Lattice vs Conventional Radiation Therapy for Cancer

(LATTICE-PAL Trial)

Overseen By Jelena Lukovic, MD FRCPC MPH MRMD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University Health Network, Toronto

Disqualifiers: Prior radiotherapy, Hematologic malignancy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 5 fractions

148 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this randomized, phase III trial is to to determine if Spatially Fractionated Lattice Radiotherapy (SFRT) known as LATTICE therapy, leads to a greater reduction in pain or discomfort compared with conventional Radiation Therapy (RT) in patients with large tumours. This is evaluated by assessing if a greater proportion of patients who receive RT with SFRT will have an improvement in pain/discomfort at 30 days defined using the International Consensus Pain Response (ICPR) compared with those treated with conventional RT.

Are You a Good Fit for This Trial?

Inclusion Criteria

I have a solid tumor larger than 5 cm that cannot be removed by surgery or treated with radiation, or I have liver cancer diagnosed by imaging tests.

My physical activity level has been assessed recently.

* Imaging performed within 90 days prior to randomization per Response Evaluation Criteria in Solid Tumors (RECIST)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either conventional radiation therapy or lattice radiation therapy

5 fractions

5 visits (in-person)

Follow-up

Participants are monitored for pain response and treatment-related toxicity

6 months

Visits at 1, 3, and 6 months post-treatment

Long-term follow-up

Participants are monitored for overall survival and progression-free survival

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Conventional Radiation Therapy
• Lattice Radiation Therapy

How Is the Trial Designed?

Group I: Arm B "Lattice Radiation Therapy" Experimental Treatment 1 Intervention

Spatially fractionated radiation therapy, via LATTICE Radiotherapy (LRT), 20Gy in 5 fractions with boost of 67Gy in 5 fractions with boost of 67Gy in 5 fractions to discrete sub-volumes within a tumour

Group II: Arm A "Conventional Radiation Therapy" Experimental Treatment 1 Intervention

Homogenous RT (20Gy to 35Gy in 5 fractions), planned using volumetric modulated arc therapy or 3D conformal radiotherapy (3DCRT)

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+