Radiotherapy for metastatic spinal cord compression with increased radiation doses (RAMSES-01)

a prospective multicenter study

Dirk Rades, Olfred Hansen, Lars Henrik Jensen, Liesa Dziggel, Christian Staackmann, Claudia Doemer, Jon Cacicedo, Antonio J Conde-Moreno, Barbara Segedin, Raquel Ciervide-Jurio, Carmen Rubio-Rodriguez, Luis A Perez-Romasanta, Ana Alvarez-Gracia, Kristopher Dennis, Carlos Ferrer-Albiach, Arturo Navarro-Martin, Fernando Lopez-Campos, Natalia Jankarashvili, Stefan Janssen, Denise Olbrich & 1 andre Niels Henrik Holländer

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

BACKGROUND: Patients with metastatic spinal cord compression (MSCC) and favorable survival prognoses can benefit from radiation doses greater than 30Gy in 10 fractions in terms of improved local progression-free survival (LPFS) and overall survival (OS).

METHODS/DESIGN: This prospective study mainly investigates LPFS after precision radiotherapy (volumetric modulated arc therapy or stereotactic body radiotherapy) with 18 × 2.33Gy in 3.5 weeks. LPFS is defined as freedom from progression of motor deficits during radiotherapy and an in-field recurrence of MSCC following radiotherapy. The maximum relative dose allowed to the spinal cord is 101.5% of the prescribed dose, resulting in an equivalent dose in 2Gy-fractions (EQD2) for radiation myelopathy is 45.5Gy, which is below the tolerance dose of 50Gy according to the Quantitative Analyses of Normal Tissue Effects in the Clinic (QUANTEC). The EQD2 of this regimen for tumor cell kill is 43.1Gy, which is 33% higher than for 30Gy in 10 fractions (EQD2 = 32.5Gy). Primary endpoint is LPFS at 12 months after radiotherapy. Secondary endpoints include the effect of 18 × 2.33Gy on motor function, ambulatory status, sensory function, sphincter dysfunction, LPFS at other follow-up times, overall survival, pain relief, relief of distress and toxicity. Follow-up visits for all endpoints will be performed directly and at 1, 3, 6, 9 and 12 months after radiotherapy. A total of 65 patients are required for the prospective part of the study. These patients will be compared to a historical control group of at least 235 patients receiving conventional radiotherapy with 10x3Gy in 2 weeks.

DISCUSSION: If precision radiotherapy with 18 × 2.33Gy results in significantly better LPFS than 10x3Gy of conventional radiotherapy, this regimen should be strongly considered for patients with MSCC and favorable survival prognoses.

TRIAL REGISTRATION: Clinicaltrials.gov NCT04043156. Registered 30-07-2019.

OriginalsprogEngelsk
TidsskriftBMC Cancer
Vol/bind19
Udgave nummer1
Sider (fra-til)1163
ISSN1471-2407
DOI
StatusUdgivet - 29. nov. 2019

Fingeraftryk

Multicenter Studies
Prospective Studies
Disease-Free Survival
Intensity-Modulated Radiotherapy
Radiosurgery
Control Groups
Neoplasms

Citer dette

Rades, Dirk ; Hansen, Olfred ; Jensen, Lars Henrik ; Dziggel, Liesa ; Staackmann, Christian ; Doemer, Claudia ; Cacicedo, Jon ; Conde-Moreno, Antonio J ; Segedin, Barbara ; Ciervide-Jurio, Raquel ; Rubio-Rodriguez, Carmen ; Perez-Romasanta, Luis A ; Alvarez-Gracia, Ana ; Dennis, Kristopher ; Ferrer-Albiach, Carlos ; Navarro-Martin, Arturo ; Lopez-Campos, Fernando ; Jankarashvili, Natalia ; Janssen, Stefan ; Olbrich, Denise ; Holländer, Niels Henrik. / Radiotherapy for metastatic spinal cord compression with increased radiation doses (RAMSES-01) : a prospective multicenter study. I: BMC Cancer. 2019 ; Bind 19, Nr. 1. s. 1163.
@article{f8b8307b0945401cb57970c7d0ad1814,
title = "Radiotherapy for metastatic spinal cord compression with increased radiation doses (RAMSES-01): a prospective multicenter study",
abstract = "BACKGROUND: Patients with metastatic spinal cord compression (MSCC) and favorable survival prognoses can benefit from radiation doses greater than 30Gy in 10 fractions in terms of improved local progression-free survival (LPFS) and overall survival (OS).METHODS/DESIGN: This prospective study mainly investigates LPFS after precision radiotherapy (volumetric modulated arc therapy or stereotactic body radiotherapy) with 18 × 2.33Gy in 3.5 weeks. LPFS is defined as freedom from progression of motor deficits during radiotherapy and an in-field recurrence of MSCC following radiotherapy. The maximum relative dose allowed to the spinal cord is 101.5{\%} of the prescribed dose, resulting in an equivalent dose in 2Gy-fractions (EQD2) for radiation myelopathy is 45.5Gy, which is below the tolerance dose of 50Gy according to the Quantitative Analyses of Normal Tissue Effects in the Clinic (QUANTEC). The EQD2 of this regimen for tumor cell kill is 43.1Gy, which is 33{\%} higher than for 30Gy in 10 fractions (EQD2 = 32.5Gy). Primary endpoint is LPFS at 12 months after radiotherapy. Secondary endpoints include the effect of 18 × 2.33Gy on motor function, ambulatory status, sensory function, sphincter dysfunction, LPFS at other follow-up times, overall survival, pain relief, relief of distress and toxicity. Follow-up visits for all endpoints will be performed directly and at 1, 3, 6, 9 and 12 months after radiotherapy. A total of 65 patients are required for the prospective part of the study. These patients will be compared to a historical control group of at least 235 patients receiving conventional radiotherapy with 10x3Gy in 2 weeks.DISCUSSION: If precision radiotherapy with 18 × 2.33Gy results in significantly better LPFS than 10x3Gy of conventional radiotherapy, this regimen should be strongly considered for patients with MSCC and favorable survival prognoses.TRIAL REGISTRATION: Clinicaltrials.gov NCT04043156. Registered 30-07-2019.",
author = "Dirk Rades and Olfred Hansen and Jensen, {Lars Henrik} and Liesa Dziggel and Christian Staackmann and Claudia Doemer and Jon Cacicedo and Conde-Moreno, {Antonio J} and Barbara Segedin and Raquel Ciervide-Jurio and Carmen Rubio-Rodriguez and Perez-Romasanta, {Luis A} and Ana Alvarez-Gracia and Kristopher Dennis and Carlos Ferrer-Albiach and Arturo Navarro-Martin and Fernando Lopez-Campos and Natalia Jankarashvili and Stefan Janssen and Denise Olbrich and Holl{\"a}nder, {Niels Henrik}",
year = "2019",
month = "11",
day = "29",
doi = "10.1186/s12885-019-6390-x",
language = "English",
volume = "19",
pages = "1163",
journal = "B M C Cancer",
issn = "1471-2407",
publisher = "BioMed Central",
number = "1",

}

Rades, D, Hansen, O, Jensen, LH, Dziggel, L, Staackmann, C, Doemer, C, Cacicedo, J, Conde-Moreno, AJ, Segedin, B, Ciervide-Jurio, R, Rubio-Rodriguez, C, Perez-Romasanta, LA, Alvarez-Gracia, A, Dennis, K, Ferrer-Albiach, C, Navarro-Martin, A, Lopez-Campos, F, Jankarashvili, N, Janssen, S, Olbrich, D & Holländer, NH 2019, 'Radiotherapy for metastatic spinal cord compression with increased radiation doses (RAMSES-01): a prospective multicenter study', BMC Cancer, bind 19, nr. 1, s. 1163. https://doi.org/10.1186/s12885-019-6390-x

Radiotherapy for metastatic spinal cord compression with increased radiation doses (RAMSES-01) : a prospective multicenter study. / Rades, Dirk; Hansen, Olfred; Jensen, Lars Henrik; Dziggel, Liesa; Staackmann, Christian; Doemer, Claudia; Cacicedo, Jon; Conde-Moreno, Antonio J; Segedin, Barbara; Ciervide-Jurio, Raquel; Rubio-Rodriguez, Carmen; Perez-Romasanta, Luis A; Alvarez-Gracia, Ana; Dennis, Kristopher; Ferrer-Albiach, Carlos; Navarro-Martin, Arturo; Lopez-Campos, Fernando; Jankarashvili, Natalia; Janssen, Stefan; Olbrich, Denise; Holländer, Niels Henrik.

I: BMC Cancer, Bind 19, Nr. 1, 29.11.2019, s. 1163.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Radiotherapy for metastatic spinal cord compression with increased radiation doses (RAMSES-01)

T2 - a prospective multicenter study

AU - Rades, Dirk

AU - Hansen, Olfred

AU - Jensen, Lars Henrik

AU - Dziggel, Liesa

AU - Staackmann, Christian

AU - Doemer, Claudia

AU - Cacicedo, Jon

AU - Conde-Moreno, Antonio J

AU - Segedin, Barbara

AU - Ciervide-Jurio, Raquel

AU - Rubio-Rodriguez, Carmen

AU - Perez-Romasanta, Luis A

AU - Alvarez-Gracia, Ana

AU - Dennis, Kristopher

AU - Ferrer-Albiach, Carlos

AU - Navarro-Martin, Arturo

AU - Lopez-Campos, Fernando

AU - Jankarashvili, Natalia

AU - Janssen, Stefan

AU - Olbrich, Denise

AU - Holländer, Niels Henrik

PY - 2019/11/29

Y1 - 2019/11/29

N2 - BACKGROUND: Patients with metastatic spinal cord compression (MSCC) and favorable survival prognoses can benefit from radiation doses greater than 30Gy in 10 fractions in terms of improved local progression-free survival (LPFS) and overall survival (OS).METHODS/DESIGN: This prospective study mainly investigates LPFS after precision radiotherapy (volumetric modulated arc therapy or stereotactic body radiotherapy) with 18 × 2.33Gy in 3.5 weeks. LPFS is defined as freedom from progression of motor deficits during radiotherapy and an in-field recurrence of MSCC following radiotherapy. The maximum relative dose allowed to the spinal cord is 101.5% of the prescribed dose, resulting in an equivalent dose in 2Gy-fractions (EQD2) for radiation myelopathy is 45.5Gy, which is below the tolerance dose of 50Gy according to the Quantitative Analyses of Normal Tissue Effects in the Clinic (QUANTEC). The EQD2 of this regimen for tumor cell kill is 43.1Gy, which is 33% higher than for 30Gy in 10 fractions (EQD2 = 32.5Gy). Primary endpoint is LPFS at 12 months after radiotherapy. Secondary endpoints include the effect of 18 × 2.33Gy on motor function, ambulatory status, sensory function, sphincter dysfunction, LPFS at other follow-up times, overall survival, pain relief, relief of distress and toxicity. Follow-up visits for all endpoints will be performed directly and at 1, 3, 6, 9 and 12 months after radiotherapy. A total of 65 patients are required for the prospective part of the study. These patients will be compared to a historical control group of at least 235 patients receiving conventional radiotherapy with 10x3Gy in 2 weeks.DISCUSSION: If precision radiotherapy with 18 × 2.33Gy results in significantly better LPFS than 10x3Gy of conventional radiotherapy, this regimen should be strongly considered for patients with MSCC and favorable survival prognoses.TRIAL REGISTRATION: Clinicaltrials.gov NCT04043156. Registered 30-07-2019.

AB - BACKGROUND: Patients with metastatic spinal cord compression (MSCC) and favorable survival prognoses can benefit from radiation doses greater than 30Gy in 10 fractions in terms of improved local progression-free survival (LPFS) and overall survival (OS).METHODS/DESIGN: This prospective study mainly investigates LPFS after precision radiotherapy (volumetric modulated arc therapy or stereotactic body radiotherapy) with 18 × 2.33Gy in 3.5 weeks. LPFS is defined as freedom from progression of motor deficits during radiotherapy and an in-field recurrence of MSCC following radiotherapy. The maximum relative dose allowed to the spinal cord is 101.5% of the prescribed dose, resulting in an equivalent dose in 2Gy-fractions (EQD2) for radiation myelopathy is 45.5Gy, which is below the tolerance dose of 50Gy according to the Quantitative Analyses of Normal Tissue Effects in the Clinic (QUANTEC). The EQD2 of this regimen for tumor cell kill is 43.1Gy, which is 33% higher than for 30Gy in 10 fractions (EQD2 = 32.5Gy). Primary endpoint is LPFS at 12 months after radiotherapy. Secondary endpoints include the effect of 18 × 2.33Gy on motor function, ambulatory status, sensory function, sphincter dysfunction, LPFS at other follow-up times, overall survival, pain relief, relief of distress and toxicity. Follow-up visits for all endpoints will be performed directly and at 1, 3, 6, 9 and 12 months after radiotherapy. A total of 65 patients are required for the prospective part of the study. These patients will be compared to a historical control group of at least 235 patients receiving conventional radiotherapy with 10x3Gy in 2 weeks.DISCUSSION: If precision radiotherapy with 18 × 2.33Gy results in significantly better LPFS than 10x3Gy of conventional radiotherapy, this regimen should be strongly considered for patients with MSCC and favorable survival prognoses.TRIAL REGISTRATION: Clinicaltrials.gov NCT04043156. Registered 30-07-2019.

U2 - 10.1186/s12885-019-6390-x

DO - 10.1186/s12885-019-6390-x

M3 - Journal article

VL - 19

SP - 1163

JO - B M C Cancer

JF - B M C Cancer

SN - 1471-2407

IS - 1

ER -