Radiotherapy of Motor Deficits From Metastatic Epidural Spinal Cord Compression

NCT02189473 | Completed Results DMC

• 1 other identifier: ARO 200901
• Study Type: interventional
• Target: 203
• Locations: 6 countries
• Sites: 15

Brief Summary

The primary aim of this randomized multi-center trial is to investigate the efficacy of the radiotherapy regimens 5 x 4 Gy and 10 x 3 Gy with respect to the effect on motor function in patients with metastatic epidural spinal cord compression.

Conditions

Metastatic Epidural Spinal Cord Compression

Keywords

metastatic epidural spinal cord compression; motor function; ambulatory status; pain; quality of life; overall survival; local control; toxicity

Outcome Measures

Primary Outcomes (1)

• Number of Participants Showing Improvement or no Further Progression of Motor Deficits at 1 Month Following Radiotherapy

  Overall response was defined as improvement or no further progression of motor deficits following radiotherapy. Motor function was graded with the following 8-point scale: 0, complete paraplegia; 1, palpable or visible muscle contractions; 2, active movement of the leg without gravity; 3, active movement against gravity; 4, active movement against mild resistance; 5, active movement against intermediate resistance; 6, active movement against strong resistance; and 7, normal strength. Motor function was recorded separately for each leg resulting in total points of 0 to 14. Improvement of motor function was defined as an increase by at least 2 points compared to baseline. No further progression was defined as +/-1 point (i.e. +1 point, +/- 0 points or -1 point).

  at 1 month following radiotherapy

Secondary Outcomes (7)

• Number of Participants Who Were Able to Walk at 1 Month Following Radiotherapy

  at 1 month following radiotherapy

• Number of Participants Who Were Alive at 6 Months Following Radiotherapy Without Deterioration of Motor Function During (or Directly Following) Radiotherapy and Freedom From In-field Recurrence of Metastatic Spinal Cord Compression Following Radiotherapy

  6 months following radiotherapy

• Number of Participants Who Experienced Relief of Distress at 1 Month Following Radiotherapy Compared to Baseline

  at 1 month following radiotherapy

• Number of Participants Who Experienced Relief of Pain at 1 Month Following Radiotherapy Compared to Baseline

  at 1 month following radiotherapy

• Number of Participants Who Were Alive at 6 Months Following Radiotherapy

  6 months following radiotherapy

Study Arms (2)

5 x 4 Gy in 1 week

EXPERIMENTAL

radiotherapy with 5 x 4 Gy in 1 week (5 x 4 Gy per week)

Radiation: radiotherapy

10 x 3 Gy in 2 weeks

ACTIVE COMPARATOR

radiotherapy with 10 x 3 Gy in 2 weeks (5 x 3 Gy per week)

Radiation: radiotherapy

Interventions

radiotherapy RADIATION

external beam radiotherapy (5 x 4 Gy versus 10 x 3 Gy)

10 x 3 Gy in 2 weeks; 5 x 4 Gy in 1 week

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Motor deficits of the lower extremities resulting from metastatic epidural spinal cord compression, which have persisted for no longer than 30 days
• Confirmation of diagnosis by magnetic resonance imaging (spinal computed tomography allowed)
• Relatively poor survival prognosis (defined as ≤35 points on the survival score published in Cancer 2008)
• Written informed consent

You may not qualify if:

• Prior radiotherapy or surgery of the spinal areas affected by MESCC
• History of symptomatic brain tumor or symptomatic brain metastases
• Metastases of the cervical spine only
• Other severe neurological disorders
• Pregnancy, Lactation
• Indication for decompressive surgery + stabilization of the affected spinal areas

Sponsors & Collaborators

• Prof. Dirk Rades, MD: lead

Study Sites (15)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Oberschwabenklinik Ravensburg

Ravensburg, Baden-Wutemberg, 88191, Germany

Location

Klinikum Bayreuth

Bayreuth, Bavaria, 95445, Germany

Location

University of Regensburg

Regensburg, Bavaria, 93053, Germany

Location

University of Würzburg

Würzburg, Bavaria, 97080, Germany

Location

Ruhr University

Bochum, North Rhine-Westphalia, 44801, Germany

Location

Radiotherapy Practice Dresden-Friedrichstadt

Dresden, Saxony, 01067, Germany

Location

University of Lübeck

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Charite Berlin

Berlin, 10117, Germany

Location

Center of Radiotherapy and Radiation Oncology

Bremen, 28239, Germany

Location

Institute of Oncology, Vilnius University

Vilnius, Lithuania

Location

Saad Specialist Hospital

Khobar, Saudi Arabia

Location

Institute of Oncology

Ljubljana, Slovenia

Location

Consorcio Hospitalario Provencial de Castellon

Valencia, Castellon, Spain

Location

Cruces University Hospital

Barakaldo, Vizcaya (Basque Country), 48903, Spain

Location

Related Publications (20)

• Maranzano E, Latini P. Effectiveness of radiation therapy without surgery in metastatic spinal cord compression: final results from a prospective trial. Int J Radiat Oncol Biol Phys. 1995 Jul 15;32(4):959-67. doi: 10.1016/0360-3016(95)00572-g.

  PMID: 7607970 BACKGROUND

• Sorensen S, Borgesen SE, Rohde K, Rasmusson B, Bach F, Boge-Rasmussen T, Stjernholm P, Larsen BH, Agerlin N, Gjerris F, et al. Metastatic epidural spinal cord compression. Results of treatment and survival. Cancer. 1990 Apr 1;65(7):1502-8. doi: 10.1002/1097-0142(19900401)65:73.0.co;2-d.

  PMID: 2311062 BACKGROUND

• Helweg-Larsen S, Sorensen PS, Kreiner S. Prognostic factors in metastatic spinal cord compression: a prospective study using multivariate analysis of variables influencing survival and gait function in 153 patients. Int J Radiat Oncol Biol Phys. 2000 Mar 15;46(5):1163-9. doi: 10.1016/s0360-3016(99)00333-8.

  PMID: 10725627 BACKGROUND

• Leviov M, Dale J, Stein M, Ben-Shahar M, Ben-Arush M, Milstein D, Goldsher D, Kuten A. The management of metastatic spinal cord compression: a radiotherapeutic success ceiling. Int J Radiat Oncol Biol Phys. 1993 Sep 30;27(2):231-4. doi: 10.1016/0360-3016(93)90232-k.

  PMID: 8407396 BACKGROUND

• Rades D, Blach M, Bremer M, Wildfang I, Karstens JH, Heidenreich F. Prognostic significance of the time of developing motor deficits before radiation therapy in metastatic spinal cord compression: one-year results of a prospective trial. Int J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1403-8. doi: 10.1016/s0360-3016(00)01408-5.

  PMID: 11121640 BACKGROUND

• Rades D, Heidenreich F, Bremer M, Karstens JH. Time of developing motor deficits before radiotherapy as a new and relevant prognostic factor in metastatic spinal cord compression: final results of a retrospective analysis. Eur Neurol. 2001;45(4):266-9. doi: 10.1159/000052141.

  PMID: 11385267 BACKGROUND

• Rades D, Heidenreich F, Karstens JH. Final results of a prospective study of the prognostic value of the time to develop motor deficits before irradiation in metastatic spinal cord compression. Int J Radiat Oncol Biol Phys. 2002 Jul 15;53(4):975-9. doi: 10.1016/s0360-3016(02)02819-5.

  PMID: 12095565 BACKGROUND

• Arcangeli G, Giovinazzo G, Saracino B, D'Angelo L, Giannarelli D, Arcangeli G, Micheli A. Radiation therapy in the management of symptomatic bone metastases: the effect of total dose and histology on pain relief and response duration. Int J Radiat Oncol Biol Phys. 1998 Dec 1;42(5):1119-26. doi: 10.1016/s0360-3016(98)00264-8.

  PMID: 9869238 BACKGROUND

• Niewald M, Tkocz HJ, Abel U, Scheib T, Walter K, Nieder C, Schnabel K, Berberich W, Kubale R, Fuchs M. Rapid course radiation therapy vs. more standard treatment: a randomized trial for bone metastases. Int J Radiat Oncol Biol Phys. 1996 Dec 1;36(5):1085-9. doi: 10.1016/s0360-3016(96)00388-4.

  PMID: 8985030 BACKGROUND

• 8 Gy single fraction radiotherapy for the treatment of metastatic skeletal pain: randomised comparison with a multifraction schedule over 12 months of patient follow-up. Bone Pain Trial Working Party. Radiother Oncol. 1999 Aug;52(2):111-21.

  PMID: 10577696 BACKGROUND

• Steenland E, Leer JW, van Houwelingen H, Post WJ, van den Hout WB, Kievit J, de Haes H, Martijn H, Oei B, Vonk E, van der Steen-Banasik E, Wiggenraad RG, Hoogenhout J, Warlam-Rodenhuis C, van Tienhoven G, Wanders R, Pomp J, van Reijn M, van Mierlo I, Rutten E. The effect of a single fraction compared to multiple fractions on painful bone metastases: a global analysis of the Dutch Bone Metastasis Study. Radiother Oncol. 1999 Aug;52(2):101-9. doi: 10.1016/s0167-8140(99)00110-3.

  PMID: 10577695 BACKGROUND

• Rades D, Stalpers LJ, Veninga T, Schulte R, Hoskin PJ, Obralic N, Bajrovic A, Rudat V, Schwarz R, Hulshof MC, Poortmans P, Schild SE. Evaluation of five radiation schedules and prognostic factors for metastatic spinal cord compression. J Clin Oncol. 2005 May 20;23(15):3366-75. doi: 10.1200/JCO.2005.04.754.

  PMID: 15908648 BACKGROUND

• Emami B, Lyman J, Brown A, Coia L, Goitein M, Munzenrider JE, Shank B, Solin LJ, Wesson M. Tolerance of normal tissue to therapeutic irradiation. Int J Radiat Oncol Biol Phys. 1991 May 15;21(1):109-22. doi: 10.1016/0360-3016(91)90171-y.

  PMID: 2032882 BACKGROUND

• Barendsen GW. Dose fractionation, dose rate and iso-effect relationships for normal tissue responses. Int J Radiat Oncol Biol Phys. 1982 Nov;8(11):1981-97. doi: 10.1016/0360-3016(82)90459-x. No abstract available.

  PMID: 6759484 BACKGROUND

• Koswig S, Budach V. [Remineralization and pain relief in bone metastases after after different radiotherapy fractions (10 times 3 Gy vs. 1 time 8 Gy). A prospective study]. Strahlenther Onkol. 1999 Oct;175(10):500-8. doi: 10.1007/s000660050061. German.

  PMID: 10554645 BACKGROUND

• Rades D, Dunst J, Schild SE. The first score predicting overall survival in patients with metastatic spinal cord compression. Cancer. 2008 Jan 1;112(1):157-61. doi: 10.1002/cncr.23150.

  PMID: 17948910 BACKGROUND

• Tomita T, Galicich JH, Sundaresan N. Radiation therapy for spinal epidural metastases with complete block. Acta Radiol Oncol. 1983;22(2):135-43. doi: 10.3109/02841868309134353.

  PMID: 6310968 BACKGROUND

• Maranzano E, Bellavita R, Rossi R, De Angelis V, Frattegiani A, Bagnoli R, Mignogna M, Beneventi S, Lupattelli M, Ponticelli P, Biti GP, Latini P. Short-course versus split-course radiotherapy in metastatic spinal cord compression: results of a phase III, randomized, multicenter trial. J Clin Oncol. 2005 May 20;23(15):3358-65. doi: 10.1200/JCO.2005.08.193. Epub 2005 Feb 28.

  PMID: 15738534 BACKGROUND

• Rades D, Segedin B, Conde-Moreno AJ, Ferrer-Albiach C, Metz M, Polat B, Badakhshi H, Schreiber A, Nitsche M, Cacicedo J, Schild SE. Patient-Reported Outcomes-Secondary Analysis of the SCORE-2 Trial Comparing 4 Gy x 5 to 3 Gy x 10 for Metastatic Epidural Spinal Cord Compression. Int J Radiat Oncol Biol Phys. 2019 Nov 15;105(4):760-764. doi: 10.1016/j.ijrobp.2019.08.002. Epub 2019 Aug 12.

  PMID: 31415797 DERIVED

• Rades D, Segedin B, Conde-Moreno AJ, Garcia R, Perpar A, Metz M, Badakhshi H, Schreiber A, Nitsche M, Hipp P, Schulze W, Adamietz IA, Norkus D, Rudat V, Cacicedo J, Schild SE. Radiotherapy With 4 Gy x 5 Versus 3 Gy x 10 for Metastatic Epidural Spinal Cord Compression: Final Results of the SCORE-2 Trial (ARO 2009/01). J Clin Oncol. 2016 Feb 20;34(6):597-602. doi: 10.1200/JCO.2015.64.0862. Epub 2016 Jan 4.

  PMID: 26729431 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Prof. Dr. Dirk Rades
• Organization: Department of Radiation Oncology, University of Lübeck, Germany

dirk.rades@uksh.de

0049 451 500

Study Officials

• Dirk Rades, MD

  Department of Radiation Oncology, University of Lübeck, Germany

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. Dirk Rades. MD

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 14, 2014
• Study Start: July 1, 2010
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 5, 2020
• Results First Posted: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1); SA (1); DE (9); ES (2); SL (1); US (1)