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Retrospective study in patient with soft tissue sarcoma of trunk wall and extremities who have been treated with surgery in association or not with chemotherapy and/or radiotherapy, to point out the response to preoperative treatment and outcome

Multicenter retrospective observational chart review on treatment management of soft tissue sarcoma patients treated by surgery with or without perioperative treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN17721852
Enrollment
1200
Registered
2017-02-21
Start date
2017-01-13
Completion date
Unknown
Last updated
2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant soft tissue sarcoma Cancer Sarcoma

Interventions

Each center will be asked to prepare a list of eligible patients based on inclusion and exclusion criteria. If no database of soft tissue sarcoma (STS) patients is available, the institution data mana

Sponsors

Nanobiotix
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Primary Soft Tissue Sarcoma (STS) of the extremities and trunk wall newly pathologically diagnosed between 2008 and 2012 with STS. 2. Age = 18 years old 3. Any histology (except those specified in exclusion criteria below) 4. Any grade 5. Treated by any of these therapies for the primary tumor: 5.1. Surgery alone 5.2. Surgery + radiation therapy (pre, post or per-operative) 5.3. Surgery + chemotherapy (pre or post-operative) 5.4. Surgery + chemo-radiation (pre or post-operative) 5.5. ILP (isolated limb perfusion) and surgery +/- radiation therapy

Exclusion criteria

Exclusion criteria: 1. Patients with the following histological type: bone sarcoma, Kaposi's sarcoma, primitive neuroectodermal tumor, angiosarcoma, epithelioid hemangioendothelioma 2. Benign or intermediate histological subtypes: aggressive fibromatosis, desmoid tumor or dermatofibrosarcoma protuberans 3. Gastrointestinal stromal tumour (GIST) 4. STS localized in the intra-abdominal region and retroperitoneal region 5. Re-resection for non carcinological first resection (R1 or R2) 6. Patient with metastatic disease at diagnosis of STS 7. No pathological report available at diagnosis or at surgery 8. Less than 36 months (pilot and extended phase) of data available following diagnosis unless the patient died before 9. No possibility to have access to the data 10. Concurrent active therapy for another cancer (= patient receives active treatment for this cancer during the study period)

Design outcomes

Primary

MeasureTime frame
Disease free survival is measured through medical record review 3 years after disease diagnosis.

Secondary

MeasureTime frame
1. Pathological response (% of necrosis, % of fibrosis, % of viable cells) is measured through review of the pathological report of the surgical specimen at the time of surgery 2. Tumor type and subtype is assessed through pathological report review at diagnosis and the time of surgery 3. Chemotherapy treatment (drug name, drug dose, treatment duration, number of cycles) is assessed by reviewing drug prescription form at each course of chemotherapy and at the end of chemotherapy treatment 4. Radiation treatment (Dose delivered, treatment duration) is assessed by reviewing medical radiation report at the end of Radiation treatment 5. Surgical procedure (conservative surgery, amputation, R0 resection, R2 resection) is assessed by reviewing the medical surgery report at the time of surgery 6. Quality of surgery (R0 resection, R1 resection, surgical margin, tumor size) is measured by reviewing pathological reports at the date of surgery 7. New tumors (local recurrence, distant recurrence, other cancer) are assessed by reviewing medical report and radiological MRI and CT scan report on the date of surgery, 6 months after surgery, 12 months after surgery, 18 months after surgery, 24 months after surgery, 30 months after surgery, 36 months after surgery 8. Quality of life (Performans status, walking distance, presence at work) is measured by reviewing medical reports on the date of diagnosis of the tumor, date of surgery, 6 months after surgery, 12 months after surgery, 18 months after surgery, 24 months after surgery, 30 months after surgery, 36 months after surgery

Countries

Belgium, Canada, France, Germany, Hungary, Italy, Poland, Spain, United Kingdom

Contacts

Public ContactEveline Boucher
eveline.boucher@nanobiotix.com+33 40469645

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026