Trial document




drksid header

  DRKS00015816

Trial Description

start of 1:1-Block title

Title

Simultaneous Integrated Protection of Challenging Indications of SBRT

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

SIP CHAI

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Due to the close proximity of the organs, mostly the stomach, the duodenum or the bronchial tree, with the tumor, during stereotactic radiotherapy, a dose reduction is sometimes necessary in order to reduce the risk of toxicities. This might lead to a tumor relapse. In order to avoid a dose reduction to the whole tumor, we defined an extra region which consists of the overlapping parts the organs with the tumor, which receives a lower dose.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The close proximity of organs at risk (OAR), mostly the stomach, the duodenum or the bronchial tree, with the tumor in stereotactic radiotherapy, a dose reduction is required in the entire Planning Target Volume (PTV) during SBRT in order to comply with dose constraints. But a reduction of the dose in the entire PTV hampers local control. In order to avoid a general dose reduction in the PTV, we defined a simultaneous integrated protection volume (SIP) which consists of the overlapping parts the PTV with the PRV (Planning Risk Volume) of an OAR. The dose within the SIP should be as high as possible but still within the constraints for the OARs. In this study we will evaluate the concept of simultaneous integrated protection volume (SIP) regarding toxicity.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00015816
  •   2019/11/13
  •   [---]*
  •   yes
  •   Approved
  •   185/19, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C33 -  Malignant neoplasm of trachea
  •   C34 -  Malignant neoplasm of bronchus and lung
  •   C22 -  Malignant neoplasm of liver and intrahepatic bile ducts
  •   C25 -  Malignant neoplasm of pancreas
  •   C74 -  Malignant neoplasm of adrenal gland
  •   C77 -  Secondary and unspecified malignant neoplasm of lymph nodes
  •   C76 -  Malignant neoplasm of other and ill-defined sites
  •   C79 -  Secondary malignant neoplasm of other and unspecified sites
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   SBRT using a Simultaneous Integrated Protection (SIP)-IMRT technique allowing commonly employed doses to the dominant PTV (PTVdom) either as 5 fractions x 10 Gy or as 8 fractions x 7.5 Gy or as 12 fractions x 5.5 Gy, and reduced doses to the PTVsip, which consists of the overlap between the PTV and the planning risk volume (PRV) of the organ at risk (OAR). The PTVdom is the PTV minus the PTVsip.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Acute (up to 90 days) and late toxicity (project duration: 24 months)

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Response rate (RECIST, PERCIST), Local control rates, Progression-free survival, Overall Survival

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2019/12/01
  •   50
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

1. Before registration, patient's written informed consent has been obtained;
2. Age ≥ 18 years, male and female patients;
3. Legal capacity, patient is able to understand the nature, significance, and consequences of the study;
4. Diagnosis of cancer, confirmed by either histology, cytology, or clinically (imaging and tumour markers);
5. Tumour located close to highly vulnerable organs at risk (OAR): (1) precluding SBRT at doses to a biologically equivalent dose (BED) of <80 Gy (αβ10) prescribed to the Planning target volume (PTV)according to ICRU with standard planning; (2) due to violation of dose constraints for OAR as specified in Table 2 (see Appendices);
6. Tumour location between the plane of the cranial tips of the lungs and the inferior border of the pelvis. All lesions need to be treatable by local curative therapy;
7. 1-3 lesions with at least 1 lesion requiring SIP-IMRT; all diagnosed lesions are treated with a local treatment method; combinations of SBRT and surgery or other local therapies are allowed;
8. WHO performance status ≤ 2;
9. Life expectance ≥ 6 months;
10. Patients of childbearing / reproductive potential should use adequate birth control measures, during the study treatment period. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly;
11. For metachronous lesions patients cannot be registered in this study more than once.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

1. Prior radiotherapy to the region(s) to be treated;
2. Chemotherapy and/or targeted treatment within 2 weeks before the start of SBRT;
3. Presence of infiltration of OARs such as tracheal, oesophageal infiltration or infiltration of small/large bowel or stomach;
4. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the study.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Ms.  Prof. Dr. med.  Anca-L.  Grosu 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Ms.  Dr. med.  Eleni  Gkika 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Ms.  Dr. med.  Eleni  Gkika 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.