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A Phase II Trial Evaluating the Efficacy of a Radio-Biological Based Re-Irradiation Strategy for Patients With Malignant Spinal Cord Compression


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pain, Radiation Toxicity, Spinal Cord Compression, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase II Trial Evaluating the Efficacy of a Radio-Biological Based Re-Irradiation Strategy for Patients With Malignant Spinal Cord Compression


OBJECTIVES:

Primary

- To determine the efficacy of a biologically effective dose-based re-irradiation
strategy, in terms of the response rate (based on the mobility score using the Tomita
scale where improvement in mobility or stable mobility score will be regarded as a
response) in patients with malignant spinal cord compression.

Secondary

- To determine quality of life as assessed by the EORTC QLQ-C15 PAL version 1.0
questionnaire.

- To determine the non-spinal radiation-induced toxicity using standard RTOG criteria.

- To determine the rate of long-term spinal toxicity and radiation-induced myelopathy
using the RTOG SOMA morbidity grading system.

OUTLINE: Patients are divided into 2 groups according to the interval since their most
recent radiotherapy to the involved area of the spinal cord.

- Group 1 (< 6 months since prior radiotherapy): Patients undergo radiotherapy for a
cumulative biologically effective dose (BED) ≤ 100 Gy_2 in addition to receiving other
current treatment.

- Group 2 (≥ 6 months since prior radiotherapy): Patients undergo radiotherapy for a
cumulative BED ≤ 130 Gy_2 in addition to receiving other current treatment.

Mobility score is assessed and patients complete a quality-of-life assessment at baseline
and at each follow-up visit starting at week 5.

After completion of study treatment, patients are followed up at 1 and 5 weeks, at 3 months,
and then every 3 months thereafter.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- MRI-confirmed diagnosis of malignant spinal cord compression

- MRI of the entire spine performed

- Histologically proven malignancy

- No primary tumors of the spine or vertebral column

- Undergone previous radiotherapy to the involved area of the spinal cord (e.g., full
segment and/or ≥ 2 cm in cranio-caudal of overlap between the 2 areas treated)

- Maximum biologically effective dose received from previous irradiation ≤ 90 Gy_2

- Deemed not suitable for neurosurgical intervention at the time of initial assessment

- Patients deemed inoperable are eligible

PATIENT CHARACTERISTICS:

- Karnofsky performance status 40-100%

- Short life expectancy

- No medical or psychiatric condition that, in the opinion of the investigator or
research team, contraindicates participation in this study

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response to treatment as assessed by mobility via the Tomita mobility scale

Outcome Time Frame:

5 weeks after completion of radiation therapy

Safety Issue:

No

Principal Investigator

Pierre Thirion, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Saint Luke's Hospital

Authority:

Ireland: Irish Medicines Board

Study ID:

CDR0000644385

NCT ID:

NCT00974168

Start Date:

October 2007

Completion Date:

Related Keywords:

  • Pain
  • Radiation Toxicity
  • Spinal Cord Compression
  • Unspecified Adult Solid Tumor, Protocol Specific
  • pain
  • radiation toxicity
  • spinal cord compression
  • unspecified adult solid tumor, protocol specific
  • Spinal Cord Compression
  • Radiation Injuries

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