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Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Screening - Prior an Concomitant Medication; Telephone Randomisation

- 18/04/21 - 1 modulo, 4 itemgroups, 13 elementi, 1 linguaggio
Itemgroups: Administrative, Prior and Concomitant Medication, Prior and Concomitant Medication , Telephone Randomisation
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Screening - Toxicities Related to Previous Radiotherapy for SCLC; 12-Lead Electrocardiogram; Diagnostic Studies for Tumor Assessment; Ongoing Medical Conditions Associated with SCLC; Significant Medical/Surgical History and Physical Examination

- 17/04/21 - 1 modulo, 9 itemgroups, 20 elementi, 1 linguaggio
Itemgroups: Administrative, Toxicities related to previous Radiotherapy for SCLC, Toxicities related to previous Radiotherapy for SCLC, 12-Lead Electrocardiogram, Diagnostic Studies for Tumor Assessment, Ongoing Medical Conditions Associated with SCLC, Ongoing Medical Conditions Associated with SCLC, Significant Medical/ Surgical History and Physical Examination, Significant Medical/ Surgical History and Physical Examination
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Cisplatin and Topotecan Recurrent or Persistent Carcinoma of the Cervix - 103369 - Pathology Report

- 31/12/19 - 1 modulo, 6 itemgroups, 20 elementi, 1 linguaggio
Itemgroups: Administrative data, Primary, Histology Type, Histologic Grade, Specimens, Secondary
Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer 

Cisplatin and Topotecan Recurrent or Persistent Carcinoma of the Cervix - 103369 - GOG Toxicity Case Summary

- 15/03/19 - 1 modulo, 12 itemgroups, 55 elementi, 2 lingue
Itemgroups: Administrative data, Demographics, Description, Protocol Treatment, Drugs and Doses for this Course, Cumulative Totals to Date, Serious Adverse Event, Pretreatment Counts for this Course, Nadir Counts, GOG #, Quality of Life Cover Sheet (Investigator's details), Time of Today's Assessment
Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer 

Cisplatin and Topotecan Recurrent or Persistent Carcinoma of the Cervix - 103369 - Treatment Completion Form

- 14/03/19 - 1 modulo, 10 itemgroups, 39 elementi, 1 linguaggio
Itemgroups: Administrative data, Treatment Completion, Tumor Measurements, Best Tumor Response, Follow-Up Form, Disease Follow-Up Status, Notice of New Primary, Long Term Adverse Events, Adverse Events details, Additional Cancer Therapy
Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer 

Cisplatin and Topotecan Recurrent or Persistent Carcinoma of the Cervix - 103369 - Common Toxicity Report

- 14/03/19 - 1 modulo, 2 itemgroups, 15 elementi, 1 linguaggio
Itemgroups: Administrative data, Common Toxicity Report
Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer 

Cisplatin and Topotecan Recurrent on Persistent Carcinoma of the Cervix - 103369 - Drug Dose Form

- 14/03/19 - 1 modulo, 6 itemgroups, 38 elementi, 1 linguaggio
Itemgroups: Administrative data, Investigational Product, Drug Dose, Tumor Measurements, Best Tumor Response, Pre-treatment Hematologies and Chemistries
Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer 

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