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Trial: NCT00003202 [RDF]

Label NCT00003202
Slug nct00003202
Trialid NCT00003202
Lookup name NCT00003202
Provenance http://clinicaltrials.gov/show/NCT00003202?displayxml=true
Lastchanged date
Firstreceived results date
Firstreceived date
Id info nct id NCT00003202
Overall status Completed
Id info secondary id CCCWFU-62197
Biospec retention
Required header link text Link to the current ClinicalTrials.gov record.
Enrollment 40
Number of arms
Is section 801
Is fda regulated
Brief title Gemcitabine Plus Radiation Therapy or Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer
Acronym
Official title Alternating Phase I/II Trials of Twice-Weekly Infusion Gemcitabine (2'2'-Difluoro-2'-Deoxycytidine) and Concurrent Thoracic Radiation Alone - Or Following 2 Cycles of Cisplatin/Gemcitabine Induction Chemotherapy for the Treatment of Stage IIIA/IIIB Non Small Cell Lung Cancer (NSCLC)
Study type Interventional
Id info nct alias
Completion date July 2006
Verification date August 2018
Why stopped
Id info org study id CDR0000066052
Required header url https://clinicaltrials.gov/show/NCT00003202
Study design
Source Wake Forest University Health Sciences
Primary completion date April 2002
Brief summary
Number of groups
Required header download date ClinicalTrials.gov processed this data on August 24, 2018
Phase Phase 1/Phase 2
Start date January 1998
Has expanded access No
Biospec descr
Detailed description OBJECTIVES: - Determine the maximum tolerated dose of twice-weekly gemcitabine when delivered concurrently with thoracic radiotherapy alone or following 2 cycles of induction chemotherapy in patients with Stage IIIA or IIIB non-small cell lung cancer. - Assess the toxicity of concurrent thoracic radiation and gemcitabine in these patients. - Determine the effectiveness of concurrent radiation and gemcitabine by determining the complete response rate, partial response rate, time to recurrence, pattern of recurrence, and overall survival in a cohort of these patients. OUTLINE: This is an alternating two arm, dose escalation, multicenter study. Arm I: Patients receive twice-weekly gemcitabine as a 30 minute infusion. Concurrent radiation therapy is administered 5 days a week for 6 weeks. Arm II: Patients receive 2 cycles of induction chemotherapy consisting of gemcitabine as a 30 minute infusion on day 1 and 8 and cisplatin IV over 1 hour on day 1. Each cycle is 21 days. Patients then receive gemcitabine and radiation therapy as in arm I. Cohorts of 3 patients are enrolled into each treatment arm at each dose level of gemcitabine. Toxicity for each arm is assessed independently. Once dose limiting toxicity (DLT) is observed at any dose level, 3 more patients are enrolled at the same dose level. The maximum tolerated dose (MTD) is defined as the dose at which no more than 1 of 6 patients experiences grade 4 toxicity, or no more than 4 of 6 patients experience grade 3 or worse toxicity (DLT). After the MTD is determined for each treatment arm, additional patients are treated at that dose level for the phase II portion of the study. Patients are followed every 3 months for 2 years, then every 4 months for the next 2 years, and then every 6 months thereafter. PROJECTED ACCRUAL: There will be approximately 24-48 patients accrued into this study within 1-2 years.
Condition browse None
Intervention browse None
Responsible party None
Overall contact None
Overall contact backup None
Sponsor group None
Oversight info None
Eligibility None
Keywords adenocarcinoma of the lung, adenosquamous cell lung cancer, large cell lung cancer, squamous cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
Conditions Lung Cancer
Locations f3a33b41a7dc23914ca8433218ff29d3
Links None
Results references None
Arm groups None
Location countries United States
Interventions gemcitabine hydrochloride (Intervention), radiation therapy (Intervention), cisplatin (Intervention)
Secondary outcomes c915463192805ab8e326444c0b26b7a2
References None
Primary outcomes 4af9b388121bbef9185fb0d4e3e779f7
Removed countries None
Overall officials None