Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Early Stages NSCLC

NCT00191126 | Completed Phase 3 DMC

• 2 other identifiers: 3532B9E-MC-S132
• Study Type: interventional
• Target: 263
• Locations: 15 countries
• Sites: 37

Brief Summary

Preoperative chemotherapy is considered to play a role in early stage non small cell lung cancer (NSCLC) .The use of preoperative Cisplatin/Gemcitabine chemotherapy has proven feasible and without excessive morbidity or mortality in the Phase II setting. The aim of the present Phase III study is to determine whether 3 cycles of preoperative chemotherapy with Cisplatin/Gemcitabine improves progression free survival of NSCLC patients versus surgery alone. Postoperative chemotherapy will not be utilized in this Phase III trial.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  baseline to measure progressive disease

Secondary Outcomes (4)

• To compare the survival and sites of relapse in the two study arms.

  baseline to progressive disease

• Pharmacology toxicity

  every cycle

• Response rate

  baseline to measured progressive disease

• Pathologic response rate of tissue samples

  baseline, post chemotherapy, post surgery

Study Arms (2)

A

OTHER

Procedure: surgery

B

EXPERIMENTAL

Drug: gemcitabine; Drug: Cisplatin; Procedure: surgery

Interventions

gemcitabine DRUG

1250 mg/m2, IV, day 1 and 8, q 21 days x 3 cycles

Also known as: LY188011, Gemzar

B

Cisplatin DRUG

75 mg/m2, IV, q 21 days x 3 cycles

B

surgery PROCEDURE

surgery

A; B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have pathologic documentation of non-small cell lung cancer, IB, II, IIIA.
• ECOG Performance Status of 0 - 1
• Bidimensionally measurable disease or evaluable disease
• Adequate organ function

You may not qualify if:

• Have greater than Grade 1 neuropathy - motor/sensory
• Significant history of cardiac disease
• Pleural effusion

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (37)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician.

Leuven, Belgium

Location

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Liège, Belgium

Location

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Sarajevo, Bosnia and Herzegovina

Location

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Sofia, Bulgaria

Location

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Varna, Bulgaria

Location

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Cairo, Egypt

Location

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Tallinn, Estonia

Location

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Großhansdorf, Germany

Location

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Löwenstein, Germany

Location

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Nuremberg, Germany

Location

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Ulm, Germany

Location

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Pécs, Hungary

Location

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Bologna, Italy

Location

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Chieti, Italy

Location

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L’Aquila, Italy

Location

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Milan, Italy

Location

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Napoli, Italy

Location

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Padua, Italy

Location

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Perugia, Italy

Location

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Pisa, Italy

Location

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Roma, Italy

Location

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Siena, Italy

Location

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Teramo, Italy

Location

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Torino, Italy

Location

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Verona, Italy

Location

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Kaunas, Lithuania

Location

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Klaipedos, Lithuania

Location

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Vilnius, Lithuania

Location

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Warsaw, Poland

Location

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Bucharest, Romania

Location

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Cluj-Napoca, Romania

Location

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Riyadh, Saudi Arabia

Location

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Bratislava, Slovakia

Location

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Košice, Slovakia

Location

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Helsingborg, Sweden

Location

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Malmo, Sweden

Location

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Taichung, Taiwan

Location

Related Publications (1)

• Scagliotti GV, Pastorino U, Vansteenkiste JF, Spaggiari L, Facciolo F, Orlowski TM, Maiorino L, Hetzel M, Leschinger M, Visseren-Grul C, Torri V. Randomized phase III study of surgery alone or surgery plus preoperative cisplatin and gemcitabine in stages IB to IIIA non-small-cell lung cancer. J Clin Oncol. 2012 Jan 10;30(2):172-8. doi: 10.1200/JCO.2010.33.7089. Epub 2011 Nov 28.

  PMID: 22124104 RESULT

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gemcitabine; Cisplatin; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: September 1, 2000
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: September 12, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

BE (2); DE (4); ES (1); EG (1); IT (13); RO (2); PL (1); SA (1); BU (2); BO (1); HU (1); LI (3); SE (2); TW (1); SL (2)