Volumetric Intensity Modulated Arc Therapy vs. Conventional Radiotherapy for Cancer Pain

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Completed

Conditions: Radiotherapy Side Effect; Quality of Life; Neoplasm Metastasis; Pain

Treatments: Radiation: Volumetric Intensity-Modulated Arc Therapy; Radiation: Conventional Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03374592

CE14.046

Details and patient eligibility

About

This study compares the use of conventional radiotherapy technique with volumetric intensity-modulated radiotherapy (VMAT) in the treatment of painful cancer metastases. Half of the patients will receive radiotherapy using a conventional technique, while the other half will receive their treatment using a the VMAT technique.

Full description

Radiotherapy to painful sites of metastasis can provide pain relief.

Side-effects from radiotherapy is dependent on the volume and dose received by normal tissues. Conventional radiotherapy techniques delivers similar doses of radiation to the targeted cancer lesion and the normal tissues along the entrance and exit paths of the radiation.

Volumetric intensity-modulated arc therapy (VMAT) is an advanced technique of radiotherapy that spares normal tissues from receiving high-dose irradiation. However, VMAT increases the volume of normal tissues receiving low-dose irradiation.

This study aims at comparing the quality of life and side-effect profiles of patients treated by palliative radiotherapy using the conventional technique vs. VMAT.

Enrollment: 73 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pain (SF-BPI score ≥1) should be related to metastases (bone or others) or to the tumor itself

2. Capable of providing the full list of analgesic medication being used

3. Capable of completing the SF-BPI and EORTC questionnaires without any help

4. Life expectancy of at least 3 month

5. KPS greater or equal to 50

6. Radiotherapy to 1 site pain

7. Site of treatment not previously irradiated

8. No planned changes in analgesic within 7 days before and after treatment

   • Patient may be started on Dexamethasone on the first day of radiotherapy

9. No planned chemotherapy, radiotherapy or surgery within 7 days before and after treatment

10. Patient provided informed consent to participate in this study

Exclusion criteria

1. Major mental or psychiatric impairments, which in the investigator's opinion will prevent administration or completion of the protocol therapy and/or interfere with follow-up.
2. Treatment to upper and lower limb
3. Treatment to 2 or more sites of pain
4. Re-irradiation of the site of treatment
5. Women who are pregnant
6. Life expectancy less than 3 month

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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73 participants in 2 patient groups

Conventional Radiotherapy

Active Comparator group

Description:

8Gy in 1 fraction or 20Gy in 5 fractions

Treatment:

Radiation: Conventional Radiotherapy

Volumetric Intensity-Modulated Arc Therapy

Experimental group

Description:

8Gy in 1 fraction or 20Gy in 5 fractions

Treatment:

Radiation: Volumetric Intensity-Modulated Arc Therapy