Simultaneous Integrated Protection of Challenging Indications of SBRT
Organizational Data
- DRKS-ID:
- DRKS00015816
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2019-11-13
- Last update in DRKS:
- 2023-07-11
- Registration type:
- Prospective
Acronym/abbreviation of the study
SIP CHAI
URL of the study
No Entry
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.
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.
Health condition or problem studied
- ICD10:
- C33 - Malignant neoplasm of trachea
- ICD10:
- C34 - Malignant neoplasm of bronchus and lung
- ICD10:
- C22 - Malignant neoplasm of liver and intrahepatic bile ducts
- ICD10:
- C25 - Malignant neoplasm of pancreas
- ICD10:
- C74 - Malignant neoplasm of adrenal gland
- ICD10:
- C77 - Secondary and unspecified malignant neoplasm of lymph nodes
- ICD10:
- C76 - Malignant neoplasm of other and ill-defined sites
- ICD10:
- C79 - Secondary malignant neoplasm of other and unspecified sites
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- 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.
Endpoints
- Primary outcome:
- Acute (up to 90 days) and late toxicity (project duration: 24 months)
- Secondary outcome:
- Response rate (RECIST, PERCIST), Local control rates, Progression-free survival, Overall Survival
Study Design
- Purpose:
- Treatment
- Allocation:
- N/A (single arm study)
- Control:
-
- Uncontrolled/single arm
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Single (group)
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Universitätsklinik für Strahlentherapie Magdeburg
- Medical center Kliniken Maria Hilf Mönchengladbach
- University medical center Klinik für Strahlenheilkunde Freiburg im Breisgau
Recruitment period and number of participants
- Planned study start date:
- 2019-12-01
- Actual study start date:
- 2020-03-25
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 50
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- 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.
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.
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum Freiburg, Klinik für StrahlenheilkundeProf. Dr. med. Anca-L. GrosuRobert-Koch-Str. 379106 FreiburgGermany
- Telephone:
- 0761 270 94610
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum Freiburg, Klinik für StrahlenheilkundeDr. med. Eleni GkikaRobert-Koch-Str. 379106 FreiburgGermany
- Telephone:
- 0761 270 95200
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Universitätsklinikum Freiburg, Klinik für StrahlenheilkundeDr. med. Eleni GkikaRobert-Koch-Str. 379106 FreiburgGermany
- Telephone:
- 0761 270 95200
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Universitätsklinikum Freiburg, Klinik für StrahlenheilkundeDr. med. Eleni GkikaRobert-Koch-Str. 379106 FreiburgGermany
- Telephone:
- 0761 270 95200
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsklinikum Freiburg, Klinik für StrahlenheilkundeRobert-Koch-Str. 379106 FreiburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Albert-Ludwigs-Universität FreiburgEngelberger Str. 2179106 FreiburgGermany
- Telephone:
- +49-761-27072600
- Fax:
- +49-761-27072630
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2019-06-19
- Ethics committee number:
- 185/19
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2019-10-31
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry