Clinical trial · Interventional
Proton Chemoradiotherapy for High-Risk Soft Tissue Sarcomas
A Pilot Study Investigating Neoadjuvant Temozolomide-based Proton Chemoradiotherapy for High-Risk Soft Tissue Sarcomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No patients accrued since study opened
Summary
Brief summary (as posted)
The goal of this study is to evaluate the effects of temozolomide and radiation combination in the treatment intended of soft tissue sarcomas. This study will also look at the tumor tissue that was removed during your initial biopsy and your final surgery for information that may help to treat soft tissue sarcoma in the future. In addition the investigators will examine a sample of your normal tissue (optional) from the inside of your mouth/cheek (to compare it to your tumor tissue) before starting treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcomas | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemoradiotherapy Temozolomide | Drug | — | UNRESOLVED |
| Proton Chemoradiotherapy followed by surgery | Procedure | — | UNRESOLVED |
| Proton therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Proton Chemoradiotherapy followed by surgery
- description
- Proton Chemoradiotherapy followed by surgery. Temozolomide five days per week during radiotherapy for 5 weeks. Proton radiation five days per week for 5 weeks Standard surgery will take place 4-6 weeks after completion of chemoradiation.
- interventionNames
- Procedure: Proton Chemoradiotherapy followed by surgery
- type
- ACTIVE_COMPARATOR
- label
- Chemoradiotherapy Temozolomide
- description
- Chemoradiotherapy Temozolomide: 75 mg/m2 five days per week during radiotherapy for 5 weeks. Temozolomide should be taken orally 1 hour before each session of radiotherapy during weekdays (Monday through Friday). The dose will be determined using the body surface area (BSA) calculated at the beginning of the concurrent treatment. The BSA will be calculated from the height obtained at the pretreatment visit and the weight obtained before the first day of treatment. The concurrent treatment will last until the end of radiotherapy.
- interventionNames
- Drug: Chemoradiotherapy Temozolomide
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologic and radiographic proof of localized high-risk soft tissue sarcoma (STS) required prior to registration. * For the purpose of this study, high risk STS is defined by at least two of the following risk factors: * Tumor ≥ 5 cm in maximal diameter on MRI or CT * Histology grade 3 or 4 (AJCC, 7th edition) * Tumor deep to the investing fascia * Locally recurrent sarcoma with no prior radiation therapy to the primary site * Age \>55 years old * Tumor must be considered potentially resectable as defined by cross sectional imaging. * At least 2 weeks must have elapsed from any prior surgery or hormonal therapy. Patients must have ≤ grade 1 acute toxicities of any prior treatment with anti-cancer modalities (returned to baseline status as noted before most recent treatment). Patients with persisting, stable chronic toxicities from prior treatment ≤ grade 1 are eligible. * Age ≥18 years at time of consent. * Physician documented life expectancy of greater than 3 months. * Patients must have normal organ and marrow function within 4 weeks prior to study treatment as defined below: * hemoglobin ≥ 9 g/dL * leukocytes ≥3,000/microliter (mcL) * absolute neutrophil count ≥1,500/mcL * platelets ≥100,000/mcL * total bilirubin ≤ institutional upper limit of normal * aspartate aminotransferase (AST/SGOT) and alanine aminotransferase(ALT/SGPT) \< 2.5 x institutional upper limit of normal * creatinine within 1.5 x upper limit of normal(ULN) * Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for 12 months after treatment. Patients must have a negative serum pregnancy test within 14 days prior to beginning treatment on this trial. Sexually active men must also use appropriate contraception method and should not father a child while receiving therapy during this study. * Ability to understand and the willingness to sign a written Institutional Review Board(IRB) stamped, study specific informed consent document prior to any research related procedures or study treatment. Exclusion Criteria: * Receiving any investigational agents. * Treatment with cytotoxic agents and/or treatment with biologic agents within the 4 weeks prior to beginning treatment on this study. * Evidence of metastatic disease. * Previous radiotherapy to the affected site. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, and/or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study because the investigational agents may have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued if the mother is treated. * HIV-positive patients are ineligible because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy and the potential pharmacokinetic interaction between antiretroviral therapy and the investigational agents. * All herbal and/or alternative medications should be discontinued while on study, these include but are not limited to: Hydrastis canadensis (goldenseal), Uncaria tomentosa (cat's claw) or Echinacea angustifolia. * Requirement for treatment with immunosuppressive agents or chronic steroids. * A history of a hypersensitivity reaction to any of temozolomide's components or to Dacarbazine(DTIC).
References
Publications (100)
- BACKGROUNDAnderson P, Aguilera D, Pearson M, Woo S. Outpatient chemotherapy plus radiotherapy in sarcomas: improving cancer control with radiosensitizing agents. Cancer Control. 2008 Jan;15(1):38-46. doi: 10.1177/107327480801500105. PMID 18094659
- BACKGROUNDJemal A, Tiwari RC, Murray T, Ghafoor A, Samuels A, Ward E, Feuer EJ, Thun MJ; American Cancer Society. Cancer statistics, 2004. CA Cancer J Clin. 2004 Jan-Feb;54(1):8-29. doi: 10.3322/canjclin.54.1.8. PMID 14974761
- BACKGROUNDPollock RE, Karnell LH, Menck HR, Winchester DP. The National Cancer Data Base report on soft tissue sarcoma. Cancer. 1996 Nov 15;78(10):2247-57. PMID 8918421
- BACKGROUNDEilber FC, Rosen G, Nelson SD, Selch M, Dorey F, Eckardt J, Eilber FR. High-grade extremity soft tissue sarcomas: factors predictive of local recurrence and its effect on morbidity and mortality. Ann Surg. 2003 Feb;237(2):218-26. doi: 10.1097/01.SLA.0000048448.56448.70. PMID 12560780
- BACKGROUNDPisters PW, Harrison LB, Leung DH, Woodruff JM, Casper ES, Brennan MF. Long-term results of a prospective randomized trial of adjuvant brachytherapy in soft tissue sarcoma. J Clin Oncol. 1996 Mar;14(3):859-68. doi: 10.1200/JCO.1996.14.3.859. PMID 8622034
- BACKGROUNDRhomberg W, Hassenstein EO, Gefeller D. Radiotherapy vs. radiotherapy and razoxane in the treatment of soft tissue sarcomas: final results of a randomized study. Int J Radiat Oncol Biol Phys. 1996 Dec 1;36(5):1077-84. doi: 10.1016/s0360-3016(96)00433-6. PMID 8985029
- BACKGROUNDRosenberg SA, Tepper J, Glatstein E, Costa J, Baker A, Brennan M, DeMoss EV, Seipp C, Sindelar WF, Sugarbaker P, Wesley R. The treatment of soft-tissue sarcomas of the extremities: prospective randomized evaluations of (1) limb-sparing surgery plus radiation therapy compared with amputation and (2) the role of adjuvant chemotherapy. Ann Surg. 1982 Sep;196(3):305-15. doi: 10.1097/00000658-198209000-00009.