NCT00003812|CompletedPhase 2

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

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

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

Compare

4 other identifiers

CALGB-39808U10CA031946CLB-39808CDR0000066958

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJul 2004

StartedMar 1999

CompletionMar 2006

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 more than one drug and giving them before and with radiation therapy may be an effective treatment for limited-stage small cell lung cancer. PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus 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 Mar 1999

Longer than P75 for phase_2 lung-cancer

Geographic Reach

1 country

48 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 years study duration

Study Start

First participant enrolled

March 1, 1999

Completed

8 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed

4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed

2 months until next milestone

First Posted

Study publicly available on registry

July 22, 2004

Completed

1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed

Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

5.3 years

First QC Date

November 1, 1999

Last Update Submit

July 19, 2016

Conditions

Lung Cancer

Keywords

limited stage small cell lung cancer

Outcome Measures

Primary Outcomes (2)

response rate
Up to 5 years
overall survival
Up to 5 years

Study Arms (1)

chemotherapy + radiation therapy

EXPERIMENTAL

Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 1. Filgrastim (G-CSF) is administered subcutaneously every day starting on day 6 until blood counts recover. The course is repeated once beginning on day 22. After restaging, patients begin thoracic radiotherapy daily, five days per week, for 6-7 weeks. On the same day that radiotherapy begins, patients receive carboplatin IV over 1 hour (day 43) and etoposide IV over 1 hour daily for 3 days (days 43-45). The consolidation chemotherapy is repeated every 21 days for a total of 3 courses. Patients with stable or responding disease undergo prophylactic cranial irradiation. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then at least every year.

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