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Protocol Summary National Wilms Tumor Study Group (NWTS)

Protocol Summary National Wilms Tumor Study Group (NWTS). Patty Sponseller, CMD DOS741 Protocols and Studies in Radiation Oncology 2011. History. Established 1969 Brought together investigators already participating in cooperative groups Founding Chairman, Dr. Guilio D’ Angio

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Protocol Summary National Wilms Tumor Study Group (NWTS)

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  1. Protocol SummaryNational Wilms Tumor Study Group (NWTS) Patty Sponseller, CMD DOS741 Protocols and Studies in Radiation Oncology 2011

  2. History • Established 1969 • Brought together investigators already participating in cooperative groups • Founding Chairman, Dr. Guilio D’ Angio • Vision cure childhood cancers, particularly Wilms tumor

  3. History of NWTS • Established in 1969 • Original Institutions from Children’s Cancer Group and Pediatric Division of SWOG and CALBG • In 2001 NWTSG and Intergroup Rhabdomyosarcoma Study Group to form new organization Children’s Oncology Group (COG) • Patient entry in NWTSG ended in 2002 • Subsequent and future trials for children with renal tumors are conducted by COG • NWTS is still a destination used only for studying late effects of patients originally enrolled http://www.nwtsg.org

  4. Combined Efforts • Only 500 cases diagnosed annually • Single or small groups of institutions not enough patients to study • Investigators and Institutions agreed to combine efforts • Goal was to get answers in a short period of time

  5. Vision • Survivors could lead normal adult lives • Free of late effects caused by treatment • NWTS pioneer in multi-modal treatment • Included all professions as full members

  6. Goals • Improve survival • Children with Wilms tumors or other renal tumors • Study long-term outcomes • Study epidemiology and biology of Wilms tumors • Make this information available world wide

  7. How would these children benefit? • Investigators wanted answers to long standing therapy ?’s • Determine risks • Gauge outcomes • Results – better treatment

  8. NWTS Trials • Conducted 5 trials • Determine which drugs or combinations • Decrease the radiation dose • Enrolled more than 400 children/year • 70% of Wilms Tumor patients in United States • 33 year span

  9. Control • Each study identified objectives which included the original objectives • New study built on results of previous study • Resulted in improvements • 1st trial already showed diminished late effects

  10. NWTS-1 • October 1969 to February 1975 • Accrued 741 patients • Results – No RT to low risk Group I Drug combinations more effective Favorable and unfavorable histologic classifications

  11. NWTS-2 • January 1975 to April 1979 • Accrued 950 patients • Results – Group I treated for 6 months ADR improved outcomes for Groups I & II Chemotherapy doses for babies Prognosis for favorable and unfavorable Grouping redefined and new staging

  12. NWTS-3 • May 1979 to September 1986 • Accrued 2496 patients • Results – Patients divided into 2 Groups Stage I FH or focal anaplasia no RT Stage III FH best with 3 drugs Stage III-IV 4 drugs

  13. NWTS-4 • August 1986 to August 1995 • Accrued 3335 patients • Results – “pulse intensive” drug doses Cost of therapy decreased

  14. NWTS-5 • August 1995 to May 2002 • Accrued 3031 patients • Results – Chromosomes tagged to outcome Surgery alone adequate Patients with pulmonary mets may benefit with doxorubicin

  15. Results Radiotherapy Regiment • Patients are treated on COG study • Result of 5 trials dropped (FH) dose to abdomen to 1080 cGy and 1200 cGy whole lung • Post-op RT start 14 days after surgery • RT limited to Stages III and IV only • Stage IV (FH) with pulmonary nodules after RT receive whole lung RT

  16. Present Day • Late effects study • Includes only those enrolled in one of the original NWTS trials • Determines risks and mortality rates • Contributions to genetic epidemiology

  17. Eligibility • Participants must have been consented for one of the original trials • Participant must have been registered • All trial data was submitted to NWTS • Tissue sent to central Pathology of NWTS • Diagnosis Wilms, clear cell sarcoma of kidney or rhabdoid tumor of kidney

  18. Success • Answers to long standing ?’s in a short time frame • Accomplished by a multi-modal group • Careful data collection and follow up • Research continues to lead to improvements • Now carried out by COG

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