Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04946357
Other study ID # EXTREM ION
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 21, 2021
Est. completion date July 1, 2025

Study information

Verified date January 2024
Source University Hospital Heidelberg
Contact Klaus Herfarth, Prof. Dr.
Phone 06221 56 34093
Email studienkoordination.RAD@med.uni-heidelberg.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized prospective open-label phase 2 trial testes the safety and feasibility of a hypofractionated accelerated neoadjuvant proton or carbon ion radiotherapy based on the rate of wound healing disorders from beginning of radiotherapy to maximum 120 days after the planned tumor resection or discontinuation of treatment due to any reason. The treatment is of shorter duration (2-3 weeks vs. 5 weeks standard treatment), which should please most patients and thus enhance quality of life. The treatment regimen furthermore promises a reduced rate of late side effects and significant optimization of the current treatment standards. A phase II trial is mandatory not only for obtaining the safety and feasibility data, but also in order to prepare a concurrent phase III trial. Due to the low incidence of soft tissue sarcoma, only a well prepared multicenter study has a chance to be successfully completed based on previous experiences in trials for seldom tumor entities.


Description:

Oncologic complete local excision (wide resection) combined with radiotherapy forms the standard treatment for patients with soft tissue sarcoma. Especially patients with G2/G3 sarcomas profit from the combination of radiotherapy and surgery. Well-differentiated sarcomas (G1) after total resection (R0) receive no subsequent treatment besides surgery. The sequence of surgery and radiation therapy is widely discussed by the radiation oncologists and surgeons. The main advantages of neoadjuvant (pre-operative) radiotherapy are the smaller treatment target volumes and reduced prescribed radiation doses of 50 Gy vs. 66 Gy (postoperative) in 2 Gy single doses. Thus, due to these reductions in volumes and dose, neoadjuvant radiotherapy is associated with a lower rate of radiotherapy-associated edema and fibrosis. However, a randomized phase III study showed an increased rate of wound healing complications in patients with neoadjuvant radiotherapy compared to adjuvant (post-operative) radiotherapy (35% vs. 17%). For this reason, adjuvant radiotherapy in is currently preferred in cases with good operability. Particle therapy bears the chance to utilize the advantages of preoperative radiotherapy without compromising wound healing. The advantages of tumor treatment by ion therapy are based on their special biological and physical features. Protons and carbons ion lead to an improved dose distribution compared to photons which allows an improved sparing of the neighboring risk organs and at the same time an escalation of the dose prescribed to the tumor. Carbon ions are furthermore superior to protons by biological advantages based on their enhanced biological effectivity. In general, heavy ions are considered as a good treatment option for tumors of low radiosensitivity as sarcomas. Superior survival and decreased toxicity rates are expected from the use of protons and carbon ions. This randomized prospective open-label phase 2 trial testes the safety and feasibility of a hypofractionated accelerated neoadjuvant proton or carbon ion radiotherapy based on the rate of wound healing disorders from beginning of radiotherapy to maximum 120 days after the planned tumor resection or discontinuation of treatment due to any reason. The treatment is of shorter duration (2-3 weeks vs. 5 weeks standard treatment), which should please most patients and thus enhance quality of life. The treatment regimen furthermore promises a reduced rate of late side effects and significant optimization of the current treatment standards. A phase II trial is mandatory not only for obtaining the safety and feasibility data, but also in order to prepare a concurrent phase III trial. Due to the low incidence of soft tissue sarcoma, only a well prepared multicenter study has a chance to be successfully completed based on previous experiences in trials for seldom tumor entities.


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date July 1, 2025
Est. primary completion date July 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histologically confirmed soft-tissue sarcoma of the extremities with an indication for perioperative radiation treatment - Resectable or marginally resectable - Karnofsky index of = 70% - Age = 18 years - Carried out patient education and written consent - Patient is capable to give informed consent Exclusion Criteria: - Stage IV (distant metastases) - Lymph node metastasis - Metal implants that influence treatment planning with ions - Previous radiotherapy in the treatment area - Desmoid tumors - Simultaneous participation in another clinical trial that could influence the results of the study. - Active medical implants for which no ion beam irradiation permit exists at the time of treatment (e.g., cardiac pacemaker, defibrillator)

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Protons
proton irradiation with a total dose of 39 Gy(RBE) in 3 Gy(RBE) fractions
carbon ions
carbon ion irradiation with a total dose of 39 Gy(RBE) in 3 Gy(RBE) fractions

Locations

Country Name City State
Germany University Hospital Heidelberg, Department of RadioOncology Heidelberg Baden-Württemberg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of therapies without wound healing disorders and/or discontinuation Proportion of therapies without wound healing disorders and / or discontinuation in each study arm. from the beginning of radiotherapy (day1) until a maximum of 120 days after the resection
Secondary LC: Local control LC: Local control determined from local onset to local tumor progression from start of radiotherapy to local onset to local tumor progression up to 5 years
Secondary LPFS: locally progression-free survival determined from onset of therapy to local tumor progression LPFS: locally progression-free survival determined from onset of therapy to local tumor progression from start of radiotherapy to onset of therapy of local tumor progression up to 5 years
Secondary DFS: Disease-free survival DFS: Disease-free survival determined from onset of therapy until local and / or distant tumor progression from start of radiotherapy to onset of therapy until local and / or distant tumor progression up to 5 years
Secondary OS: Overall survival OS: Overall survival until death or censorship from start of radiotherapy until death or censorship up to 5 years
See also
  Status Clinical Trial Phase
Recruiting NCT02910895 - A Platform of Patient Derived Xenografts (PDX) and 2D/3D Cell Cultures of Soft Tissue Sarcomas (STS) N/A
Recruiting NCT05621668 - A First-In-Human Phase 1 Trial of T-Cell Membrane-Anchored Tumor Targeted Il12 (Attil12)- T-Cell Therapy in Subjects With Advanced/Metastatic Soft Tissue and Bone Sarcoma Phase 1
Active, not recruiting NCT04032964 - Dose Finding Study of L19TNF and Doxorubicin in Patients With STS Phase 1
Active, not recruiting NCT04577014 - Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma Phase 1/Phase 2
Completed NCT01650077 - Therapeutic Response of Patients With Soft Tissue Sarcoma According to CHOI Criteria
Withdrawn NCT04906876 - A Phase 2 Study of 9-ING-41Combined With Chemotherapy in Adolescents and Adults With Advanced Sarcomas Phase 2
Terminated NCT02890368 - Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides Phase 1
Terminated NCT02628535 - Safety Study of MGD009 in B7-H3-expressing Tumors Phase 1
Completed NCT02204111 - Patient Directed Intervention to Improve the Quality of Life for Patients With Soft Tissue Sarcoma
Withdrawn NCT01663090 - Ferumoxytol-Enhanced MRI in Adult/Pedi Sarcomas N/A
Completed NCT01440088 - A Trial of TH-302 in Combination With Doxorubicin Versus Doxorubicin Alone to Treat Patients With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma Phase 3
Completed NCT01259375 - Amrubicin Chemotherapy as First Line in Metastatic or Unresectable Soft Tissue Sarcoma Phase 2
Completed NCT01106872 - Bevacizumab, Chemotherapy and Valproic Acid in Advanced Sarcomas Phase 1
Recruiting NCT00753727 - Sunitinib and Radiation in Patients With Resectable Soft-tissue Sarcoma Phase 1/Phase 2
Terminated NCT00755261 - Phase II Study of Doxorubicin and Avastin® in Sarcoma. Phase 2
Completed NCT00611078 - Environmental Pollutants and the Risk of Soft Tissue Sarcoma: A Pilot Study N/A
Completed NCT00580320 - Safety Study of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma Phase 1
Completed NCT03452644 - US-Guided Biopsy in the Diagnosis of Musculoskeletal Soft-Tissue Tumors
Recruiting NCT05539677 - Biobank and Register of Patients With Agresive Tumors for Translational and Analytical Research
Terminated NCT03520959 - A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702) Phase 3