Surgery With or Without Postoperative Intensity Modulated Radiation Therapy in Treating Patients With Urothelial Bladder Cancer


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Trial ID: NCT02316548


This randomized phase II trial studies the side effects and how well postoperative intensity modulated radiotherapy works after surgery in treating patients with urothelial bladder cancer. Radiation therapy uses high energy x-rays to kill tumor cells left behind in the pelvis after surgery. It is not yet known whether surgery followed by radiotherapy is more effective than surgery alone in treating patients with urothelial bladder cancer.

Official Title

Randomized Phase II Trial of Postoperative Adjuvant IMRT Following Cystectomy for pT3/T4 Urothelial Bladder Cancer

Stanford Investigator(s)

Mark Buyyounouski, MD, MS, FASTRO
Mark Buyyounouski, MD, MS, FASTRO

Professor of Radiation Oncology (Radiation Therapy)


Inclusion Criteria (A patient cannot be considered eligible for this study unless ALL of
the following conditions are met.):

   - Initial histological diagnosis of muscle invasive urothelial carcinoma

   - Patients must have undergone a radical cystectomy (reconstructed urinary diversion may
   be non-continent diversions (eg, ileal conduits) or continent non-orthotopic
   catheterizable diversions (eg, Indiana pouch) or continent orthotopic diversions (eg,
   Studer pouch or neobladder)for urothelial bladder carcinoma within 105 days prior to
   registration. Final cystectomy pathology must be either pure urothelial carcinoma or
   dominant urothelial carcinoma with admixture of other histologies excluding small cell

      - Neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy for the
      bladder cancer is permitted; however, all patients, even those who will receive
      adjuvant chemotherapy, must be registered within 105 days after completing
      cystectomy regardless of whether adjuvant chemotherapy has started. Patients who
      will be receiving adjuvant (postoperative) chemotherapy will be randomized within
      28 days of completing that chemotherapy.

   - Patients with the following pTNM stages per the American Joint Committee on Cancer
   (AJCC) 7th ed. are eligible:

      - pT3apN0; pN1; pN2 provided less than 10 nodes dissected and/or positive surgical

      - pT3bpN0; pN1; pN2

      - pT4apN0; pN1; pN2

      - pT4bpN0; pN1; pN2

   - Appropriate stage for study entry based on the following diagnostic workup:

      - History/physical examination =< 45 days prior to registration;

      - CT or MRI or positron emission tomography(PET)-CT that includes chest, abdomen
      and pelvis should be performed for initial radiological staging. This may be
      performed pre- or post-surgery ≤ 90 days prior to registration except in patients
      getting postoperative adjuvant chemotherapy, who will require CT, MRI or PET-CT
      including the chest and abdomen and pelvis no more than 30 days prior to
      registration. Imaging performed postoperatively should show no evidence of
      residual disease.

   - Age >=18

   - Zubrod performance status 0-2 =< 45 days prior to registration

   - Complete blood count (CBC)/differential obtained ≤ 14 days prior to registration with
   adequate bone marrow function defined as follows:

      - Absolute neutrophil count (ANC) >= 1,500 cells/mm^3

      - Platelets >= 100,000 cells/mm^3

      - Hemoglobin >= 8.0 g/dl (NOTE: the use of transfusion or other intervention to
      achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)

      - The patient must provide study-specific informed consent prior to study entry

   - The patient must provide study-specific informed consent prior to study entry.

Exclusion Criteria (Patients with any of the following conditions are NOT eligible for this

   - Definitive clinical or radiologic evidence of metastatic disease; pN3 disease is not
   allowed (positive common iliac node).

   - Prior invasive solid tumor or hematological malignancy (except non-melanomatous skin
   cancer and incidentally discovered prostate cancer at time of cystoprostatectomy)
   unless disease free for a minimum of 3 years

   - Prior radiotherapy to the pelvis

   - Patients with a history of inflammatory bowel disease

   - Patients who have required any treatment (medical or surgical) for bowel obstruction
   prior to diagnosis of bladder cancer or who have required surgical treatment for bowel
   obstruction after the cystectomy

   - Severe, active co-morbidity defined as follows:

      - Unstable angina and/or congestive heart failure requiring hospitalization within
      the last 6 months;

      - Transmural myocardial infarction within the last 6 months;

      - Acute bacterial or fungal infection requiring intravenous antibiotics at the time
      of registration;

      - Severe hepatic disease, defined as a diagnosis of Child-Pugh Class B or C hepatic

      - HIV positive with CD4 count < 200 cells/microliter. Note that patients who are
      HIV positive are eligible, provided they are under treatment with highly active
      antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within
      30 days prior to registration. Note also that HIV testing is not required for
      eligibility for this protocol.

      - Other major medical illness which requires hospitalization or precludes study
      therapy at the time of registration.

   - Women who are breastfeeding


radiation: Intensity-Modulated Radiation Therapy


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mark K. Buyyounouski