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CompletedPhase 1 / Phase 2NCT00006012
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedfilgrastim and amifostine trihydrate

Plus 5 other study approaches.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 6, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?84 U.S. locations

Locations may change over time.

Who runs it?Alliance for Clinical Trials in Oncology

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Alliance for Clinical Trials in Oncology
Interventions being studied
Biological: filgrastim; Drug: amifostine trihydrate; Drug: cisplatin; Drug: etoposide; Drug: paclitaxel; Drug: topotecan hydrochloride; Radiation: radiation therapy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Small cell lung cancer (SCLC)→
Treatment approach
Chemotherapy→Radiation therapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed small cell lung cancer
  • Limited disease confined to one hemithorax, the ipsilateral supraclavicular fossa, and encompassable within tolerable thoracic radiotherapy field
  • Minimal pleural effusions (i.e., blunting of the costophrenic angle on chest x-ray or a small effusion on CT scan) allowed
  • Measurable disease
  • At least one lesion accurately measured in at least 1 dimension with longest diameter at least 20 mm PATIENT CHARACTERISTICS: Age:
  • 18 and over Performance status:
  • ECOG 0-2 Life expectancy:
  • At least 12 weeks Hematopoietic:
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3 Hepatic:
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST no greater than 3 times ULN Renal:
  • Creatinine no greater than 1.5 times ULN Cardiovascular:
  • No New York Heart Association class III or IV heart disease Pulmonary:
  • FEV\_1 at least 40% of predicted AND at least 1 liter Other:
  • No uncontrolled infection
  • No other severe underlying diseases
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinomas (carcinoma in situ)
  • No grade 2 or greater peripheral neuropathy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No hypersensitivity to E.coli-derived proteins, filgrastim (G-CSF), or any excipients of G-CSF PRIOR CONCURRENT THERAPY: Biologic therapy
  • Not specified Chemotherapy
  • Not specified Endocrine therapy
  • Not specified Radiotherapy
  • No prior hemithorax radiotherapy Surgery
  • Not specified Other
  • No prior therapy for small cell lung cancer

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • CCOP - Mayo Clinic Scottsdale Oncology ProgramScottsdale, Arizona
  • Mayo Clinic - JacksonvilleJacksonville, Florida
  • Rush-Copley Cancer Care CenterAurora, Illinois
  • St. Joseph Medical CenterBloomington, Illinois
  • Graham HospitalCanton, Illinois
  • Memorial HospitalCarthage, Illinois
  • Eureka Community HospitalEureka, Illinois
  • Galesburg ClinicGalesburg, Illinois
  • Galesburg Cottage HospitalGalesburg, Illinois
  • InterCommunity Cancer Center of Western IllinoisGalesburg, Illinois
  • Mason District HospitalHavana, Illinois
  • Hopedale Medical ComplexHopedale, Illinois

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 6, 2016. Always confirm current availability with the study team.

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