ISRCTN64153246
Completed
Phase 2
Phase II study of radiotherapy with concurrent weekly gemcitabine in muscle-invasive bladder cancer
Christie Hospital NHS Foundation Trust (UK)0 sites50 target enrollmentJuly 30, 2010
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Christie Hospital NHS Foundation Trust (UK)
- Enrollment
- 50
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
2011 results in https://www.ncbi.nlm.nih.gov/pubmed/21205754
Investigators
Eligibility Criteria
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])
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 2
Phase II Study of Concurrent Radiotherapy With Envafolimab and Capecitabine in LAPCPancreatic CancerRadiotherapyEnvafolimabCapecitabineNCT06202014Cancer Institute and Hospital, Chinese Academy of Medical Sciences43
Unknown
Phase 2
CCRT With Itraconazole in Locally Advanced Squamous Esophageal CancerEsophageal NeoplasmEsophageal DiseasesEsophageal Squamous Cell CarcinomaNCT04481100Hangzhou Cancer Hospital38
Recruiting
N/A
Bladder preservation with Panitumumab and radiotherapy.Bladder carinoma, preservation, radiotherapy, PanitumumabNL-OMON28908KI-Av31
Not Yet Recruiting
Phase 2
Phase II Study of Different Doses of Radiotherapy Combined With Sintilimab in the Treatment of Locally Advanced Esophageal Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaNCT06468644Fujian Cancer Hospital60
Unknown
Phase 1
Neoadjuvant Chemoradiation With 5-FU(or Capecitabine) and Oxaliplatin Combined With Hyperthermia in Rectal CancerRectal CancerNCT01716949University of Erlangen-Nürnberg Medical School59