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NCT01819831 · ClinicalTrials.gov registry record · NA
A Phase II Trial of Preoperative Proton Therapy in Soft-tissue Sarcomas of the Extremities and Body Wall
A NA study, sponsored by Loma Linda University.
- Completed
- Registry status
- NA
- Development phase
- 7
- Enrollment target
NCT01819831: Completed NA study, sponsored by Loma Linda University.
NCT01819831 is a NA study that has completed, run by Loma Linda University. The registered enrollment target is 7 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01819831, a NA study, has completed, sponsored by Loma Linda University.
- COMPLETED
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
Study Summary
When treated with surgery alone, many soft-tissue sarcomas have a high chance of coming back. Radiation therapy is frequently used in addition to surgery to reduce the chances of the sarcoma coming back. However, radiation can have long-term side effects on the normal tissues surrounding the tumor, leading to problems such as swelling, scarring, and joint stiffness. Recently, there have been advances in the way that radiation therapy can be given. Proton radiation therapy is one of those advances. With proton radiation, it is possible to give radiation over a smaller area surrounding the tumor, resulting in less radiation to the surrounding normal tissues. The purpose of this study is to determine whether proton radiation decreases the long-term side effects of radiation on normal tissues and if smaller proton radiation fields reduce local recurrence compared to the larger radiation fields that have been used in prior studies.
Primary Outcome
To report the number of participants with late radiation morbidity Late subcutaneous fibrosis and joint stiffness are assessed using the European Organization for Research and Treatment of Cancer/Radiation Therapy Oncology Group (EORTC/RTOG) late toxicity scoring criteria below: Subcutaneous tissue: Grade 1(slight fibrosis; subcutaneous fat loss), Grade 2(moderate fibrosis: slight field contracture), Grade 3(severe fibrosis; field contracture \>10%), Grade 4(necrosis), Grade 0 (none) Joint sti
Interventions
- RADIATION proton radiation
- PROCEDURE surgery (wide local excision; limb preservation surgery)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2013-02-27 |
| Est. Completion | 2022-05-19 |
| Phase | NA |
What the finished NCT01819831 record still lists
NCT01819831 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which proton radiation is the first listed.
NCT01819831 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01819831 about?
NCT01819831 is a clinical study titled "A Phase II Trial of Preoperative Proton Therapy in Soft-tissue Sarcomas of the Extremities and Body Wall". When treated with surgery alone, many soft-tissue sarcomas have a high chance of coming back. Radiation therapy is frequently used in addition to surgery to reduce the chances of the sarcoma coming back. However, radiation can have long-term side effects on the normal tissues surrounding the tumor, ...
What is the current status of trial NCT01819831?
This trial is currently completed. It is a NA study. The enrollment target is 7 participants. The study started on 2013-02-27. Estimated completion is 2022-05-19.
What interventions are being tested in trial NCT01819831?
The interventions under investigation include: proton radiation (RADIATION), surgery (wide local excision; limb preservation surgery) (PROCEDURE).
Who is sponsoring clinical trial NCT01819831?
This trial is sponsored by Loma Linda University, which has 237 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01819831's enrollment target sits among peer trials
7 1982nd of 2000 higher than 18 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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