Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma
Summary
This phase III trial is studying observation to see how well a risk based treatment strategy works in patients with soft tissue sarcoma. In the study, patients are assigned to receive surgery +/- radiotherapy +/- chemotherapy depending on their risk of recurrence. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.
Timeline
- Start
- 2007-02-05
- Primary completion
- 2014-09-05
- Completion
- 2022-03-31
Publications
- Crane JN, Xue W, Qumseya A, Barkauskas DA, Chau K, Tan SY, Hiniker S, Dasgupta R, Venkatramani R, Spunt SL, Weiss AR, Laetsch TW. Malignant peripheral nerve sheath tumors: a report from Children's Oncology Group study ARST0332. J Natl Cancer Inst. 2026 May 1;118(5):829-838. doi: 10.1093/jnci/djaf359.
- Alvarez E, He J, Spunt SL, Hayes-Jordan A, Kao SC, Parham DM, Million L, Weiss AR, Barkauskas DA. Lymph node metastases in paediatric and young adult patients with non-rhabdomyosarcoma soft tissue sarcoma (NRSTS): Findings from Children's Oncology Group (COG) study ARST0332. Eur J Cancer. 2023 Feb;180:89-98. doi: 10.1016/j.ejca.2022.11.014. Epub 2022 Nov 25.
- Venkatramani R, Xue W, Randall RL, Wolden S, Anderson J, Lopez-Terrada D, Black J, Kao SC, Shulkin B, Ostrenga A, Pappo A, Spunt SL. Synovial Sarcoma in Children, Adolescents, and Young Adults: A Report From the Children's Oncology Group ARST0332 Study. J Clin Oncol. 2021 Dec 10;39(35):3927-3937. doi: 10.1200/JCO.21.01628. Epub 2021 Oct 8.
- Million L, Hayes-Jordan A, Chi YY, Donaldson SS, Wolden S, Morris C, Terezakis S, Laurie F, Morano K, Fitzgerald TJ, Yock TI, Rodeberg DA, Anderson JR, Speights RA, Black JO, Coffin C, McCarville MB, Kao SC, Hawkins DS, Spunt SL, Randall RL. Local Control For High-Grade Nonrhabdomyosarcoma Soft Tissue Sarcoma Assigned to Radiation Therapy on ARST0332: A Report From the Childrens Oncology Group. Int J Radiat Oncol Biol Phys. 2021 Jul 1;110(3):821-830. doi: 10.1016/j.ijrobp.2021.01.051. Epub 2021 Feb 3.
- Spunt SL, Million L, Chi YY, Anderson J, Tian J, Hibbitts E, Coffin C, McCarville MB, Randall RL, Parham DM, Black JO, Kao SC, Hayes-Jordan A, Wolden S, Laurie F, Speights R, Kawashima E, Skapek SX, Meyer W, Pappo AS, Hawkins DS. A risk-based treatment strategy for non-rhabdomyosarcoma soft-tissue sarcomas in patients younger than 30 years (ARST0332): a Children's Oncology Group prospective study. Lancet Oncol. 2020 Jan;21(1):145-161. doi: 10.1016/S1470-2045(19)30672-2. Epub 2019 Nov 27.
- Spunt SL, Francotte N, De Salvo GL, Chi YY, Zanetti I, Hayes-Jordan A, Kao SC, Orbach D, Brennan B, Weiss AR, van Noesel MM, Million L, Alaggio R, Parham DM, Kelsey A, Randall RL, McCarville MB, Bisogno G, Hawkins DS, Ferrari A. Clinical features and outcomes of young patients with epithelioid sarcoma: an analysis from the Children's Oncology Group and the European paediatric soft tissue Sarcoma Study Group prospective clinical trials. Eur J Cancer. 2019 May;112:98-106. doi: 10.1016/j.ejca.2019.02.001. Epub 2019 Apr 5.
- Ferrari A, Chi YY, De Salvo GL, Orbach D, Brennan B, Randall RL, McCarville MB, Black JO, Alaggio R, Hawkins DS, Bisogno G, Spunt SL. Surgery alone is sufficient therapy for children and adolescents with low-risk synovial sarcoma: A joint analysis from the European paediatric soft tissue sarcoma Study Group and the Children's Oncology Group. Eur J Cancer. 2017 Jun;78:1-6. doi: 10.1016/j.ejca.2017.03.003. Epub 2017 Apr 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxorubicin | Other / unclassified | 37.5 mg/m2 | Intravenous |
| Subject | Ifosfamide | Small molecule | 3 g | Intravenous |