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Transitional Cell Carcinoma of Urinary BladderPhase 3NCT00330499

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

A Phase 3 study testing Cisplatin and External beam radiation treatment in people with Transitional Cell Carcinoma of Urinary Bladder, run by Trans Tasman Radiation Oncology Group at 22 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cisplatin and External beam radiation treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
22 sitesin 2 countries
Study dates
Oct 2002to Feb 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • partial cystectomy;
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  • endoscopic resection of bladder tumour/s;
  • intravesical chemotherapy; or
  • 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.

Who cannot join

  • 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.
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  • 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:
  • non-melanoma skin cancer, and/or
  • (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

Trial locations and contacts

22 sites in 2 countries.

22 sites in 2 countries

Australia17 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Mater Centre - South Brisbane

    Brisbane, Queensland, 4120

  • Townsville Hospital

    Douglas, Queensland, 4814

  • Peter MacCallum Cancer Centre

    East Melbourne, Victoria, 3002

  • Andrew Love Cancer Care Centre, Geelong Hospital

    Geelong, Victoria, 3220

  • Royal Brisbane Hospital

    Herston, Queensland, 4029

  • Launceston General Hospital

    Launceston, Tasmania, 7250

  • Liverpool Hospital

    Liverpool, New South Wales, 1871

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Calvary Mater Newcastle

    Newcastle, New South Wales, 2298

  • Nepean Cancer Care Centre

    Penrith, New South Wales, 2751

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Alfred Hospital

    Prahran, Victoria, 3181

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • East Coast Cancer Centre

    Tugun, Queensland, 4224

  • Westmead Hospital

    Wentworthville, New South Wales, 2145

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

New Zealand5 sites

  • Auckland Hospital

    Auckland, 1001

  • Christchurch Hospital

    Christchurch, 4710

  • Dunedin Hospital

    Dunedin

  • Palmerston North Hospital

    Palmerston North

  • Wellington Hospital

    Wellington, 7902

Other trials in New Zealand

About this study

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

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.

Read the 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).

Being tested
Cisplatin, External beam radiation treatment
Keywords
Locally invasive, Bladder cancer, Chemoradiotherapy, Efficacy, Organ conservation
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CisplatinDrug

    Also called Cisplatuin Ebewe, Cisplatin Injection

    Weekly Cisplatin 35mg/m2 x 6 doses, IV administration

  • External beam radiation treatmentRadiation

    Also called Radiation

    64Gy reference dose in 32 fractions over 6.5 weeks

Study groups in NCT00330499
Study groupRoleWhat they receive
AExperimentalSynchronous chemo / radiation therapy
Receives: Drug: Cisplatin; Radiation: External beam radiation treatment
BActive comparatorRadiation Alone
Receives: Radiation: External beam radiation treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Invasive local failure at 3 years

    Measured: 3 years

Secondary outcomes (7)

  1. Complete response (CR) rate at 3 months from randomisation

    Measured: 3 months

  2. Disease-free survival

    Measured: Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)

  3. Overall survival

    Measured: Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)

  4. Cystectomy-free survival

    Measured: Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)

  5. Acute and late toxicity

    Measured: Interim analyses will be performed on an annual basis.

  6. Pattern of failure (local, regional, distant)

    Measured: Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)

  7. Quality of life measures

    Measured: Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2006 (estimated)
  2. Study startOct 2002
  3. Primary completionFeb 2010
  4. Study completionFeb 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00330499
Sponsor's protocol ID
TROG 02.03
Other IDs
NHMRC 243100
Status last verified
Jul 2017
First submitted
25 May 2006
Last updated
12 Jul 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cisplatin and External beam radiation treatment in people with Transitional Cell Carcinoma of Urinary Bladder, run by Trans Tasman Radiation Oncology Group at 22 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Invasive local failure at 3 years (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00330499.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017.

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