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Efficacy Study of Adding Chemotherapy to Radiotherapy for Treating Bladder Cancer.

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ClinicalTrials.gov Identifier: NCT00330499
Recruitment Status : Completed
First Posted : May 26, 2006
Last Update Posted : July 12, 2017
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Trans-Tasman Radiation Oncology Group (TROG)

Brief Summary:
The purpose of this study is to define the optimal management of localised transitional cell carcinoma (TCC) of the urinary bladder. The main objective is to evaluate whether chemoradiation is superior to radiotherapy alone.

Condition or disease Intervention/treatment Phase
Transitional Cell Carcinoma of Urinary Bladder Drug: Cisplatin Radiation: External beam radiation treatment Phase 3

Detailed Description:

Whilst concurrent chemo-radiation is increasingly being looked upon as the treatment of choice for patients referred for bladder preservation, the study by the NCI of Canada (Coppin CM, Gospodarowicz MK et al.Improved Local Control of Invasive Bladder Cancer by Concurrent Cisplatin and Pre-operative or Definitive Radiation.J. of Clinical Oncol. 14(11): 2901-2907, 1996) is the only randomised trial to show some superiority of concurrent Cisplatin and radiation treatment over radiation alone in increasing pelvic tumour control. There was no impact on overall survival. However, this study had relatively small subject numbers and included two distinct treatment options. In one group the patients were treated with a bladder sparing approach and in the other by pre-operative therapy and cystectomy with the type of definitive treatment being decided upon by both the treating Specialist and patient. At 5 years the pelvic failure rates in the radiation alone and chemo-radiation arms were 59% and 40% respectively. With half of the patients in each group having had planned cystectomy as part of their treatment regimen, the above rates of local relapse (especially in the chemo-radiation arm) are disappointing.

Given the concerns with the above study, and the continuing paucity of randomised phase III studies comparing chemo-radiation with radiation alone, there lies an opportunity for Australasian centres to take up the challenge. For this study, the proposed schedule for the chemo-radiation arm is to be the same as that being investigated in our previous phase II study (six weekly doses of Cisplatin plus radiation to a dose of 64Gy in 32 fractions over 6.5 weeks). This will be compared with radical radiation alone (64Gy in 32 fractions over 6.5 weeks).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Trial of Radical Chemo/Radiotherapy vs Radiotherapy Alone in the Definitive Management of Localised Muscle Invasive TCC of the Urinary Bladder
Study Start Date : October 2002
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
Drug Information available for: Cisplatin

Arm Intervention/treatment
Experimental: A
Synchronous chemo / radiation therapy
Drug: Cisplatin
Weekly Cisplatin 35mg/m2 x 6 doses, IV administration
Other Name: Cisplatuin Ebewe, Cisplatin Injection

Radiation: External beam radiation treatment
64Gy reference dose in 32 fractions over 6.5 weeks
Other Name: Radiation

Active Comparator: B
Radiation Alone
Radiation: External beam radiation treatment
64Gy reference dose in 32 fractions over 6.5 weeks
Other Name: Radiation




Primary Outcome Measures :
  1. Invasive local failure at 3 years [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Complete response (CR) rate at 3 months from randomisation [ Time Frame: 3 months ]
  2. Disease-free survival [ Time Frame: Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial) ]
  3. Overall survival [ Time Frame: Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial) ]
  4. Cystectomy-free survival [ Time Frame: Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial) ]
  5. Acute and late toxicity [ Time Frame: Interim analyses will be performed on an annual basis. ]
  6. Pattern of failure (local, regional, distant) [ Time Frame: Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial) ]
  7. Quality of life measures [ Time Frame: Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven TCC of the urinary bladder. Mixed tumours comprising predominantly TCC and elements of squamous or adenomatous metaplasia or carcinoma are also eligible.
  • Clinically and radiologically localised T2, T3 or T4a non-bulky disease (<= 7cm in maximum dimension), N0, M0.

If radiological evaluation of a lymph node is interpreted as "positive" this must be evaluated further by either lymph node sampling or percutaneous needle biopsy. Patients with histologically confirmed lymph node metastases will not be eligible.

  • Maximal TUR.

N.B. Previous:

  1. partial cystectomy;
  2. endoscopic resection of bladder tumour/s;
  3. intravesical chemotherapy; or
  4. intravesical BCG

does not exclude the patient from being eligible. However, the patient should have an adequate functioning bladder (this should be clarified with the referring Urologist and if need be voiding volumes should be measured).

  • Creatinine clearance >= 50ml/minute by calculation or measurement.
  • A white blood cell count >= 3.5 x 10^9/L with an absolute neutrophil count >= 1.5 x 10^9/L and a platelet count >= 100 x 10^9/L.
  • ECOG status of 0, 1 or 2.
  • No age limit applies provided the patient is mentally, physically and geographically capable of undergoing treatment and follow-up.
  • No significant intercurrent morbidity.

Exclusion Criteria:

  • Pure squamous carcinomas or adenocarcinomas.
  • Extensive or multifocal CIS change in the bladder.
  • T3 or T4a tumours unsuitable for curative treatment (i.e. > 7cm in any dimension), T4b, node positive and metastatic disease.
  • Presence of ureteric obstruction due to tumour infiltration at the UO not amenable to stenting.
  • Previous radiation treatment to the pelvis.
  • Previous significant pelvic surgery.
  • Significant bowel or gynaecological inflammatory disease.
  • Creatinine clearance < 50ml/minute by calculation or measurement. A white blood cell count < 3.5 x 10^9/L with an absolute neutrophil count < 1.5 x 10^9L and/or a platelet count < 100 x 10^9/L.
  • Other considerations making patient unfit for Cisplatin therapy.
  • Prior or concurrent malignancy of any other site unless disease-free for greater than 5 years, except for:

    1. non-melanoma skin cancer, and/or
    2. (a) Stage T1 well differentiated prostatic carcinoma in men, and In situ carcinoma of the cervix in women.
  • Bladder tumour - biopsy only. These patients must be referred back for more adequate resections or else should not be included

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330499


Locations
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Australia, New South Wales
Liverpool Hospital
Liverpool, New South Wales, Australia, 1871
Calvary Mater Newcastle
Newcastle, New South Wales, Australia, 2298
Nepean Cancer Care Centre
Penrith, New South Wales, Australia, 2751
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Westmead Hospital
Wentworthville, New South Wales, Australia, 2145
Australia, Queensland
Mater Centre - South Brisbane
Brisbane, Queensland, Australia, 4120
Townsville Hospital
Douglas, Queensland, Australia, 4814
Royal Brisbane Hospital
Herston, Queensland, Australia, 4029
East Coast Cancer Centre
Tugun, Queensland, Australia, 4224
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Tasmania
Launceston General Hospital
Launceston, Tasmania, Australia, 7250
Australia, Victoria
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
Andrew Love Cancer Care Centre, Geelong Hospital
Geelong, Victoria, Australia, 3220
Alfred Hospital
Prahran, Victoria, Australia, 3181
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
New Zealand
Auckland Hospital
Auckland, New Zealand, 1001
Christchurch Hospital
Christchurch, New Zealand, 4710
Dunedin Hospital
Dunedin, New Zealand
Palmerston North Hospital
Palmerston North, New Zealand
Wellington Hospital
Wellington, New Zealand, 7902
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
National Health and Medical Research Council, Australia
Investigators
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Study Chair: Kumar Gogna Mater Centre - South Brisbane

Additional Information:
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Responsible Party: Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier: NCT00330499     History of Changes
Other Study ID Numbers: TROG 02.03
NHMRC 243100
First Posted: May 26, 2006    Key Record Dates
Last Update Posted: July 12, 2017
Last Verified: July 2017
Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
Locally invasive
Bladder cancer
Chemoradiotherapy
Efficacy
Organ conservation
Additional relevant MeSH terms:
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Carcinoma, Transitional Cell
Urinary Bladder Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Cisplatin
Antineoplastic Agents