Daily Online Adaptive Short-Course Radiation Therapy and Concurrent Chemotherapy for Muscle-Invasive Bladder Cancer (ARTIA-Bladder)

  • End date
    Feb 1, 2027
  • participants needed
  • sponsor
    Varian, a Siemens Healthineers Company
Updated on 8 April 2023


This trial is a single-arm, prospective, multi-center clinical trial designed to demonstrate that adaptive radiotherapy for muscle-invasive bladder cancer will translate into a decreased rate of acute (assessed weekly during chemo-radiotherapy) grade 3 or greater gastrointestinal/genitourinary toxicity compared with the historically reported rate for non-adaptive radiation therapy. The Common Terminology Criteria for Adverse Events (CTCAE) version 5 assessment tool will be utilized.

Condition Muscle Invasive Bladder Urothelial Carcinoma
Treatment Daily Adaptive External Beam Radiation Therapy
Clinical Study IdentifierNCT05700227
SponsorVarian, a Siemens Healthineers Company
Last Modified on8 April 2023


Yes No Not Sure

Inclusion Criteria

Age ≥ 18 years
Patients must have histologically proven cT2-T4aN0M0 (AJCC v8) urothelial carcinoma of the bladder with an intact bladder. Mixed urothelial histology is permitted as long as there is some urothelial histology component and no small cell component present
Patients must have undergone an attempt at maximal transurethral resection of bladder tumor (TURBT) within 70 days prior to enrollment
A negative pelvic nodal status is to be confirmed by one or more of the following studies/procedures: PET/CT scan, CT scan, MRI scan, fine needle biopsy, extra peritoneal biopsy, or laparoscopic biopsy, per institutional standard of care
Patients must be planning to undergo concurrent pelvic radiation and chemotherapy with curative intent
ECOG performance status ≤2 (Karnofsky ≥60%)
Ability to complete required patient questionnaires
Ability to understand and the willingness to sign a written informed consent document
Patients must have normal organ and marrow function as defined below, obtained within 28 days prior to enrollment
absolute neutrophil count ≥1,500/mcL
platelets ≥100,000/mcL
hemoglobin ≥9 g/dL (can be transfused with red blood cells pre-study)
total bilirubin ≤1.5 × institutional upper limit of normal (ULN) unless the patient has Gilbert's syndrome who must have total bilirubin <3.0 mg/dL
alkaline phosphatase ≤2.5 × ULN
creatinine clearance ≥30 ml/min. We recommend avoiding cisplatin for patients with creatinine clearance <50 ml/min
For the purpose of estimating the creatinine clearance, this formula may be
Estimated creatinine clearance=((140-age)×wt (kg) ×0.85 (if female))/(72 x creatinine
(mg/dl) )
Female patients of childbearing potential (defined as having a menses at any time in
the preceding 12 months) must have a negative serum pregnancy test prior to
enrollment. Patients must not be pregnant or nursing because of the potential risk of
injury to the fetus/child

Exclusion Criteria

Grade ≥ 2 CTCAE GI or grade ≥ 3 GU symptoms/conditions at baseline (including ongoing
refractory gross hematuria post TURBT)
Patients with clinically involved nodes (nodes consistent morphologically with
malignancy and which are greater than 1 cm on short axis on CT or MRI)
Patients with cT4b disease. Patients with T4 disease after 8 subjects with T4 disease
have been enrolled
Bilateral hydronephrosis or diffuse carcinoma in situ based on cystoscopy or biopsy
Unilateral hydronephrosis is allowed provided the patient's kidney function meets the
trial criteria. Patients should be evaluated for consideration of stenting or
nephrostomy tubes for moderate-to-severe unilateral hydronephrosis prior to initiation
of chemo-radiotherapy
Prior radiation therapy to the pelvis or abdominal cavity, prior systemic
chemotherapy/systemic therapy for bladder cancer. Prior intravesical therapy (BCG
interferon, intravesical chemotherapy) is allowed provided the time interval from
completion of intravesical therapy is at least 3 months
Prior cystectomy or partial cystectomy
Prior malignancy (except for non-melanoma skin cancer) unless disease-free for at
least 2 years. Prior non-muscle invasive bladder cancer is allowed. Patients must not
have a history of urothelial carcinoma or variant histology at any site outside of the
urinary bladder within the previous 24 months except Ta/T1/carcinoma in situ of the
upper urinary tract (including renal pelvis and ureter) provided the patient has
undergone complete nephroureterectomy and still meets trial eligibility for creatinine
clearance. Patients with localized prostate cancer who are being followed on an active
surveillance program are also eligible
Prior allogeneic bone marrow transplantation or prior solid organ transplantation
Prior systemic anticancer therapy due to a diagnosis of cancer (e.g., chemotherapy
targeted therapy, immunotherapy) within 3 years prior to entering the study or
induction chemotherapy prior to the start of concurrent chemo-radiotherapy
Serious medical comorbidities precluding RT and/or chemotherapy (e.g., active
uncontrolled infection )
Patients with a history of inflammatory bowel disease, including ulcerative colitis
and Crohn's Disease
Patients with scleroderma. Patients who are symptomatic from other auto-immune
diseases or patients on biologic therapies for auto-immune diseases are also excluded
Patients with active tuberculosis (TB)
Patients who are pregnant or actively breastfeeding and who do not agree to
discontinue breastfeeding before the initiation of radiation treatment planning or
bladder cancer therapy
Women of childbearing potential and men who do not agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry, for
the duration of protocol treatment, and for 5 months after the last study treatment
Patients with a prior known history or current diagnosis of bowel fistula
Patients who undergo a pelvic or para-aortic lymph node dissection prior to planned
chemoradiation therapy
Patients with known active infection of HIV
Patients with bilateral hip prosthetics. Select patients with unilateral hip
prosthetics are eligible provided that a diagnostic CT scan permits good visualization
of the entire bladder and adjacent bowel. Patients with poor visualization of the
bladder/bowel on diagnostic CT scan prior to simulation should not be enrolled
Patients with poorly visualized bladder and bowel on diagnostic CT [either due to body
habitus or artifact (motion, artifact, etc.)] are excluded
Patients who in the opinion of the investigator are not able to spend 30 minutes lying
on the radiation therapy treatment couch due to significant urinary frequency/urgency
or other co-morbidities
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