Randomized Evidence

(In the process of being crosslinked)

• Anal canal
• Benign Diseases
• Bladder
• Brain Metastases
• Breast
• Cervix
• Cholangiocarcinoma
• Colon
• Endometrial
• Epilepsy
• Esophagus
• Gastric
• Gliomas
• Head & Neck
• Hodgkin's Disease
• Heel Spurs
• Kaposi's Sarcoma
• Lung, NSCLC
• Lung, SCLC
• Lymphoma, Non-Hodgkin's
• Medulloblastoma
• Mesothelioma
• Melanoma, Cutaneous
• Melanoma, Ocular
• Pancreas
• Prostate
• Rectum
• Sarcoma
• Skin Non-melanoma
• Spinal Cord Compression
• Superior Vena Cava Syndrome
• Testis, NSGCT
• Thymoma
• Vascular Brachytherapy
• Wilms' Tumor (Nephroblastoma)

• Hyperthermia
• Supportive Care
• RT Technology
• Proton Therapy

Literature

• Kentucky; 2009 PMID 19111269 -- "Randomized prospective trials of innovative radiotherapy technology are necessary." (Halperin EC, J Am Coll Radiol. 2009 Jan;6(1):33-7.)
  • "It is possible to identify innovations that should be required to meet the standard of proof of a benefit in a randomized prospective clinical trial before being introduced into widespread clinical practice."

• NCI Canada; 2008 (1975-2004) PMID 18955452 -- "Evolution of the Randomized Controlled Trial in Oncology Over Three Decades." (Booth CM, J Clin Oncol. 2008 Oct 27. [Epub ahead of print])
  • 321 reports evaluating RCT in systemic therapy for breast, CRC, and NSCLC reviewed.
  • Outcome: Number and size of RCT increased substantially. For profit sponsorship increased substantially (4% to 57%, SS). Effect size remained stable, but authors have become more likely to strongly endorse experimental arm (SS). Endorsement of experimental arm strongly associated with industry sponsorship

• Wisconsin; 2008 PMID 18237799 -- "Randomized controlled trials in health technology assessment: Overkill or overdue?" (Bentzen SM, Radiother Oncol. 2008 Jan 29 [Epub ahead of print])

• Oxford; 2007 PMID 17303884 -- "When are randomised trials unnecessary? Picking signal from noise." (Glasziou P, BMJ. 2007 Feb 17;334(7589):349-51.)

• RTOG; 2005 (1968-2002) PMID 15728168 -- "Evaluation of new treatments in radiation oncology: are they better than standard treatments?" (Soares HP, JAMA. 2005 Feb 23;293(8):970-8.)
  • Review of all completed Phase III RTOG trials. 57 trials, 12734 patients
  • Outcome: survival OR for intervention arm over standard arm 1.01 (NS). Only 10% significantly better, 88% inconclusive
  • Toxicity: treatment-related mortality intervention arm worse OR 1.76 over standard arm (SS)
  • Conclusion: Results of individual trials cannot be predicted in advance

• COG; 2005 (1955-1997) PMID 16299015 -- "Are experimental treatments for cancer in children superior to established treatments? Observational study of randomised controlled trials by the Children's Oncology Group." (Kumar A, BMJ. 2005 Dec 3;331(7528):1295. Epub 2005 Nov 18.)
  • Review of completed Phase III trials. 126 trials, 36567 patients
  • Outcome: survival OR 0.96 (NS)
  • Conclusion: New treatments in childhood cancer are as likely to be inferior as they are to be superior to standard treatments