NCT00062439|CompletedPhase 2ResultsDMC

S0220: Chemoradiotherapy Followed By Surgery and Docetaxel in Treating Patients With Pancoast Tumors

A Phase II Trial of Induction Chemoradiotherapy With Cisplatin/Etoposide Followed by Surgical Resection, Followed by Docetaxel, for Non-Small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumors)

SWOG Cancer Research Network ClinicalTrials.gov

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3 other identifiers

CDR0000304777U10CA032102S0220

Study Type

interventional

Target

Locations

1 country

Sites

154

Timeline

RegisteredJun 2003

StartedJul 2003

CompletionDec 2010

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, and docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining cisplatin and etoposide with radiation therapy may shrink the tumor so it can be removed by surgery. Giving docetaxel after surgery may kill any remaining tumor cells. PURPOSE: This phase II trial is studying how well giving chemoradiotherapy together with cisplatin and etoposide followed by surgery and docetaxel works in treating patients with newly diagnosed Pancoast tumors, a type of non-small cell lung cancer.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for phase_2 lung-cancer

Timeline

Completed

Started Jul 2003

Longer than P75 for phase_2 lung-cancer

Geographic Reach

1 country

154 active sites

Status

completed

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

7.4 years study duration

First Submitted

Initial submission to the registry

June 5, 2003

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2003

Completed

25 days until next milestone

Study Start

First participant enrolled

July 1, 2003

Completed

7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed

3 years until next milestone

Results Posted

Study results publicly available

November 25, 2013

Completed

Last Updated

November 25, 2013

Status Verified

October 1, 2013

Enrollment Period

7.4 years

First QC Date

June 5, 2003

Results QC Date

November 15, 2012

Last Update Submit

October 30, 2013

Conditions

Lung Cancer

Keywords

stage II non-small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

Feasibility of Treating Patients With Stage IIB/IIIB Pancoast Tumors With a Regimen of Cisplatin and Etoposide Plus Concurrent Radiotherapy Followed by Surgical Resection Followed by Consolidation Therapy With Docetaxel.
Feasibility was assessed by estimating the percentage of participants who would be able to complete the entire treatment regimen.
After completion of 5 weeks of radiotherapy given concurrently with cisplatin+etoposide, surgery + 8 weeks of recovery time, and 6 weeks of consolidation therapy with docetaxel

Secondary Outcomes (4)

Adverse Events
Weekly for the first 13 weeks, then every 3 weeks for the next 6 weeks.
Overall Survival
daily for 12 weeks then every 3 weeks for 12 weeks, then every 6 months thereafter.
Progression-Free Survival at 3 Years
At the completion of induction therapy, then again 4 weeks after the completion of consolidation therapy, then every 3 months for 2 years, then every 6 months until up to a maximum of 5 years after enrollment.
Response
After completion of induction therapy.

Study Arms (1)

Etoposide, Cisplatin, Thoracic RT, Surgery, Docetaxel

EXPERIMENTAL

Drug: cisplatinDrug: docetaxelDrug: etoposideProcedure: conventional surgeryRadiation: radiation therapy