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Eligibility DRKS00003645 NCT00349076 Rectal Neoplasms - Eligibility

- 20/09/2021 - 1 Formulaire, 2 Groupes Item, 21 Eléments de données, 2 Langues
Groupes Item: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT00349076

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - CRF Tracking/Review Forms

- 22/08/2019 - 1 Formulaire, 2 Groupes Item, 13 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Clinical Trial Regulatory Tracking Document
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Topotecan Post-Study Minimal Follow-up Report

- 21/08/2019 - 1 Formulaire, 5 Groupes Item, 19 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Follow-Up Report, Month, Patient Outcome, Cessation of life, Investigator Signature
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Patient Assignment Sheet

- 21/08/2019 - 1 Formulaire, 2 Groupes Item, 9 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Patients, Assignment
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Patient Log

- 21/08/2019 - 1 Formulaire, 2 Groupes Item, 5 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Patients, Exclusion
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Laboratory Reference Ranges

- 21/08/2019 - 1 Formulaire, 2 Groupes Item, 6 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Reference lab test reference range
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Form D

- 21/08/2019 - 1 Formulaire, 2 Groupes Item, 10 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Cessation of life
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Serious Adverse Experiences (SAE)

- 20/08/2019 - 1 Formulaire, 6 Groupes Item, 31 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Serious Adverse Event, Serious Adverse Event. Laboratory test finding, Serious Adverse Event, Comment, Serious Adverse Event, Randomization, Serious Adverse Event, Investigator Signature
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Response Assessment

- 20/08/2019 - 1 Formulaire, 4 Groupes Item, 12 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, TNM clinical staging, Rectal Carcinoma, Pathological staging, Rectal Carcinoma, Sphincter, Preservation technique
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Study Conclusion

- 20/08/2019 - 1 Formulaire, 3 Groupes Item, 10 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Clinical Trials, Conclusion, Investigator Signature
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Adverse Experiences (Non-serious)

- 20/08/2019 - 1 Formulaire, 2 Groupes Item, 15 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Non-Serious Adverse Event
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Post RT/Prior to Surgery

- 19/08/2019 - 1 Formulaire, 4 Groupes Item, 14 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Serious Adverse Event, 12 lead ECG, Experimental drug, Compliance behavior
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

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