NCT00006012|CompletedPhase 1

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

Phase I-II Study of Topotecan and Paclitaxel Followed by High-Dose Thoracic Radiation Therapy With Concomitant Cisplatin/Etoposide and Amifostine in Limited-Stage Small Cell Lung Cancer

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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2 other identifiers

NCCTG-N9923CDR0000068021

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredOct 2003

StartedFeb 2001

CompletionMay 2006

Brief Summary

RATIONALE: Drugs used in chemotherapy work in 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 with radiation therapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy before, during, and after 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 P75+ for phase_1

Timeline

Completed

Started Feb 2001

Longer than P75 for phase_1

Geographic Reach

1 country

84 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

5.2 years study duration

First Submitted

Initial submission to the registry

July 5, 2000

Completed

7 months until next milestone

Study Start

First participant enrolled

February 1, 2001

Completed

2.7 years until next milestone

First Posted

Study publicly available on registry

October 8, 2003

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed

Last Updated

July 6, 2016

Status Verified

July 1, 2016

Enrollment Period

5.2 years

First QC Date

July 5, 2000

Last Update Submit

July 1, 2016

Conditions

Drug/Agent Toxicity by Tissue/Organ Lung Cancer Radiation Toxicity

Keywords

drug/agent toxicity by tissue/organradiation toxicitylimited stage small cell lung cancer

Outcome Measures

Primary Outcomes (1)

Survival at 2 years
at 2 years

Secondary Outcomes (3)

Local progression-free survival at 2 years
at 2 years
Overall survival
Up to 5 years
Time to progression
Up to 5 years

Study Arms (1)

topotecan + paclitaxel + filgrastim + TRT + radiation

EXPERIMENTAL

Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 5. Patients receive filgrastim (G-CSF) subcutaneously (SC) daily beginning 24 hours after the last dose of chemotherapy and continuing until blood counts recover. Treatment repeats every 3 weeks for 2 courses. After 2 courses of treatment, patients undergo TRT twice daily for 5 consecutive days for 5 weeks. During TRT, patients receive cisplatin IV, oral etoposide, and amifostine SC daily prior to TRT. At 4 weeks after completion of TRT, patients receive 2 additional courses of topotecan, paclitaxel, and G-CSF every 3 weeks followed by prophylactic cranial irradiation. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.

Biological: filgrastimDrug: amifostine trihydrateDrug: cisplatinDrug: etoposideDrug: paclitaxelDrug: topotecan hydrochlorideRadiation: radiation therapy