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Precision Radiotherapy for Metastases to the Lung.


- candidate number5676
- NTR NumberNTR1788
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-apr-2009
- Secondary IDs2008-292 / 23450 / NL23450.078.08 METC ErasmusMC / ABR number / file number
- Public TitlePrecision Radiotherapy for Metastases to the Lung.
- Scientific TitleStereotactic Radiotherapy for Metastases to the Lung.
- ACRONYMLUMERAS
- hypothesisRadiotherapy involving a high biological dose with a limited treatment volume achieves a local tumor control rate of at least 90% in patients with metastatic cancer to the lung.
- Healt Condition(s) or Problem(s) studiedMetastasis, Lung, Oligometastases
- Inclusion criteria1. Minimal life expectancy of 6 months;
2. WHO 0-3;
3. Metastatic disease limited to a maximum of 2 organs;
4. No more than 5 metastatic lesions and a controlled primary tumor site;
5. Diagnostic imaging includes at least a PET-scan and CT ¨Cthorax/abdomen, of which one is not older than 4 weeks at the time of referral for SBRT;
6. Primary tumor must be treated at least 4 months before the diagnosis of the metastasis;
7. Patients are discussed in a multidisciplinary team, including a pulmonologist and/or medical oncologist;
8. Patients with more than 2 lung metastases should be treated with a first line chemotherapeutical agent prior to stereotactic radiotherapy in all cases unless the patient is not suitable for chemotherapy;
9. Patients must be 18 years or older;
10. Woman with pregnancy potential must use an effective contraceptive method;
11. Patients must sign a study-specific consent form;
12. FEV1 > 40% of predicted;
13. Leukocytes > 3 x 109;
14. Thrombocytes > 100 x 109;
15. Bilirubine < 1.5 mg/dl;
16. PTT > 60%.
- Exclusion criteria1. Pregnant women;
2. Inability to lie flat for at least 90 minutes.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mrt-2009
- planned closingdate1-mrt-2014
- Target number of participants30
- InterventionsPatients are treated with 1-7 fractions of stereotactic radiotherapy using the CyberKnife. The treatment schedule will depend on the tumor location and size.
1. Peripheral tumors >3cm: 3 fractions of 20 Gy (60Gy).
2. Peripheral tumors <3cm: Single dose of 30 Gy (30Gy).
3. Central tumors: 5 fractions of 12 Gy (60Gy).
4. Mediastinal tumors: 7 fractions of 8 Gy (56Gy).

Prior to treatment with the CyberKnife, markers will be placed into/or near the tumor in order to enable "tumor tracking". This enables the CyberKnife to precisely deliver a high radiation dose.
Markers are placed using one of the following approaches: via bronchoscopy, vascular placement (catheterization), or intra- or extra-pulmonary marker placement.

No control group
- Primary outcomeLocal tumor control rate at 1 year.
Sample size was calculated with P0=70%, P1=90%, and alpha/beta =0.10.
1. P0= largest probability of Local Tumor Control that implies that therapeutic activity is too low and does not warrant further investigation;
2. P1= smallest probability of Local Tumor Control that implies that therapeutic activity is sufficient to warrant further investigation.
- Secondary outcome1. Overall surival (at one and two years);
2. Progression-free survival (at one and two years);
3. Treatment related toxicity (acute at 6 months; Late at 2 years).
- TimepointsTimepoints of primary and secondary outcomes: See above.

Follow up:
Pulmonary function tests and CT-scans will be done four times during the first year, twice during the second year, and once during the third year of follow-up.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. N.C. Voort van Zyp, van der
- CONTACT for SCIENTIFIC QUERIESMD. PhD. J.J. Nuyttens
- Sponsor/Initiator Erasmus Medical Center, Daniel den Hoed Cancer Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Daniel den Hoed Cancer Center
- PublicationsNo publications related directly to the LUMERAS study.

Publications related to CyberKnife treatment (for primary non-small cell lung cancer) at the Erasmus MC-Daniel den Hoed Cancer Center, Rotterdam, The Netherlands:
van der Voort van Zyp NC, Prevost JB, Hoogeman MS, Praag J, van der Holt B, Levendag PC, van Klaveren RJ, Pattynama P, Nuyttens JJ. "Stereotactic radiotherapy with real-time tumor tracking for non-small cell lung cancer: Clinical outcome." Radiother Oncol. 2009 Mar 16. PMID: 19297048
Nuyttens JJ, Prevost JB, Praag J, Hoogeman M, Van Klaveren RJ, Levendag PC, Pattynama PM. "Lung tumor tracking during stereotactic radiotherapy treatment with the CyberKnife: Marker placement and early results." Acta Oncol. 2006;45(7):961-5. PMID: 16982564
Prevost JB, Nuyttens JJ, Hoogeman MS, Pöll JJ, van Dijk LC, Pattynama PM. Endovascular coils as lung tumour markers in real-time tumour tracking stereotactic radiotherapy: preliminary results." Eur Radiol. 2008 Aug;18(8):1569-76. Epub 2008 Apr 4. PMID: 18389249
- Brief summaryObjective:
To determine whether stereotactic radiotherapy achieves a local tumor control rate comparable to surgery (i.e. 90%) in patients with metastatic disease.
Study design:
Non-randomized, single center prospective phase II trial.
Study population:
Patients with limited metastatic lung disease who are inoperable or refuse surgery. Inclusion criteria include: a minimal life expectancy of 6 months, metastatic disease to maximum 2 organs, <5 metastatic lesions, and an interval between treatment of the primary tumor and diagnosis of the metastases of minimal 4 months.
Intervention:
1-7 fractions of stereotactic radiotherapy depending on tumor size and location. Placement of markers into/near the tumor prior to radiation therapy.
Primary outcome:
Local tumor control at one year.
Secondary outcome:
Overall and progression-free survival and treatment-related toxicity.
- Main changes (audit trail)
- RECORD29-apr-2009 - 23-sep-2009


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