Clinical trial · Observational
Outcomes Study of Late Effects After Proton RT for Pediatric Tumors of the Brain, Head, and Neck
A Study of Late Effects After Proton Radiotherapy for Pediatric Tumors of the Brain, Head, and Neck
NCT01067196CI-TRIAL-00059019CN01completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to collect information from medical records to see what effects proton beam radiation has on cancer and analyze possible side effects.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Central Nervous System Tumors | Central Nervous System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Observation and quality of life
- description
- Central Nervous System Tumors
Primary outcomes (1)
- measure
- Measure late effects of proton therapy on pediatric patients with CNS tumors
- timeFrame
- 5.4 years after treatment completion
Secondary outcomes (1)
- measure
- Survival endpoints of local control, progression-free survival, and overall and cause-specific survival.
- timeFrame
- 12 years after treatment completion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Day
- Maximum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Estimated \>5 cc of the brain tissue to receive \>5 CGE radiation * Patient must be less than 21 years of age at time of consent. * Patients that require localized and craniospinal irradiation. * Patients and/or patient parent must complete baseline Quality of Life Questionnaire as applicable by patient age group. Exclusion Criteria: * Prior radiation therapy. * Evidence of metastases outside the central nervous system.
References
Publications (5)
- BACKGROUNDDuffner PK, Horowitz ME, Krischer JP, Friedman HS, Burger PC, Cohen ME, Sanford RA, Mulhern RK, James HE, Freeman CR, et al. Postoperative chemotherapy and delayed radiation in children less than three years of age with malignant brain tumors. N Engl J Med. 1993 Jun 17;328(24):1725-31. doi: 10.1056/NEJM199306173282401. PMID 8388548
- BACKGROUNDSklar CA, Constine LS. Chronic neuroendocrinological sequelae of radiation therapy. Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1113-21. doi: 10.1016/0360-3016(94)00427-M. PMID 7713777
- BACKGROUNDVarni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer. 2002 Apr 1;94(7):2090-106. doi: 10.1002/cncr.10428. PMID 11932914
- BACKGROUNDBhat SR, Goodwin TL, Burwinkle TM, Lansdale MF, Dahl GV, Huhn SL, Gibbs IC, Donaldson SS, Rosenblum RK, Varni JW, Fisher PG. Profile of daily life in children with brain tumors: an assessment of health-related quality of life. J Clin Oncol. 2005 Aug 20;23(24):5493-500. doi: 10.1200/JCO.2005.10.190. PMID 16110009
- BACKGROUNDHuang E, Teh BS, Strother DR, Davis QG, Chiu JK, Lu HH, Carpenter LS, Mai WY, Chintagumpala MM, South M, Grant WH 3rd, Butler EB, Woo SY. Intensity-modulated radiation therapy for pediatric medulloblastoma: early report on the reduction of ototoxicity. Int J Radiat Oncol Biol Phys. 2002 Mar 1;52(3):599-605. doi: 10.1016/s0360-3016(01)02641-4. PMID 11849779