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Completed

NCT Number: NCT01142102

Feasibility of Online Adaptive Radiotherapy for Muscle Invasive Bladder Cancer

The principal objective of the trial is to test the hypothesis that Online Adaptive Radiotherapy for Muscle Invasive Bladder Cancer is feasible across multiple Radiation Oncology departments.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Loading trial locations.

About this study

This is a single-arm multicentre feasibility trial in which the primary aim is to determine the compliance rate of patients to online adaptive radiotherapy for muscle invasive bladder cancer over multiple Australian and New Zealand centres. The compliance rate is defined as the proportion of patients successfully completing treatment without a major protocol deviation.

Subject to the accrual being at least 40 patients in the first 2 years, accrual will continue until a total of 50 patients have been accrued. If this accrual target is not met, then consideration will be given to stopping the trial early due to poor accrual. Each patient will be followed-up until 2 years after the last patient's date of accrual. Assessments for toxicity and recurrence or progression will take place at four weeks after completion of treatment, then three monthly from the end of treatment for the first 12 months and then 6 monthly thereafter.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years or older
  • Has provided written Informed Consent for participation in this trial
  • Histologically confirmed muscle invasive bladder cancer.
  • Transitional cell, squamous cell, adenocarcinoma or mixed histology. Stage T2-4 N0 M0.
  • An ECOG performance status score of 2 or less (see appendices).
  • Life expectancy greater than 6 months.
  • Considered suitable for radical radiotherapy.
  • Participants capable of childbearing are using adequate contraception.
  • Radiotherapy must be able to be commenced within 12 weeks of surgery.
  • Available for follow up.

Exclusion criteria

  • Women who are pregnant or lactating.
  • Previous pelvic radiotherapy
  • Previous cystectomy
  • A small contracted bladder
  • Unilateral or bilateral hip replacement
  • Small cell histology
  • Clinical or radiological evidence of nodal or distant metastases
  • Presence of indwelling urinary catheter

Treatment and study plan

radiation therapy

Radiation

A radical dose of radiotherapy to be delivered to the entire bladder volume: 64Gy in 32 fractions over 6 weeks and 2 treatment days.

  • Conventional plan is used to deliver treatment for fractions 1 to 7 using a standard planning approach and a CTV to PTV margin of 1.5cm.
  • Adaptive plan is used to deliver treatment for fractions 8 through 32 using the same standard techniques as for fractions 1 to 7 but using one of three specific CTV volumes,namely: small, average or large. In all these cases the CTV to PTV margin is 0.7cm. Image guidance using a treatment unit based verification CT unit (Cone Beam CT or CT on Rails)based on soft tissue delineation is used to position the treatment fields and select the plan to best cover the CTV.

Primary outcomes

  1. Compliance with Online Adaptive Radiation Therapy process

    Time frame: From the start date of radiotherapy to the last day of radiotherapy treatment (approxiamately 6 weeks and 2 days)

    A patient is considered to be compliant if that patient completes treatment without experiencing a major protocol deviation

Secondary outcomes

  1. Pattern of failure and competing risks analysis

    Time frame: From date of enrolment, every three months after RT untill 24 months, then 6 monthly until the end of the trial

    Patients will be assessed at baseline, weekly durning radiotherapy, 1 month post radiotherapy, then every three months until two years post radiotherapy.

  2. Disease Free survival

    Time frame: From date of enrolment, every three months after RT untill 24 months, then 6 monthly until the end of the trial

    Patients will be assessed at baseline, weekly durning radiotherapy, 1 month post radiotherapy, then every three months until two years post radiotherapy.

  3. Acute Toxicity of >/= grade 3 (NCI CTCAE version 4.0) of gastointestinal, diarrhoea, nausea, vomiting, colitis, proctitis, renal/genitourinary, cyctitis non-infective, haematuria, uinary frequency, urinary urgency and urinary retension.

    Time frame: From start date of radiotherapy and within 3 months of completion of radiation treatment

    Patients will be assesed at baseline, weekly durning radiotherapy, then at one month and three months post radiotherapy.

  4. Quality of Life

    Time frame: Within 2 weeks prior to commencement of treatment, during the last week of treatment, 1 and 18 months after the completion of treatment.

    Patients will be assessed at baseline, on the last day of radiotherapy, at one month post radiotherapy, then at 18 months follow up.

  5. Late normal tissue effects

    Time frame: Between 3 months and 3 years after the completion of radiation treatment

    Patients will be assessed at 3 monts post radiotherapy, then every 3 months until 2 years post radiotherapy.

  6. Time to Local Bladder Failure

    Time frame: From date of enrolment to date of local bladder failure

    Patients will be assessed at baseline, weekly durning radiotherapy, 1 month post radiotherapy, then every three months until two years post radiotherapy.

Sponsors and collaborators

Lead sponsor

Trans Tasman Radiation Oncology Group

Other

Registry information

Official study title

A Multicentre Feasibility Study of Online Adaptive Image Guided Radiotherapy for Muscle Invasive Bladder Cancer

Acronym: BOLART

Important dates

Study start
2010
Primary completion
2013
Study completion
2015
First posted
Jun 11, 2010
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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