QC Date

November 27, 2012

Last Update Submit

June 21, 2013

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung canceradenocarcinoma of the lunglarge cell lung cancersquamous cell lung cancerbronchoalveolar cell lung cancer

Outcome Measures

Primary Outcomes (1)

Comparison of Overall Survival
Date of death or date of last follow-up

Study Arms (2)

Induction chemotherapy, surgery, consolidation chemotherapy

OTHER

Induction/surgery/consolidation

Biological: filgrastimBiological: pegfilgrastimDrug: cisplatinDrug: docetaxelProcedure: adjuvant therapyProcedure: conventional surgeryProcedure: neoadjuvant therapy

Chemotherapy and radiation, surgery, consolidation ch

OTHER

Induction/radiation/surgery/cosolidation

Biological: filgrastimBiological: pegfilgrastimDrug: cisplatinDrug: docetaxelProcedure: adjuvant therapyProcedure: conventional surgeryProcedure: neoadjuvant therapyRadiation: radiation therapy