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Compares treatment options for Histopathologically or Cytologically Confirmed Solid Tumor Who...
Official title Lattice Radiation Therapy Versus Conventional Radiation Therapy for the Palliation of Large Tumors
ClinicalTrials.gov ID: NCT07444775
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Diagnosis of solid tumor by at least one criterion below: a. Pathologically or cytologically proven solid tumor greater than 5 cm (largest dimension)...
- Eastern Cooperative Oncology Group (ECOG) Status: 0-4 within 14 days of randomization
- In the investigator's opinion, patient requires palliative radiation therapy to a lesion \>5 cm measured in one of the following ways:
- Imaging performed within 90 days prior to randomization per Response Evaluation Criteria in Solid Tumors (RECIST)
- CT simulation performed for radiation planning
You likely can't join if
- Prior radiotherapy that would result in substantial overlap of the irradiated volume thus precluding per protocol treatment
- Requirement for urgent surgical intervention prior to radiation treatment
- Confirmed pregnancy
- Hematologic primary malignancy
- Medical condition precluding the delivery of per protocol treatment (e.g. connective tissue disorder)
- Tumors overlying critical CNS, heart or spinal cord compression
See the full eligibility criteria
- Diagnosis of solid tumor by at least one criterion below: a. Pathologically or cytologically proven solid tumor greater than 5 cm (largest dimension) from a primary site or site of metastasis and unsuitable for surgical...
- Eastern Cooperative Oncology Group (ECOG) Status: 0-4 within 14 days of randomization
- In the investigator's opinion, patient requires palliative radiation therapy to a lesion \>5 cm measured in one of the following ways:
- Imaging performed within 90 days prior to randomization per Response Evaluation Criteria in Solid Tumors (RECIST)
- CT simulation performed for radiation planning
- Able to understand and provide written consent
- Willing and have the ability to complete the baseline and post-treatment questionnaires (short form brief-pain inventory) and to maintain a pain diary
- Patient is not pregnant, planning on becoming pregnant or planning on fathering a child in the next 90 days
- Patient must be accessible for treatment and follow-up. Investigators must ensure the patients assigned by chance on this trial will be available for complete documentation of the treatment, adverse events, and follow-up
- Prior radiotherapy that would result in substantial overlap of the irradiated volume thus precluding per protocol treatment
- Requirement for urgent surgical intervention prior to radiation treatment
- Confirmed pregnancy
- Hematologic primary malignancy
- Medical condition precluding the delivery of per protocol treatment (e.g. connective tissue disorder)
- Tumors overlying critical CNS, heart or spinal cord compression
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.