Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03680430
Other study ID # ADAPTO-SARC-IPC 2017-030
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 20, 2019
Est. completion date September 20, 2020

Study information

Verified date September 2018
Source Institut Paoli-Calmettes
Contact Dominique Genre, MD
Phone +334912233778
Email drci.up@ipc.unicancer.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Soft tissue sarcomas (STS) is generally treated by surgery, followed or preceded by radiotherapy and chemotherapy. Preoperative irradiation has been shown to be effective in a randomized trial, and is often indicated in locally advanced Soft tissue sarcomas of the limbs, in order to reach R0 resection, or in case of rapid tumor growth despite first chemotherapy. For inoperable sarcomas, radiotherapy is an efficient palliative treatment, increasing local control.

Adaptive radiotherapy is defined as the set of procedures leading to the modification of a treatment plan based on the individual variations observed during irradiation. The place of this technique is increasing since the development of image-guided-radiotherapy allowing the visualization of daily variations in position, shape or volume of the tumor and organs at risk. Its implementation in current practice however remains limited because of the cumbersome processes involved (new delineation, new dose calculation, or even re-optimization) and resources to commit, especially in human time.

Irradiation of soft tissue sarcomas always begins with a planning CT scan, where the target-volumes and organ at risk are delineated, and dosimetric calculations are performed prior to radiotherapy initiation. During the radiotherapy, the variations leading to a mismatch between the planned dose and the dose delivered are multiple. These may be due to positioning errors or morphological changes in the patient (weight loss), or in the tumor or organs at risk (modifications in shape, size or position). The volume of soft tissue sarcomas changes also during radiotherapy (response, progression or pseudo- progression of the tumor).

However, to date, few data are available in the literature both on the volume variation of soft tissue sarcomas during preoperative radiotherapy, and on the interest of adaptive radiotherapy in the management of these tumors. It is therefore necessary to evaluate whether modifications of growth or macroscopic tumor volume are observed during the treatment, and to evaluate dosimetric impact on the target volume coverage that could impact the results of the treatment.

This a prospective multicentric phase II trial conducted to evaluate the interest of adaptive radiotherapy in the preoperative or exclusive management of limb sarcomas Patients will be treated by preoperative or definitive radiotherapy for a limb soft tissue sarcomas, using an intensity-modulated conformal irradiation (with a static or dynamic technic), over 5 to 7 consecutive weeks. The total dose delivered will be of 50 Gray (preoperative radiation therapy), or 60 to 70 Gray (exclusive radiation therapy). The delineation of growth or macroscopic tumor volume,clinical target volume, and planning target volume, as well as healthy surrounding tissues will be carried out in each of the centers, and under the responsibility of the radiotherapist, on The simulation CT-scan, used for dosimetry, and 3 CT scan performed on day 1 of radiotherapy (d1), at a dose of 30Gy (d30Gy) and 50Gy (d50GY). The dosimetric re-planning according to the variations of the volume of the planning target volume will be done in case of significant variation of the target volume according to de definition mentionned in the main and secondary objectives.

Main objective: The aim of this study is to evaluate the interest of adaptive radiotherapy in the preoperative or exclusive management of limb sarcomas.

This is the first prospective trial focused on the evaluation of the volume variation of soft tissue sarcomas during preoperative radiotherapy, and also on the interest of adaptive radiotherapy in the management of these tumors, whereas indications of preoperative and/or exclusive radiation therapy are very frequent.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 61
Est. completion date September 20, 2020
Est. primary completion date September 20, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients must have signed the written consent

- Age = 18 years

- Patient with a diagnosis of sarcoma of the limbs (including buttock and shoulder)

- Treatment by preoperative or exclusive radiotherapy (more or less concomitant chemotherapy)

- Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen

Exclusion Criteria:

- Patient with a diagnosis of sarcoma of the head and neck, retroperitoneum, trunk or abdomen

- Person in urgent situation, person of legal age subject to a measure of legal protection (major under guardianship, guardianship or court bail), or unable to express his / her consent

- Impossibility of submitting to the medical examination of the test for geographical, social or psychological reasons.

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Adaptive radiation therapy
Patients will be treated by preoperative or definitive radiotherapy for a limb STS, using an intensity-modulated conformal irradiation (with a static or dynamic technic), over 5 to 7 consecutive weeks. The total dose delivered will be of 50 Gray (preoperative RadioTherapy), or 60 to 70 Gray (exclusive RadioTherapy).

Locations

Country Name City State
France Institut Paoli-Calmettes Marseille Bouches-du-Rhônes

Sponsors (1)

Lead Sponsor Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Variations in growth or macroscopic tumor volume proportion of patients with clinically significant variations in growth or macroscopic tumor volume. Will be considered clinically significant the following variations of more than 10% 3 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03985722 - Olaratumab Plus Trabectedin in Advanced Soft-tissue Sarcoma Patients Soft-tissue Sarcoma Patients Phase 1
Withdrawn NCT02464332 - Safety Study of BLZ-100 in Adult Subjects With Sarcoma Undergoing Surgery Phase 1
Completed NCT00289809 - TLC D-99 and Ifosfamide in Metastatic Soft Tissue Sarcoma Patients Phase 1/Phase 2
Completed NCT00243685 - Chemotherapy Drug Sensitivity Microculture (MiCK) Assay for Apoptosis Phase 2/Phase 3
Active, not recruiting NCT01185964 - A Study of IMC-3G3 in Soft Tissue Sarcoma Phase 1/Phase 2
Completed NCT00753688 - Pazopanib Versus Placebo in Patients With Soft Tissue Sarcoma Whose Disease Has Progressed During or Following Prior Therapy Phase 3
Completed NCT00187174 - Everolimus for Treating Pediatric Patients With Recurrent or Refractory Tumors Phase 1
Completed NCT00093080 - Study of AP23573/MK-8669 (Ridaforolimus), A Mammalian Target of Rapamycin (mTOR) Inhibitor, in Participants With Advanced Sarcoma (MK-8669-018 AM1)(COMPLETED) Phase 2
Completed NCT03798795 - Radiomics for Tumor Grading of Soft Tissue Sarcomas.
Terminated NCT02929394 - Trabectedin Maintenance Post 1st-line in STS Phase 3
Recruiting NCT02275286 - Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients Phase 1/Phase 2
Completed NCT00406601 - BAY-43-9006 in Advanced, Metastatic Soft Tissue Sarcomas Phase 2
Completed NCT00297258 - Pazopanib In Patients With Relapsed Or Refractory Soft Tissue Sarcoma Phase 2
Active, not recruiting NCT06114173 - Efficacy and Safety Study of Cardunilizumab in Soft Tissue Sarcoma Early Phase 1
Completed NCT00061659 - Study Evaluating the Safety and Efficacy of ABT-510 in Subjects With Locally Advanced or Metastatic Soft Tissue Sarcoma Phase 2
Recruiting NCT03815474 - Anlotinib Hydrochloride Combined With Epirubicin and Ifosfamide for Soft Tissue Sarcoma Patients Phase 2
Recruiting NCT02812654 - Ifosfamide, Doxorubicin and Hypofractionated Radiotherapy in Neoadjuvant Sarcoma Treatment Phase 2
Completed NCT00204620 - Bendamustin Hydrochloride in Patients With Soft Tissue Sarcoma (STS) Phase 2
Completed NCT03058406 - A Study on Safety and Efficacy in Patients With Soft Tissue Sarcomas
Active, not recruiting NCT02415816 - Diffusion Weighted Magnetic Resonance in Imaging Younger Patients With Newly Diagnosed Bone or Soft Tissue Sarcomas N/A