Radiotherapy with weekly gemcitabine (GEM)

Phase 2

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Bladder Cancer; Disease: Bladder (advanced); Cancer; Bladder cancer

• Registration Number: ISRCTN64153246
• Lead Sponsor: Christie Hospital NHS Foundation Trust (UK)

Brief Summary

2011 results in https://www.ncbi.nlm.nih.gov/pubmed/21205754

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2007-08-07
• Study Start: 2010-07-30
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1. Histologically confirmed T2-3 N0M0 transitional cell carcinoma (TCC) of the bladder*
2. Life expectancy greater than 3 months
3. World Health Organization (WHO) performance status 0 ? 2
4. Patients opting for bladder preservation who are able and motivated to comply with follow up
5. Maximal achievable transurethral resection of bladder tumour (TURBT)
6. Serum creatinine less than 1.5 x upper limit of normal (ULN)
7. Haemoglobin (Hb) greater than 10 g/dl, platelets greater than 100,000/mm^3, white cell count (WCC) greater than 2000/mm^3
8. Aged greater than 18 years
9. Provided informed consent

*Patients with TCC in whom biopsy fails to demonstrate histological evidence of muscle invasion but where magnetic resonance (MR) demonstrates unequivocal evidence of deep muscle invasion can be accepted for trial entry

Exclusion Criteria

1. Residual tumour with any unidimensional measurement greater than or equal to 7 cm following TURBT
2. Poor bladder function:
2.1. Any WHO bladder symptom score equalling 3 or greater than or equal to two bladder symptom scores equalling 2
2.2. Documented bladder capacity less than or equal to 200 ml
3. Abnormal liver function tests (LFT) (bilirubin greater than 1.3 x ULN, alkaline phosphatase greater than 5 x ULN, transaminases greater than 5 x ULN)
4. Previous radiotherapy to pelvis
5. More than one instillation of intravesical cytotoxic chemotherapy or immunotherapy
6. Any previous systemic chemotherapy
7. Radiotherapy planning target volume (PTV) greater than 1000cm^3
8. Any prior malignancy (excluding basal cell carcinoma [BCC])
9. Pre-existing medical conditions that preclude this treatment
10. Pregnant or breast-feeding
11. Not able to use appropriate and/or adequate contraception during and for 3 months after the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified