Stereotactic Radiation Therapy for Pediatric Sarcomas
Maneno muhimu
Kikemikali
Maelezo
Pediatric patients with sarcoma who have limited metastases are still potentially curable with aggressive local therapy. However, conventional moderate dose radiation is unlikely to provide durable local control. Given the recent technologic advances in radiation delivery, it is now possible to deliver tumoricidal doses, using stereotactic radiation over a short time course with highly focal techniques. Stereotactic radiation has proven efficacious in the intracranial setting and in multiple extracranial sites in adults. It has not yet been well studied in the pediatrics population where there is a particularly strong rationale due to the ablative doses that can be delivered to tumor while simultaneously reducing high dose to normal tissues. The proposed trial is a single arm phase II study to determine the efficacy of SBRT in pediatric sarcomas with surgically unresectable metastatic disease. Oligometastatic sites eligible for treatment in this study include bony sites of disease. SBRT will be delivered to each eligible site to a total dose of 4000 delivered in 5 fractions of 800 per fractions each day. Following completion of SBRT, patients will undergo treatment response assessment with the use of diagnostic imaging, clinical examination, and completion of the Brief Pain Inventory to assess quality of life. The primary objective of this study is to determine the efficacy of SBRT delivered to a dose of 4000 centigray (cGy) in 5 fractions of 800 cGy each for patients greater than 3 years of age and < 40 years of age with metastatic disease of bone secondary to pediatric sarcoma. The secondary objectives of this study include describing the toxicity of SBRT with this regimen; assessing clinical response rate of each target lesion; assessing long-term clinical outcomes; and assessing quality of life following completion of treatment. For patients with potentially curable oligometastatic disease, surgical resection in conjunction with systemic therapy remains the standard of care. Patients on this study will continue to receive chemotherapy outside of the 2 week window for SBRT. Issues that may limit participation include our inability to assess late effects that may not develop till at least 10 years after therapy. For this reason, we will limit the population in this study to patients who are surgically unresectable and would be otherwise incurable with current standard systemic therapies.
Tarehe
| Imethibitishwa Mwisho: | 07/31/2020 |
| Iliyowasilishwa Kwanza: | 01/06/2013 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 01/07/2013 |
| Iliyotumwa Kwanza: | 01/08/2013 |
| Sasisho la Mwisho Liliwasilishwa: | 08/12/2020 |
| Sasisho la Mwisho Lilichapishwa: | 08/26/2020 |
| Tarehe ya matokeo ya kwanza yaliyowasilishwa: | 08/12/2020 |
| Tarehe ya matokeo ya kwanza ya QC yaliyowasilishwa: | 08/12/2020 |
| Tarehe ya matokeo ya kwanza kuchapishwa: | 08/26/2020 |
| Tarehe halisi ya kuanza kwa masomo: | 10/31/2013 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 09/23/2018 |
| Tarehe ya Kukamilisha Utafiti: | 03/31/2020 |
Hali au ugonjwa
Uingiliaji / matibabu
Radiation: Hypofractionated SBRT
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| Experimental: Hypofractionated SBRT 800 cGy delivered in 5 fractions every day to total dose of 4000 cGy | Radiation: Hypofractionated SBRT |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 4 Years Kwa 4 Years |
| Jinsia Inastahiki Kujifunza | All |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | Inclusion Criteria: - histologically or cytologically confirmed metastatic sarcoma of the soft tissue or bone - must have measurable disease - disease must be surgically unresectable as determined by a tumor board or surgeon - greater than 3 years of age - less than or equal to 40 years of age - life expectancy of at least 9 months - adequate performance status (Lansky Performance Status greater than or equal to 50). - ability to understand and willingness to sign informed consent document Exclusion Criteria: - patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study - patients who have had any prior radiotherapy to the treatment site(s) - patients may not participate on any other treatment protocol while they are receiving treatment on this protocol and for up to 3 months after these protocol treatments have ended - pregnant women - refusal of women of child bearing potential to take a pregnancy test prior to treatment |
Matokeo
Hatua za Matokeo ya Msingi
1. Lesion-specific Local Control at 6 Months Post-SBRT as Assessed by Percentage of Lesions Locally Controlled [6 months post-SBRT]
Hatua za Matokeo ya Sekondari
1. Patient-specific Local Control at 6 Months Post-SBRT as Assessed by the Percentage of Patients Locally Controlled [6 months post-SBRT]
2. Percentage of Patients With Progression-free Survival at 6 Months Post-SBRT [6 months post-SBRT]
3. Percentage of Patients With Overall Survival at 6 Months Post-SBRT [6 months post-SBRT]
4. Change in Quality of Life (QoL) as Assessed by the Brief Pain Inventory [Baseline and one-month post-SBRT]
5. Number of Participants Experiencing Toxicity of SBRT [12 months after treatment starts]
