Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00622349
NCT00622349
Completed
Phase 3

A Phase III Randomised Study Comparing Three Combination Chemotherapy Regimens in Patients With Non Pre-treated Advanced Non-small Cell Lung Cancer

European Lung Cancer Working Party4 sites in 4 countries707 target enrollmentFebruary 2004
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsCarcinoma, Non-Small-Cell Lung
InterventionsCisplatin, Ifosfamide, GemcitabineIfosfamide, GemcitabineCisplatin, docetaxel
DrugsCisplatin, Ifosfamide, GemcitabineIfosfamide, GemcitabineCisplatin, docetaxel

Overview

Phase
Phase 3
Intervention
Cisplatin, Ifosfamide, Gemcitabine
Conditions
Carcinoma, Non-Small-Cell Lung
Sponsor
European Lung Cancer Working Party
Enrollment
707
Locations
4
Primary Endpoint
Survival
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to determine if cisplatin-based chemotherapy, cisplatin-gemcitabine-ifosfamide or cisplatin-docetaxel, will improve survival in comparison to the combination gemcitabine-ifosfamide in patients with advanced NSCLC

Registry
clinicaltrials.gov
Start Date
February 2004
End Date
December 2009
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Histological or cytological diagnosis of non-small cell lung cancer
  • •Advanced (unresectable or functionally inoperable) stage III or stage IV disease
  • •Availability for participating in the detailed follow-up of the protocol
  • •Presence of an evaluable or measurable lesion
  • •Informed consent

Exclusion Criteria

  • •Prior treatment with chemotherapy
  • •Operable patient with resectable tumour
  • •Performance status \< 60 on the Karnofsky scale
  • •A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval)
  • •Polynuclear cells \< 2,000/mm³
  • •Platelet cells \< 100,000/mm³
  • •Serum bilirubin \>1.5 mg/100 ml
  • •Serum creatinine \> 1.5 mg/100 ml and/or creatinine clearance \< 60 ml/min
  • •Perception hypoacousia
  • •Peripheral neuropathy

Arms & Interventions

A

Intervention: Cisplatin, Ifosfamide, Gemcitabine

B

Intervention: Ifosfamide, Gemcitabine

C

Intervention: Cisplatin, docetaxel

Outcomes

Primary Outcomes

Survival

Time Frame: Survival will be dated from the first day of registration until death or last follow up

Secondary Outcomes

  • Response rate(Every 3 courses of chemotherapy)
  • Toxicity(After each course of chemotherapy)
  • Activity of second-line chemotherapy(Every 3 courses of chemotherapy)

Study Sites (4)

Loading locations...

Similar Trials

Unknown
Phase 3
Trial Comparing Cisplatin With or Without Gemcitabine in Patients With Carcinoma of Unknown PrimaryCarcinoma
NCT00126269Gustave Roussy, Cancer Campus, Grand Paris192
Completed
Phase 3
Gemcitabine Hydrochloride and Cisplatin With or Without Nab-Paclitaxel in Treating Patients With Newly Diagnosed Advanced Biliary Tract CancersStage III Distal Bile Duct Cancer AJCC v8Stage III Gallbladder Cancer AJCC v8Stage III Intrahepatic Cholangiocarcinoma AJCC v8Stage IIIA Distal Bile Duct Cancer AJCC v8Stage IIIA Gallbladder Cancer AJCC v8Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8Stage IIIB Distal Bile Duct Cancer AJCC v8Stage IIIB Gallbladder Cancer AJCC v8Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8Stage IV Distal Bile Duct Cancer AJCC v8Stage IV Gallbladder Cancer AJCC v8Stage IV Intrahepatic Cholangiocarcinoma AJCC v8Stage IVA Gallbladder Cancer AJCC v8Stage IVB Gallbladder Cancer AJCC v8Unresectable Extrahepatic Bile Duct CarcinomaUnresectable Gallbladder CarcinomaUnresectable Intrahepatic Cholangiocarcinoma
NCT03768414SWOG Cancer Research Network452
Completed
Phase 2
Gemcitabine, Cisplatin, and Sunitinib (GC-S) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder CancerBladder CancerUrinary Bladder
NCT00847015Memorial Sloan Kettering Cancer Center18
Withdrawn
Phase 2
Cisplatin/Paclitaxel/Gemcitabine +/- Avastin in Patients With Unknown Primary TumorUnknown Primary Tumors
NCT00458315Rigshospitalet, Denmark
Completed
Phase 3
Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract CancerAdvanced Urothelial CarcinomaMetastatic Bladder Urothelial CarcinomaMetastatic Prostate CarcinomaMetastatic Renal Pelvis Urothelial CarcinomaMetastatic Ureter Urothelial CarcinomaMetastatic Urethral Urothelial CarcinomaMetastatic Urothelial CarcinomaStage IV Bladder Urothelial Carcinoma AJCC v7Stage IV Prostate Cancer AJCC v7Stage IV Renal Pelvis Cancer AJCC v7Stage IV Ureter Cancer AJCC v7Stage IV Urethral Cancer AJCC v7Unresectable Urothelial Carcinoma
NCT00942331National Cancer Institute (NCI)506