Bone MetastasesSAINTNCT03554135
Single frActIoN eighT Gray Palliative Radiotherapy With Modulated Intensity for Pain Reduction
An observational study of Bone Metastases and Radiotherapy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
Non-randomized, monocentric, observational study to evaluate the response in terms of reduction of painful symptoms from bone metastases to radiotherapy with high personalization of treatment: performed with modern technology, supplied with modulated intensity technique with concomitant integrated boost, according to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastases, Radiotherapy, Technology
- What is being tested?
- Personalization of palliative radiotherapy
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2018to 31 Jul 2019
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Considering the observational nature of the study, all patients corresponding to the "Inclusion Criteria" will be taken into consideration over a period of 6 months from the beginning of the study. 50 patients are expected to be enrolled.
Who may be able to join
- Patients diagnosed with spinal bone metastases from solid, uncomplicated tumor
- Established primary or secondary tumor histology correlated to the treatment lesion
- Age >18 years
- Obtaining informed consent
- Symptomatic patients (NRS> = 4) at the treatment site
- Prognosis <6 months according to Mizumoto Prognostic Score (i.e. Class B or C)
- Spine Instability Neoplastic Score (SINS) <7
Who cannot join
- Concurrent disorders (psychiatric and otherwise) which, in the opinion of the investigator, make data collection unreliable
- Impossibility to assign specific NRS for each CTV to be enrolled
- Previous radiotherapy at the same site or at the level of adjoining metamers (higher or lower than the one to be enrolled)
- Radiometabolic therapy
- Previous enrollment of the same patient for 3 irradiated lesions
- Epidural compression of the spinal cord or of the cauda equina
Show all 9Show fewer
- Injuries affecting> 25% of the medullary canal and / or a distance <5 mm from the medulla or from the cauda
- Injuries with indication of surgical stabilization
- Pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: SAINT: Single frActIoN eighT Gray Palliative Radiotherapy With Modulated Intensity for Pain Reduction: a Single Arm Cohort Analysis
Non-randomized, monocentric, observational study to evaluate the response in terms of reduction of painful symptoms from bone metastases to radiotherapy with high personalization of treatment: performed with modern technology, supplied with modulated intensity technique with concomitant integrated boost, according to selection of patients in accordance with prognosis determined by specific prognostic score
Read the detailed description
Palliative antalgic oncological treatments concern a chronically-evolving disease patient with pain control problems, and are a complex problem from different points of view: logistic, clinical and scientific research. An increasing number of patients are afflicted due to the increased incidence of cancer in all its phases and the potential chronicity of the disease linked to new therapies.
The use of palliative anti-radiation radiotherapy treatments involves up to 40% of patients in a Radiotherapy Center. Radiotherapy was used in the palliative treatment of symptomatic bone metastases to improve quality of life (QoL) of these patients. This is the easiest way to respond to problems of home care or long-term care (eg: Hospice). This need is particularly accentuated for patients with a more severe situation. To reduce the overall duration of the treatment, it is necessary to manage hypofractionated regulators (ie with dose fractionation which daily dispense a dose higher than 2Gy). In fact, hypofractionated regimes concern the gold standard for these clinical presentations.
With the same pain control, multiple fractionation boards report better symptom control over time and are therefore very often preferred for patients with a prognosis> 6 months. On the other hand, the treatment regimen with 8 Gy in single therapy session is suggested as preferable for patients with a worse prognosis (ie less than 6 months of life expectancy). Evidence from literature suggests that palliative radiation therapy is effective in controlling pain even in the last weeks of the patient's life and therefore useful to improve the conditions of patients with a more severe prognosis.
The identification of patients with the worst prognosis to which single-agent radiotherapy is reserved is another crucial aspect. Unfortunately, although clinically validated in scientific trials, the routine use of prognostic scores is rarely used in everyday clinical practice to characterize life expectancy and define the most appropriate treatment regimen. This aspect limits the effective personalization of palliative treatments of this type.
Furthermore, the indications available in the literature do not specify a univocally shared standard of technical approach to radiant treatment. The Consensus Conference whose data have been reported by Chow et al. considers as potentially applicable both non-conformed techniques (e.g .: single back beam) and the most modern conformational techniques. The less conformed techniques have the defect of distributing in a more variable way the dose inside the target to irradiate and to save less well the organs at risk (OAR) with consequent increase of the risk of toxicity that could reduce the beneficial to the patient given by the reduction of pain from metastases.
Finally, the prescription of the single 8 Gy radiotherapy session in daily practice is still not sufficiently widespread, as evidenced by international literature . Due to the peculiar characteristics of the patients who need these treatments, scientific research aimed at optimizing these therapies is a need for assistance and even ethics.
This particular analysis, within the Umbrella Protocol, focuses on patients with uncomplicated and painful vertebral bone metastases, and is aimed at observing and recording the efficacy of treatment in a single 8 Gy session, applied in good clinical practice. according to available evidence.
Particular attention is paid to applying a high degree of personalization of the treatment and a modern approach to the technology of performing the radiant treatment. The personalization of the treatment will be favored by the routine use of: i) a valid prognostic score for the expected survival, the Mizumoto prognostic Score (Mizumoto M, 2008), to identify patients with the worst prognosis to offer treatment in a single session. The use of the most advanced radiation dose administration technologies will be applied by choosing (in the spectrum of technologies applicable to these clinical presentations) the most modern modulated intensity radiotherapy (IMRT). IMRT allows to reduce the dose administered to the OAR and to concentrate the areas with the highest dose concentration (the so-called "hot spots") only within the evidence of disease (or "Gross tumor Volume" - GTV). Through the integrated simultaneous boost (SIB) method in IMRT, it is possible, in fact, to check the extent and location of the "hot zones" by specifying, through precise prescription, the maximum desired amount and the topographic limits to the inside of the target prescribed at the dose of 8 Gy, however doing "drop" the dose to the surrounding OAR.
The hypothesis of the study is to observe the rates of pain control and the need to retract the patient, when applied to personalization of indications and maximum technological support. These results could be a basis of scientific evidence to further support the clinical orientation towards the use of the single fraction of radiotherapy with consequent improvement in the quality of life of these patients. Furthermore, such data will be able to feed further analyzes aimed at the cost / effectiveness of this approach.
- Conditions
- Bone Metastases, Radiotherapy, Technology
- Being tested
- Personalization of palliative radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalization of palliative radiotherapyOther
Observe the rates of pain control and the need to retreat patient, when applied to personalization of indications and maximum technological support for palliative radiotherapy to patients with < 6 months prognostic score attendance
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain control
Pain control measured with Numeric Rating Scale (NRS) score, a 11-point scale for patient self-reporting of pain.
NRS score presents a total range between 0 (no pain) and 10 maximum pain.
NRS subscale are the sequent:
- 0: no pain
- 1-3: mild pain
- 4-6: moderate pain
- 7-10 severe pain
Measured: 1 month after end of radiotherapy
Secondary outcomes (2)
Re-treatment during follow up
Rate of re-treatment during follow up
Measured: 12 months after end of radiotherapy
Pain-dipendent variables
To evaluate the possible correlation between the adequacy of antalgic treatment and potential predictors such as tumor type, purpose of treatment, care setting, stage of disease
Measured: 12 months after end of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start1 Dec 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Cellini, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Francesco Cellini, MD, Principal investigator, Fondazione Policlinico Gemelli IRCCS - Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554135
- Sponsor's protocol ID
- 0011201/18
- Acronym
- SAINT
- Status last verified
- Aug 2018
- First submitted
- 31 May 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Benedict SH, Yenice KM, Followill D, Galvin JM, Hinson W, Kavanagh B, Keall P, Lovelock M, Meeks S, Papiez L, Purdie T, Sadagopan R, Schell MC, Salter B, Schlesinger DJ, Shiu AS, Solberg T, Song DY, Stieber V, Timmerman R, Tome WA, Verellen D, Wang L, Yin FF. Stereotactic body radiation therapy: the report of AAPM Task Group 101. Med Phys. 2010 Aug;37(8):4078-101. doi: 10.1118/1.3438081.
PubMed 20879569Bentzen SM, Constine LS, Deasy JO, Eisbruch A, Jackson A, Marks LB, Ten Haken RK, Yorke ED. Quantitative Analyses of Normal Tissue Effects in the Clinic (QUANTEC): an introduction to the scientific issues. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3 Suppl):S3-9. doi: 10.1016/j.ijrobp.2009.09.040.
PubMed 20171515Braam P, Lambin P, Bussink J. Stereotactic versus conventional radiotherapy for pain reduction and quality of life in spinal metastases: study protocol for a randomized controlled trial. Trials. 2016 Feb 2;17:61. doi: 10.1186/s13063-016-1178-7.
PubMed 26829933Chow E, Hoskin P, Mitera G, Zeng L, Lutz S, Roos D, Hahn C, van der Linden Y, Hartsell W, Kumar E; International Bone Metastases Consensus Working Party. Update of the international consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):1730-7. doi: 10.1016/j.ijrobp.2011.02.008. Epub 2011 Apr 12.
PubMed 21489705Correa RJ, Salama JK, Milano MT, Palma DA. Stereotactic Body Radiotherapy for Oligometastasis: Opportunities for Biology to Guide Clinical Management. Cancer J. 2016 Jul-Aug;22(4):247-56. doi: 10.1097/PPO.0000000000000202.
PubMed 27441744Deodato F, Cilla S, Macchia G, Torre G, Caravatta L, Mariano G, Mignogna S, Ferro M, Mattiucci GC, Balducci M, Frascino V, Piermattei A, Ferrandina G, Valentini V, Morganti AG. Stereotactic radiosurgery (SRS) with volumetric modulated arc therapy (VMAT): interim results of a multi-arm phase I trial (DESTROY-2). Clin Oncol (R Coll Radiol). 2014 Dec;26(12):748-56. doi: 10.1016/j.clon.2014.08.005. Epub 2014 Aug 29.
PubMed 25175042Furfari A, Wan BA, Ding K, Wong A, Zhu L, Bezjak A, Wong R, Wilson CF, DeAngelis C, Azad A, Chow E, Charames GS. Genetic biomarkers associated with pain flare and dexamethasone response following palliative radiotherapy in patients with painful bone metastases. Ann Palliat Med. 2017 Dec;6(Suppl 2):S240-S247. doi: 10.21037/apm.2017.09.04. Epub 2017 Sep 20.
PubMed 29156912Guckenberger M, Hawkins M, Flentje M, Sweeney RA. Fractionated radiosurgery for painful spinal metastases: DOSIS - a phase II trial. BMC Cancer. 2012 Nov 19;12:530. doi: 10.1186/1471-2407-12-530.
PubMed 23164174Mizumoto M, Harada H, Asakura H, Hashimoto T, Furutani K, Hashii H, Takagi T, Katagiri H, Takahashi M, Nishimura T. Prognostic factors and a scoring system for survival after radiotherapy for metastases to the spinal column: a review of 544 patients at Shizuoka Cancer Center Hospital. Cancer. 2008 Nov 15;113(10):2816-22. doi: 10.1002/cncr.23888.
PubMed 18846565Murai T, Murata R, Manabe Y, Sugie C, Tamura T, Ito H, Miyoshi Y, Shibamoto Y. Intensity modulated stereotactic body radiation therapy for single or multiple vertebral metastases with spinal cord compression. Pract Radiat Oncol. 2014 Nov-Dec;4(6):e231-7. doi: 10.1016/j.prro.2014.02.005. Epub 2014 Mar 31.
PubMed 25407874Ryu S, Pugh SL, Gerszten PC, Yin FF, Timmerman RD, Hitchcock YJ, Movsas B, Kanner AA, Berk LB, Followill DS, Kachnic LA. RTOG 0631 phase 2/3 study of image guided stereotactic radiosurgery for localized (1-3) spine metastases: phase 2 results. Pract Radiat Oncol. 2014 Mar-Apr;4(2):76-81. doi: 10.1016/j.prro.2013.05.001. Epub 2013 Jun 4.
PubMed 24890347van der Velden JM, Verkooijen HM, Seravalli E, Hes J, Gerlich AS, Kasperts N, Eppinga WS, Verlaan JJ, van Vulpen M. Comparing conVEntional RadioTherapy with stereotactIC body radiotherapy in patients with spinAL metastases: study protocol for an randomized controlled trial following the cohort multiple randomized controlled trial design. BMC Cancer. 2016 Nov 21;16(1):909. doi: 10.1186/s12885-016-2947-0.
PubMed 27871280
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAINT: Single frActIoN eighT Gray Palliative Radiotherapy With Modulated Intensity for Pain Reduction: a Single Arm Cohort Analysis
- ClinicalTrials.gov ID
- NCT03554135
- Acronym / sponsor ID
- SAINT / 0011201/18
- Conditions
- Bone Metastases, Radiotherapy, Technology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Jul 2019 (estimated)
- First posted
- 12 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-randomized, monocentric, observational study to evaluate the response in terms of reduction of painful symptoms from bone metastases to radiotherapy with high personalization of treatment: performed with modern technology, supplied with modulated intensity technique with concomitant integrated boost, according to selection of patients in accordance with prognosis determined by specific prognostic score
Detailed description
Palliative antalgic oncological treatments concern a chronically-evolving disease patient with pain control problems, and are a complex problem from different points of view: logistic, clinical and scientific research. An increasing number of patients are afflicted due to the increased incidence of cancer in all its phases and the potential chronicity of the disease linked to new therapies.
The use of palliative anti-radiation radiotherapy treatments involves up to 40% of patients in a Radiotherapy Center. Radiotherapy was used in the palliative treatment of symptomatic bone metastases to improve quality of life (QoL) of these patients. This is the easiest way to respond to problems of home care or long-term care (eg: Hospice). This need is particularly accentuated for patients with a more severe situation. To reduce the overall duration of the treatment, it is necessary to manage hypofractionated regulators (ie with dose fractionation which daily dispense a dose higher than 2Gy). In fact, hypofractionated regimes concern the gold standard for these clinical presentations.
With the same pain control, multiple fractionation boards report better symptom control over time and are therefore very often preferred for patients with a prognosis> 6 months. On the other hand, the treatment regimen with 8 Gy in single therapy session is suggested as preferable for patients with a worse prognosis (ie less than 6 months of life expectancy). Evidence from literature suggests that palliative radiation therapy is effective in controlling pain even in the last weeks of the patient's life and therefore useful to improve the conditions of patients with a more severe prognosis.
The identification of patients with the worst prognosis to which single-agent radiotherapy is reserved is another crucial aspect. Unfortunately, although clinically validated in scientific trials, the routine use of prognostic scores is rarely used in everyday clinical practice to characterize life expectancy and define the most appropriate treatment regimen. This aspect limits the effective personalization of palliative treatments of this type.
Furthermore, the indications available in the literature do not specify a univocally shared standard of technical approach to radiant treatment. The Consensus Conference whose data have been reported by Chow et al. considers as potentially applicable both non-conformed techniques (e.g .: single back beam) and the most modern conformational techniques. The less conformed techniques have the defect of distributing in a more variable way the dose inside the target to irradiate and to save less well the organs at risk (OAR) with consequent increase of the risk of toxicity that could reduce the beneficial to the patient given by the reduction of pain from metastases.
Finally, the prescription of the single 8 Gy radiotherapy session in daily practice is still not sufficiently widespread, as evidenced by international literature . Due to the peculiar characteristics of the patients who need these treatments, scientific research aimed at optimizing these therapies is a need for assistance and even ethics.
This particular analysis, within the Umbrella Protocol, focuses on patients with uncomplicated and painful vertebral bone metastases, and is aimed at observing and recording the efficacy of treatment in a single 8 Gy session, applied in good clinical practice. according to available evidence.
Particular attention is paid to applying a high degree of personalization of the treatment and a modern approach to the technology of performing the radiant treatment. The personalization of the treatment will be favored by the routine use of: i) a valid prognostic score for the expected survival, the Mizumoto prognostic Score (Mizumoto M, 2008), to identify patients with the worst prognosis to offer treatment in a single session. The use of the most advanced radiation dose administration technologies will be applied by choosing (in the spectrum of technologies applicable to these clinical presentations) the most modern modulated intensity radiotherapy (IMRT). IMRT allows to reduce the dose administered to the OAR and to concentrate the areas with the highest dose concentration (the so-called "hot spots") only within the evidence of disease (or "Gross tumor Volume" - GTV). Through the integrated simultaneous boost (SIB) method in IMRT, it is possible, in fact, to check the extent and location of the "hot zones" by specifying, through precise prescription, the maximum desired amount and the topographic limits to the inside of the target prescribed at the dose of 8 Gy, however doing "drop" the dose to the surrounding OAR.
The hypothesis of the study is to observe the rates of pain control and the need to retract the patient, when applied to personalization of indications and maximum technological support. These results could be a basis of scientific evidence to further support the clinical orientation towards the use of the single fraction of radiotherapy with consequent improvement in the quality of life of these patients. Furthermore, such data will be able to feed further analyzes aimed at the cost / effectiveness of this approach.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Considering the observational nature of the study, all patients corresponding to the "Inclusion Criteria" will be taken into consideration over a period of 6 months from the beginning of the study. 50 patients are expected to be enrolled.
Key inclusion criteria (7 listed)
- Patients diagnosed with spinal bone metastases from solid, uncomplicated tumor
- Established primary or secondary tumor histology correlated to the treatment lesion
- Age >18 years
- Obtaining informed consent
- Symptomatic patients (NRS> = 4) at the treatment site
Key exclusion criteria (9 listed)
- Concurrent disorders (psychiatric and otherwise) which, in the opinion of the investigator, make data collection unreliable
- Impossibility to assign specific NRS for each CTV to be enrolled
- Previous radiotherapy at the same site or at the level of adjoining metamers (higher or lower than the one to be enrolled)
- Radiometabolic therapy
- Previous enrollment of the same patient for 3 irradiated lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalization of palliative radiotherapyObserve the rates of pain control and the need to retreat patient, when applied to personalization of indications and maximum technological support for palliative radiotherapy to patients with < 6 months prognostic score attendance | Other | – |
Primary outcome
Pain control
Time frame: 1 month after end of radiotherapy
Pain control measured with Numeric Rating Scale (NRS) score, a 11-point scale for patient self-reporting of pain. NRS score presents a total range between 0 (no pain) and 10 maximum pain. NRS subscale are the sequent: * 0: no pain * 1-3: mild pain * 4-6: moderate pain * 7-10 severe pain
2 secondary outcomes
Re-treatment during follow up
Time frame: 12 months after end of radiotherapy
Pain-dipendent variables
Time frame: 12 months after end of radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Results publication: PubMed 20879569Benedict SH, Yenice KM, Followill D, Galvin JM, Hinson W, Kavanagh B, Keall P, Lovelock M, Meeks S, Papiez L, Purdie T, Sadagopan R, Schell MC, Salter B, Schlesinger DJ, Shiu AS, Solberg T, Song DY, Stieber V, Timmerman R, Tome WA, Verellen D, Wang L, Yin FF. Stereotactic body radiation therapy: the report of AAPM Task Group 101. Med Phys. 2010 Aug;37(8):4078-101. doi: 10.1118/1.3438081.
- Results publication: PubMed 20171515Bentzen SM, Constine LS, Deasy JO, Eisbruch A, Jackson A, Marks LB, Ten Haken RK, Yorke ED. Quantitative Analyses of Normal Tissue Effects in the Clinic (QUANTEC): an introduction to the scientific issues. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3 Suppl):S3-9. doi: 10.1016/j.ijrobp.2009.09.040.
- Results publication: PubMed 26829933Braam P, Lambin P, Bussink J. Stereotactic versus conventional radiotherapy for pain reduction and quality of life in spinal metastases: study protocol for a randomized controlled trial. Trials. 2016 Feb 2;17:61. doi: 10.1186/s13063-016-1178-7.
- Results publication: PubMed 21489705Chow E, Hoskin P, Mitera G, Zeng L, Lutz S, Roos D, Hahn C, van der Linden Y, Hartsell W, Kumar E; International Bone Metastases Consensus Working Party. Update of the international consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):1730-7. doi: 10.1016/j.ijrobp.2011.02.008. Epub 2011 Apr 12.
- Results publication: PubMed 27441744Correa RJ, Salama JK, Milano MT, Palma DA. Stereotactic Body Radiotherapy for Oligometastasis: Opportunities for Biology to Guide Clinical Management. Cancer J. 2016 Jul-Aug;22(4):247-56. doi: 10.1097/PPO.0000000000000202.
- Results publication: PubMed 25175042Deodato F, Cilla S, Macchia G, Torre G, Caravatta L, Mariano G, Mignogna S, Ferro M, Mattiucci GC, Balducci M, Frascino V, Piermattei A, Ferrandina G, Valentini V, Morganti AG. Stereotactic radiosurgery (SRS) with volumetric modulated arc therapy (VMAT): interim results of a multi-arm phase I trial (DESTROY-2). Clin Oncol (R Coll Radiol). 2014 Dec;26(12):748-56. doi: 10.1016/j.clon.2014.08.005. Epub 2014 Aug 29.
- Results publication: PubMed 29156912Furfari A, Wan BA, Ding K, Wong A, Zhu L, Bezjak A, Wong R, Wilson CF, DeAngelis C, Azad A, Chow E, Charames GS. Genetic biomarkers associated with pain flare and dexamethasone response following palliative radiotherapy in patients with painful bone metastases. Ann Palliat Med. 2017 Dec;6(Suppl 2):S240-S247. doi: 10.21037/apm.2017.09.04. Epub 2017 Sep 20.
- Results publication: PubMed 23164174Guckenberger M, Hawkins M, Flentje M, Sweeney RA. Fractionated radiosurgery for painful spinal metastases: DOSIS - a phase II trial. BMC Cancer. 2012 Nov 19;12:530. doi: 10.1186/1471-2407-12-530.
- Results publication: PubMed 18846565Mizumoto M, Harada H, Asakura H, Hashimoto T, Furutani K, Hashii H, Takagi T, Katagiri H, Takahashi M, Nishimura T. Prognostic factors and a scoring system for survival after radiotherapy for metastases to the spinal column: a review of 544 patients at Shizuoka Cancer Center Hospital. Cancer. 2008 Nov 15;113(10):2816-22. doi: 10.1002/cncr.23888.
- Results publication: PubMed 25407874Murai T, Murata R, Manabe Y, Sugie C, Tamura T, Ito H, Miyoshi Y, Shibamoto Y. Intensity modulated stereotactic body radiation therapy for single or multiple vertebral metastases with spinal cord compression. Pract Radiat Oncol. 2014 Nov-Dec;4(6):e231-7. doi: 10.1016/j.prro.2014.02.005. Epub 2014 Mar 31.
- Results publication: PubMed 24890347Ryu S, Pugh SL, Gerszten PC, Yin FF, Timmerman RD, Hitchcock YJ, Movsas B, Kanner AA, Berk LB, Followill DS, Kachnic LA. RTOG 0631 phase 2/3 study of image guided stereotactic radiosurgery for localized (1-3) spine metastases: phase 2 results. Pract Radiat Oncol. 2014 Mar-Apr;4(2):76-81. doi: 10.1016/j.prro.2013.05.001. Epub 2013 Jun 4.
- Results publication: PubMed 27871280van der Velden JM, Verkooijen HM, Seravalli E, Hes J, Gerlich AS, Kasperts N, Eppinga WS, Verlaan JJ, van Vulpen M. Comparing conVEntional RadioTherapy with stereotactIC body radiotherapy in patients with spinAL metastases: study protocol for an randomized controlled trial following the cohort multiple randomized controlled trial design. BMC Cancer. 2016 Nov 21;16(1):909. doi: 10.1186/s12885-016-2947-0.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Cellini, MD principal investigator
Fondazione Policlinico Gemelli IRCCS - Roma
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Metastases and Radiotherapy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Cellini, MD (+39 0630155339, francesco.cellini@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain control (time frame: 1 month after end of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03554135, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.