Bladder Cancer Adjuvant Radiotherapy Trial

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

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.

Eligibility Criteria:
Inclusion Criteria:

All patients should have undergone radical cystoprostatectomy for bladder cancer Patients with any of the below high risk features on histolopathology

* Lymph Node positive with or without perinodal extension (PNE)
* Cut-margin positive,
* pT3 and pT4 disease,
* Number of nodes dissected at surgery \< 10 All patients irrespective of the final pathology if they have received neo-adjuvant chemotherapy prior to surgery for any of the following T3 T4 stage N1-3 stage No evidence of distant metastasis including para-aortic nodal metastasis KPS ≥ 70 Signed study specific consent form Adequate hepatic, renal and hematologic parameters

Exclusion Criteria:

* Contraindication to pelvic radiotherapy like inflammatory bowel disease
* Uncontrolled diabetes or hypertension
* Uncontrolled cardiac or respiratory co morbidity
* Prior history of therapeutic irradiation to pelvis
* Patient unwilling and unreliable for follow up and QoL