NCT00072527|CompletedPhase 2

Cisplatin and Irinotecan Followed by Carboplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

Induction Cisplatin/Irinotecan Followed By Combination Carboplatin, Etoposide And Chest Radiotherapy In Limited Stage Small Cell Lung Cancer: A Phase II Study

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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3 other identifiers

CALGB-30206U10CA031946CDR0000339871

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredNov 2003

StartedNov 2003

CompletionJan 2013

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, irinotecan, carboplatin, and etoposide, 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 with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of cisplatin and irinotecan followed by carboplatin, etoposide, 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 Nov 2003

Longer than P75 for phase_2 lung-cancer

Geographic Reach

1 country

76 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

9.2 years study duration

Study Start

First participant enrolled

November 1, 2003

Completed

3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2003

Completed

1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2003

Completed

3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed

5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed

Last Updated

July 6, 2016

Status Verified

July 1, 2016

Enrollment Period

3.6 years

First QC Date

November 4, 2003

Last Update Submit

July 1, 2016

Conditions

Lung Cancer

Keywords

limited stage small cell lung cancer

Outcome Measures

Primary Outcomes (1)

Efficacy, in terms of survival, at 2 years after initiation of study treatment

Secondary Outcomes (6)

Overall response rate as measured by RECIST at completion of study treatment
Overall survival
Failure-free survival
Response rate as measured by RECIST after completion of 2 courses of induction chemotherapy
Toxicity as measured by NCI CTCAE v.30 after completion of 2 courses of chemotherapy
+1 more secondary outcomes

Study Arms (1)

Induction and consolidation chemotherapy

EXPERIMENTAL

Induction chemotherapy (Cycles 1 and 2): Patients receive cisplatin 30 mg/m\^2 on days 1, 8, 22 and 29 and irinotecan 65 mg/m\^2 on days 1, 8, 22 and 29 for cycles 1 and 2. Consolidation chemotherapy (Cycles 3, 4 and 5 beginning on day 43, week 7): Patients receive carboplatin on days 43, 64 and 85, etoposide 100 mg/m\^2 IV on days 43-45, 64-66 and 85-87 and XRT 5 fractions/week starting on day 43

Drug: carboplatinDrug: cisplatinDrug: etoposideDrug: irinotecan hydrochlorideRadiation: radiation therapy