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NCT03819985 · ClinicalTrials.gov registry record · Phase 2
Shorter Course, Hypofractionated Pre-Surgery Radiation Therapy in Treating Patients With Localized, Resectable Soft Tissue Sarcoma of the Extremity of Superficial Trunk
A Phase 2 study of Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 and Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 122
- Enrollment target
- 1
- Study location
NCT03819985: Active Phase 2 study of Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 and Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, sponsored by M.D. Anderson Cancer Center.
NCT03819985 is a Phase 2 study of Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 and Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 122 participants, below the 186-participant average among 4 other Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 trials with a reported enrollment target (34% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03819985, a Phase 2 study of Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 and Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 122 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies the wound complication risk of shorter course, hypofractionated pre-surgery radiation therapy in treating patients with localized soft tissue sarcoma of the extremity of superficial trunk that can be removed by surgery. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Shorter course hypofractionated pre surgery radiation therapy may be more convenient for patients with soft tissue sarcoma than a longer course of radiation therapy, and may result in fewer complications.
Primary Outcome
A Bayesian approach for the analysis of a stopping rule of higher acute wound complications for the new dose (E) will be employed.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- RADIATION Hypofractionated Radiation Therapy
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2018-12-17 |
| Est. Completion | 2027-08-31 |
| Phase | Phase 2 |
What the registry record for NCT03819985 still lists
NCT03819985 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, below the 186-participant average among 4 other Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 trials with a reported enrollment target (34% lower).
The record links to 8 conditions, with Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 appearing as the primary indexed condition, and to 3 interventions - of which Quality-of-Life Assessment is the first listed.
NCT03819985 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03819985 about?
NCT03819985 is a clinical study titled "Shorter Course, Hypofractionated Pre-Surgery Radiation Therapy in Treating Patients With Localized, Resectable Soft Tissue Sarcoma of the Extremity of Superficial Trunk". This phase II trial studies the wound complication risk of shorter course, hypofractionated pre-surgery radiation therapy in treating patients with localized soft tissue sarcoma of the extremity of superficial trunk that can be removed by surgery. Hypofractionated radiation therapy delivers higher d...
What is the current status of trial NCT03819985?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 122 participants. The study started on 2018-12-17. Estimated completion is 2027-08-31.
What conditions does trial NCT03819985 study?
This clinical trial studies the following conditions: Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, Resectable Soft Tissue Sarcoma, Stage IIIA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, Stage IIIB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8.
What interventions are being tested in trial NCT03819985?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Hypofractionated Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT03819985?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03819985 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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