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
| ISRCTN | ISRCTN17721852 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17721852 |
| Protocol serial number | N/A |
| Sponsor | Nanobiotix |
| Funder | Nanobiotix |
- Submission date
- 21/12/2016
- Registration date
- 21/02/2017
- Last edited
- 10/04/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Soft Tissue Sarcoma (STS) is a condition in which cancer cells form in the soft tissues of the body, such as the muscles, tendons (bands of tissue that connect muscles to bones), fat and blood vessels. STS most commonly affects tissue in the arms, legs and trunk (torso). In most cases, the first treatment used to treat STS is surgically removing the tumour. This can be done in combination with radiotherapy (using high-energy radiation beams to destroy cancer cells) or chemotherapy (anti-cancer drugs). The aim of this study is to look at the medical records of people who were diagnosed with STS and were treated surgically to see if outcomes are better for those who also had radiotherapy.
Who can participate?
Adults who have been diagnosed with STS between 2008 and 2012
What does the study involve?
Participating centres are asked to prepare a list of patients with STS who were diagnosed between 2008 and 2012. Patients would have been treated with surgery alone, surgery and radiotherapy, surgery and chemotherapy, surgery and chemo-radiation (a combination of radiotherapy and chemotherapy), or surgery and isolated limb perfusion (a type of chemotherapy injected directly into the affected limb) Information from patient charts is then collected in order to find out what treatment the participants had and whether it has been successful.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating.
Where is the study run from?
1. Istituto Oncologico Veneto (Italy)
2. The Royal Marsden NHS Foundation Trust (UK)
3. Állami Egészségügyi Központ - Magyar Honvédség Központi Kórháza (Hungary)
4. Mount Sinai Hospital (Canada)
5. HM Hospitales (Spain)
6. Klinikum der Universität München (Germany)
When is the study starting and how long is it expected to run for?
October 2016 to May 2017
Who is funding the study?
Nanobiotix (France)
Who is the main contact?
Dr Eveline Boucher
eveline.boucher@nanobiotix.com
Contact information
Public
Nanobiotix
60 Rue de Wattignies
Building C
Paris
75012
France
| Phone | +33 40469645 |
|---|---|
| eveline.boucher@nanobiotix.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Retrospective observational cohort chart review |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Multicenter retrospective observational chart review on treatment management of soft tissue sarcoma patients treated by surgery with or without perioperative treatment |
| Study acronym | ROCR |
| Study objectives | The primary objective of this chart review is to investigate the prognostic significance of pathological complete response (pathCR*) to a pre-operative treatment in patients with STS of trunk and extremities on Disease Free Survival (DFS**) at three years. *PathCR is defined as greater than or equal to 95% necrosis/fibrosis or less than or equal to 5% viable cells **DFS is defined as time between diagnosis, and local or distant relapse of the disease or occurrence of any cancer or death |
| Ethics approval(s) | This is a non interventional retrospective review of patient individual charts which does not need ethical approval. In the UK, the Ethics Committee of the Royal Marsden Foundation will review the study. |
| Health condition(s) or problem(s) studied | Malignant soft tissue sarcoma |
| Intervention | 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 manager will be asked to prepare a list of all patients newly diagnosed between 2008 and 2012 with STS. From this list a selection of eligible patients should be performed according to inclusion and exclusion criteria. All data are collected retrospectively. The charts are reviewed once and treatment data are collected in a eCRF. Patients must have been treated between 2008 and 2012 and followed up for 3 years, data of the treatment procedure and the follow up visits are collected at one time point. |
| Intervention type | Other |
| Primary outcome measure(s) |
Disease free survival is measured through medical record review 3 years after disease diagnosis. |
| Key secondary outcome measure(s) |
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 |
| Completion date | 15/05/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 1200 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 13/01/2017 |
| Date of final enrolment | 30/04/2017 |
Locations
Countries of recruitment
- United Kingdom
- England
- Belgium
- Canada
- France
- Germany
- Hungary
- Italy
- Poland
- Spain
Study participating centres
Padova
35128
Italy
Milan
20133
Italy
London
SW3 6JJ
United Kingdom
Budapest
1134
Hungary
00 University Avenue
Toronto
M5G 1X5
Canada
Madrid
28050
Spain
Medizinische Klinik Poliklinik III
Marchioninistr. 15
Munich
81377
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets collected and analysed in this study are available upon reasonable request from: Deloitte Consulting Clémentine Demaire Senior consultant | Health Economics and Outcomes Research Berkenlaan 8a, 1831 Diegem, Belgium Mobile: + 32 470 26 93 76 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/04/2017: Plain English summary added.
