bladder cancer adjuvant radiotherapy trial

Conditions: Bladder Cancer; Urothelial Carcinoma Bladder

Summary: 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

Keywords: adjuvant rt