Clinical Trials Logo
  1. Home
  2. Bladder Neoplasms
  3. NCT00963404
  4. Details
NCT00963404 Clinical Trial

Image-Guided Tumorboost of Bladder Cancer

Bladder Neoplasms Clinical Trial

Official title:
Image-guided Tumorboost of Localized Unifocal Bladder Cancer: A Phase I/II Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00963404
Other study ID # CIRRO IP 070109 DaBlaCa-1
Secondary ID M-20080210
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date August 2009
Est. completion date January 2017

Study information
Verified date January 2018
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to increase the radiation dose (Boost) to the bladder tumor. The bladder cancer patients included in the study will undergo tumor demarcation. The bladder demarcations will then be the target for an image-guided boost delivered precisely to the expected tumor site.

Recruitment information / eligibility
Status Completed
Enrollment 19
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Muscle invasive bladder cancer (transitional carcinoma)

- Unifocal

- TNM stage T2a-4a, N0-1, M0

- unfit for radical cystectomy

Exclusion Criteria:

- Hyperthyroidism

- Multinodular goiter

- Pregnancy

- Breast feeding

- WHO preformance status more than 2

- Iodine allergy

- MRI or CT contrast media allergy

- Bi-lateral hip-prosthesis

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• Radiation boost
Radiation boost of the bladder-tumor: 10 Gy/5 fractions, 2 Gy per fraction.

Locations
Country Name City State
Denmark The department of Oncology, Aarhus University Hospital Aarhus
Denmark The department of Oncology, Rigshospitalet Copenhagen
Denmark The department of Oncology, Herlev University Hospital Herlev
Denmark The department of Oncology, Odense University Hospital Odense

Sponsors (2)
Lead Sponsor Collaborator
University of Aarhus Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Local tumor control One year
Secondary Acute and late adverse effects of the radiotherapy treatment 3 years
See also
  Status Clinical Trial Phase
Completed NCT00536588 - A Safety and Tolerability Study of SCH 721015 in Patients With Transitional Cell Carcinoma of the Bladder (Study P03816) Phase 1
Recruiting NCT00872495 - Evaluation of Non-Invasive Assays for the Detection of Urothelial Cancer
Terminated NCT02900248 - CureOne Registry: Advanced Malignancy or Myelodysplasia, Tested by Standard Sequencing and Treated by Physician Choice
Completed NCT00406068 - Mycobacterial Cell Wall-DNA Complex in Treatment of BCG-refractory Patients With Non-muscle Invasive Bladder Cancer Phase 2/Phase 3
Completed NCT00077688 - TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced Unresectable Transitional Cell Carcinoma of the Urothelium Phase 2
Completed NCT00462488 - Study of Vicinium for Treating Patients With Non-Invasive Urothelial Carcinoma In Situ Phase 2
Completed NCT00001381 - A Phase I Trial Using Suramin to Treat Superficial Transitional Cell Carcinoma of the Bladder Phase 1
Terminated NCT00050687 - Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Various Refractory Malignancies Phase 1/Phase 2
Completed NCT00343356 - Intravesical Epirubicin Plus BCG to Prevent the Recurrence of Transitional Cell Carcinoma of Bladder Phase 2
Completed NCT01090388 - Bladder Cancer Patient-Reported Outcomes N/A
Completed NCT00141531 - Phase II Trial of EOquin in High-risk Superficial Bladder Cancer Phase 2
Completed NCT00315237 - Phase III Trial of Vinflunine Plus Best Supportive Care vs. Best Supportive Care in Patients With Transitional Cell Carcinoma (TCC) of the Urothelial Tract Phase 3
Completed NCT00491114 - Intravesical Chemotherapy Treatment of Superficial Bladder Cancer Phase 2
Completed NCT00393809 - Safety and Proof of Concept Study of Intravesical DTA-H19 in Patients With Superficial Bladder Cancer Phase 1/Phase 2
Completed NCT00101608 - Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium Phase 2
Terminated NCT00191477 - Instillation of Gemcitabine in Patients With Superficial Bladder Cancer Phase 3
Recruiting NCT05072600 - Pembrolizumab Monotherapy Following Tri-modality Treatment for Selected Patients With Muscle-invasive Bladder Cancer Phase 2
Active, not recruiting NCT00109655 - Dose-Escalation Study of CG0070 for Bladder Cancer After BCG (Bacillus Calmette-Guerin) Failure Phase 1
Completed NCT00188695 - Combidex USPIO - Ultra-small Superparamagnetic Iron Oxide Phase 1/Phase 2
Active, not recruiting NCT00871754 - Molecular Analysis Of Bladder Cancer

External Links