Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02775799 |
| Other study ID # |
2014-0394 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 2015 |
| Est. completion date |
July 2018 |
Study information
| Verified date |
September 2018 |
| Source |
Balgrist University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Registration of all sarcoma patients treated at a specialized sarcoma center in Switzerland.
Description:
SCIENTIFIC BACKGROUND OF STUDY, EXPECTED OUTCOME, AND RELEVANCE Sarcomas represent malignant
bone and soft tissue tumours. Overall, these are very rare tumours representing less than 1%
of all cancers (besides carcinomas and haematological cancers). Furthermore, with the advent
of molecular knowledge, more than 100 subtypes of sarcomas can be distinguished and many of
them share a distinct biological behaviour opening the possibility of targeted therapy. The
management of patients with sarcomas is extremely complex and highly multidisciplinary,
involving the pathologist, the orthopaedic oncologist, a paediatric and medical oncologist,
the radiation oncologist, the reconstructive as well as visceral and chest surgeon. Surgery
remains the mainstay of treatment, but almost always in combination with either radiotherapy
or chemotherapy, or novel targeted therapy. The key of successful therapy (and consequent
successful outcome for the patient) remains the orchestrated team approach among these
disciplines where the therapeutic strategy is interdisciplinary determined at the sarcoma
board. Unfortunately, all too often and still nowadays, patients also in Switzerland are not
treated within such a network. E.g., too many surgeons still believe that they are capable to
remove a soft tissue lump (which technically is true), just to send the patient off after
surgery to the medical oncologist, and never see the patient again. All too often this may
result for example in an unnecessary amputation, a devastating consequence for the patient. A
surgeon needs to be aware of the interpretation of the pathologic specimen, the possibilities
of adjuvant treatment, and most importantly, the biology of each subtype of sarcoma, before
embarking on surgery. Because of all the reasons listed above, it is very reasonable to
centralize the treatment of sarcoma patients to improve the treatment and outcome for sarcoma
patients in Switzerland, as is foreseen by the current initiative of HSM by the GDK. It is
very important to state that such uncoordinated treatment of sarcoma patients with the
potential deleterious consequences is an international phenomenon. Many groups have
independently established that the lack of interdisciplinarity leads to worse patient outcome
and survival. Many reasons account for this: rarity of disease, lack of knowledge, lack of
awareness, and all too often also pride and prestige. The only way out is to bring treating
physicians together and to make the institutions aware that applying simple management
strategies -such as coordinated treatment- does improve the outcome of sarcoma patients,
which has been proven in many countries already. Nowadays in Switzerland, there are only very
few groups/institutions who deal exclusively with sarcoma patients. Consequently, the
therapeutic approach and quality are varying a lot. Therefore, the establishment of a Swiss
Sarcoma Cohort Study (SwissSARCOS) is instrumental in improving the quality of treatment,
which has already been shown in other countries. If all patients are registered including
their respective follow-up, the type of treatment can be registered and the various
geographic regions can be compared with respect to patients` outcome. It can be expected that
the awareness of treating a sarcoma patient according to international standards will be
increased, for the benefit of the patient. Importantly, such registration will provide the
base to participate in international studies in form of clinical trials, which is a
prerequisite and also requested by the HSM, and will further improve the quality of the
therapy of sarcoma patients in Switzerland. Such cohort study will also allow to assess the
prevalence of sarcoma types in Switzerland, with its associated regional differences. Because
of its rarity, registering all sarcoma types in Switzerland will bring together sizeable
numbers and therefore will provide the base for numerous outcome studies. Because it is known
that sarcomas are extremely heterogeneous and are molecularly defined, studying molecular
alterations in tumour tissue is essential to advance the field. The French Sarcoma Group
(Prof. JM.Coindre, F.Chibon) has started such initiative decades ago and are therefore
leaders in this field. The investigators therefore speculate that SwissSARCOS ultimately will
also provide a strong base to establish a sarcoma tissue bank which allows the study of
molecular alterations on the one hand, but on the other hand to correlate these findings with
clinical outcome. For these reasons outlined above, the establishment of SwissSARCOS is
crucial to improve treatment quality of sarcoma patients in Switzerland.
The specific questions addressed within the first 2-year time period include: 1.) what is the
prevalence of which sarcoma type in Switzerland; 2.) What is the quality of the (correct)
diagnosis?; 3.) What is the quality of treatment?; 4.) What is the outcome (survival, local
recurrence, metastasis etc.) of sarcoma patients in Switzerland? Complete identification and
thorough assessment of the basic clinical parameters ("minimal data set") of sarcoma patients
treated in Switzerland in a prospective manner will allow to improve the quality of patient
care as outlined above. This is also in line with the national strategy to register all
cancer patients. Therefore, this effort is very timely and has direct impact on public health
issues. As shown for other cohort studies in Switzerland (e.g. HIV), such assessment of
clinical parameters has widespread implications not only on the standard of patient care, but
also on addressing important clinical research questions, thereby becoming a very relevant
health care issue. Through such coordinated and orchestrated approach, Switzerland will
become a key player for international collaborations to improve the treatment for sarcoma
patients. It is very clear that it cannot be expected to include every single patient
diagnosed with sarcoma of whole Switzerland right from the beginning. Obviously, it is the
intention to first set a strong base with national key players and institutions, and then to
strengthen this collaborative network to become a national instrument. The network of
national key players and institutions should allow to bring all the regional efforts to a
national level. The Sarcoma Center Zurich (www.sarkomzentrum.ch) is certified as a center of
excellence by the German Cancer Society (DKG= Deutsche Krebsgesellschaft) since December
2013, the very first one in Switzerland. The Sarcoma Center in Zurich bases on the
instrumental efforts of the cantonal government ("Regierungsrat") to specifically support the
multidisciplinary team approach in musculoskeletal oncology, both on the clinical and
research side since 2010 by the HSM program (www.sarkomboard.ch). Over the years,
collaboration with all major regional hospitals in Switzerland was set up. All the
collaborators of these hospitals have assembled to strengthen the goal to build up a Sarcoma
Cohort Study. For that reasons the Sarcoma Center Zurich has the lead for this multicentre
study and the ethic committee of Zurich is chosen as the leading committee.
Future: Molecular analyses of sarcoma tissue are the key for the advancement of the treatment
strategies of sarcoma patients. Again based on the HSM program funded by the cantonal
government in Zurich, tumour tissue specimens as well as blood is collected and stored of
each single patient operated for a sarcoma in Zurich. This allows addressing fundamental
molecular questions via TMA (tissue microarray analyses), the characterization of molecular
markers, both in-vitro and in-vivo, proteomic diagnostic analyses, and novel targeted
treatment approaches (please refer to www.sarkomzentrum.ch). It is foreseen that in the
second phase of this grant project -and after having established the fundamentals of the
national cohort study- to extend the efforts to not only gather patient data ("minimal data
set"), but also tumour tissue/blood from the sarcoma patients treated in Switzerland.
In a further next step, and again based on these efforts outlined above with a nationally
well documented patient cohort, the base will be set to participate in international clinical
trials to test for example novel drug compounds or novel diagnostic imaging tools.
