NCT00033696|CompletedPhase 2

Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

Paclitaxel/Topotecan/Etoposide (EtopoTax) Induction Followed by Consolidation Chemoradiotherapy for Limited Stage Small Cell Lung Cancer: A Phase II Study

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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4 other identifiers

CALGB-30002U10CA031946CLB-30002CDR0000069313

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJan 2003

StartedSep 2001

CompletionApr 2009

Brief Summary

RATIONALE: Drugs used in chemotherapy 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 chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have limited-stage 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 P50-P75 for phase_2 lung-cancer

Timeline

Completed

Started Sep 2001

Longer than P75 for phase_2 lung-cancer

Geographic Reach

1 country

51 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

7.6 years study duration

Study Start

First participant enrolled

September 1, 2001

Completed

7 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2002

Completed

10 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed

2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed

Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

5.3 years

First QC Date

April 9, 2002

Last Update Submit

July 15, 2016

Conditions

Lung Cancer

Keywords

limited stage small cell lung cancer

Outcome Measures

Primary Outcomes (1)

overall response rate
up to 5 years

Secondary Outcomes (2)

failure-free survival
up to 5 years
overall survival
up to 5 years

Study Arms (1)

chemotherapy + radiation therapy

EXPERIMENTAL

Induction therapy: Patients receive paclitaxel IV over 3 hours on days 1 and 22, oral topotecan on days 2-4 and 23-25, and oral etoposide on days 5-7 and 26-28. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on days 8 and 29 and continuing until blood counts recover. Consolidation therapy: Patients receive carboplatin IV over 1 hour on days 43, 64, and 85 and etoposide IV over 1 hour on days 43-45, 64-66, and 85-87. Patients undergo radiotherapy daily 5 days per week beginning on day 43 and continuing for 6-7 weeks. Patients with rapid disease progression discontinue study therapy. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

Biological: filgrastimDrug: carboplatinDrug: etoposideDrug: paclitaxelDrug: topotecan hydrochlorideRadiation: radiation therapy