Aim and objectives: This trial aims to evaluate the role of adjuvant radiotherapy following chemotherapy in patients with high-risk features on histo-pathology after radical surgery for transitional cell carcinoma of urinary bladder

Brief Title

Bladder Cancer Adjuvant Radiotherapy Trial

Official Title

Prospective Randomized Trial of Adjuvant Radiotherapy Following Surgery and Chemotherapy in Muscle Invasive Transitional Cell Carcinoma of Urinary Bladder

Brief Summary

Aim and objectives: <br /> <br /> This trial aims to evaluate the role of adjuvant radiotherapy following chemotherapy in <br /> patients with high-risk features on histo-pathology after radical surgery for transitional <br /> cell carcinoma of urinary bladder

Detailed Description

Treatment details:

Surgery(Standard/routine care) All patients would have undergone radical surgery in the form
of a cysto-prostatectomy and pelvic nodal dissection as part of their standard care. Patients
would also have a urinary diversion (Ileostomy) or a continent neo bladder.

Chemotherapy All patients following cysto-prostatectomy will receive upto 4 cycles of
adjuvant chemotherapy if medically fit for the same. Those patients who received neoadjuvant
chemotherapy, will receive additional chemotherapy cycle after surgery to a total of 4 cycles
if found suitable. The chemotherapy regimen, doses and schedule will be as per standard
institutional practice using Platinum based chemotherapy. No concomitant chemotherapy with
radiotherapy is recommended.

Radiation therapy:

All patients will be treated with conformal radiotherapy technique with intensity modulated
radiotherapy with or without image guidance. The radiotherapy will start within maximum of 8
weeks from the date of surgery if adjuvant chemotherapy has not been planned. If adjuvant
chemo planned the patients will receive radiotherapy within 4 weeks of the last chemo cycle.

Dose Prescription:

50.4Gray (Gy) in 28fractions (1.8Gy/#) will be prescribed for the nodal PTV. In case of R1
and/or R2 resection dose to the pelvic nodes and tumour bed may be increased to 54-56Gy in 28
fractions depending on the constraints achieved during planning.

Clinical assessment:

1. Toxicity will be assessed by

1. Weekly physician assessment during RT with scoring of toxicity.

2. RTOG toxicity criteria at baseline, 6-8 weeks post RT and at 3 monthly thereafter
for 2 years and 6 monthly thereafter for 5 years.

3. QOL will be assessed at baseline and 3-6 monthly thereafter

2. Disease evaluation The first follow up all patients will be done at 6-8 week to assess
toxicity. Clinical evaluation of the disease will be done at each follow up visits by
clinical examination. CT scan of the abdomen and pelvis will be done 6 monthly from
second visit onwards up to 2 years and 12 monthly thereafter or whenever clinically
indicated as decided by the physician.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.