High Dose Radiotherapy for Palliation (Hi-D)

British Columbia Cancer Agency

Status: Not yet enrolling

Conditions: Palliative Radiotherapy; Metastases

Treatments: Radiation: Palliative Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07291895

Hi-D

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the feasibility of single-blind randomization between two palliative regimens - standard 24 Gray in 3 fractions vs a high-dose (Hi-D) 27 Gray in 3 fractions with dose escalation within the tumor in participants with bulky metastatic cancer.

The main question

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must meet all the following criteria to be eligible for participation in this study:

• Age 18 or older.

• Able to provide informed consent

• Patient has histologically confirmed solid tumour malignancy

• ECOG performance status 0 - 2

• Life Expectancy > 6 months

• 1-5 target lesions larger than 5cm

• A history and physical exam, including ECOG performance status, performed within 6 weeks prior to trial enrollment

• Not suitable for or declined curative-intent treatment

• Subject has had a CT neck, chest, abdomen and pelvis or PET-CT within 8 weeks prior to enrollment, and with 12 weeks of treatment

• MRI spine for patients receiving RT to vertebral or paraspinal metastases

• Patient is judged able to:

  • Maintain a stable position during therapy
  • Tolerate immobilization device(s) that may be required to deliver radiation safely

Exclusion criteria

• - Hematologic malignancy.
• Disease limited to intracranial sites
• Serious medical co-morbidities precluding radiotherapy
• Bone metastases with no soft tissue component
• Prior radiation to target lesion that precludes delivery of repeat radiation. All such cases should be discussed with the local and study PIs.
• Pregnant women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

High-Dose RT

Experimental group

Description:

27Gy in 3 fractions with boost

Treatment:

Radiation: Palliative Radiotherapy

Radiation: Palliative Radiotherapy

Standard Dose Palliative RT

Active Comparator group

Description:

24Gy in 3 fractions

Treatment:

Radiation: Palliative Radiotherapy

Radiation: Palliative Radiotherapy