Feasibility of Online Adaptive Radiotherapy for Muscle Invasive Bladder Cancer (BOLART)

Trans Tasman Radiation Oncology Group

Status: Completed

Conditions: Bladder Cancer

Treatments: Radiation: Radiation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01142102

TROG 10.01

ACTRN12610000711011 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Arm 1

Experimental group

Description:

Radiation Therapy

Treatment:

Radiation: Radiation Therapy