Proton beam radiation
RadiationOnce per day, 5 days a week for a total of 4 to 6 weeks.
NCT Number: NCT00592592
The main purpose of this study is to see if using proton beam radiation therapy instead of photon beam radiation therapy can reduce side effects from radiation treatment for rhabdomyosarcoma. Photon beam radiation is the standard type of radiation for treating most rhabdomyosarcoma and many other types of cancer. Photon beam radiation enters the body and passes through healthy tissue, encounters the tumor, then leaves the body through healthy tissue. A beam of proton radiation enters the body and passes through healthy tissue, encounters tumor, but then stops. This means that less healthy tissue is affected by proton beam radiation than by photon beam radiation.
Looking for future studies?
Notify MeUp to 30 year
All sexes
Interventional
Not applicable
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Once per day, 5 days a week for a total of 4 to 6 weeks.
Time frame: 5 years from the start of radiation treatment
Cumulative incidence of participants who experienced a toxicity defined as either grade 3, 4, or 5 after the completion of radiation therapy in pediatric patients with pediatric rhabdomyosarcomas. Late toxicity is scored on a yearly follow-up basis for at least five years. Late toxicities will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. Cumulative incidence is shown at 5 years follow-up.
Time frame: 3 months from radiation treatment
Percentage of participants who experienced an acute toxicity following completion of radiation treatment by grade. Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. The recommended evaluation time for acute toxicity after radiotherapy was 6 weeks following completion, but may be at any time during the 3 months after treatment. Acute toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. Toxicities are graded on a scale of 1 to 5. A higher grade indicates a worse outcome with 1 being mild, 4 being life-threatening, and 5 being death.
Time frame: 4 years from the start of radiation treatment
Comparison of dose distribution to tumor and surrounding normal structures using dose volume histograms (DVH) generated from the proton plan used to treat the patient and the photon plan generated for comparison purposes. Percent of normal tissue spared was calculated using the following equation: (100 x (mean x-ray dose - mean proton dose))/mean X-ray dose. No measure of dispersion was calculated for these estimates. The data is no longer available.
Time frame: 5 years from the start of radiation therapy
Estimated survival probability (defined as being free of a local recurrence) was calculated using Grays formula for competing risks
Massachusetts General Hospital
Other
A Phase II Trial of Proton RT for the Treatment of Pediatric Rhabdomyosarcoma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02945800
Disease Attributes, Ewing Sarcoma
Birmingham, Alabama, United States
View Trial DetailsNCT01625351
Adenocarcinoma, Adenocarcinoma, Clear Cell
Memphis, Tennessee, United States
View Trial DetailsNCT02415816
Myosarcoma, Neoplasms
Memphis, Tennessee, United States
View Trial DetailsNCT01858168
Ewing Sarcoma, Myosarcoma
Boston, Massachusetts, United States
View Trial Details