Adaptive Radiation Dose Escalation for Non-Small Cell Lung Cancer

(PET-BOOST Trial)

Not currently recruiting at 9 trial locations

Overseen By David Palma, MD, FRCPC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Disqualifiers: Uncontrolled cardiac disease, COPD, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if increasing the radiation dose to active parts of a lung tumor can better control cancer compared to standard treatment. It involves patients with non-small cell lung cancer who are already receiving chemotherapy and radiation. Participants will either continue with chemoradiotherapy (a combination of chemotherapy and radiation therapy) or receive an additional radiation boost to specific tumor areas. The trial seeks individuals with lung tumors that appear prominently on a PET scan and who have been using chemotherapy and radiation as their main treatment. As an unphased trial, this study offers a unique opportunity to contribute to innovative cancer treatment research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining chemotherapy with targeted radiation for non-small cell lung cancer is generally safe. This method focuses higher doses of radiation on specific tumor areas and is well-tolerated by patients. Those receiving this treatment alongside chemotherapy have experienced effective results with manageable side effects.

While side effects remain a risk, evidence suggests this treatment is a viable option for patients with advanced lung cancer. It targets cancer more precisely, potentially reducing side effects compared to traditional methods.

Overall, research supports the safety of this combined treatment approach. However, individual experiences may vary, so discussing any concerns with a doctor is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for non-small cell lung cancer because they're exploring ways to deliver a more targeted and powerful punch to the cancer cells. While standard chemoradiotherapy typically administers a consistent radiation dose, the experimental approach includes an integrated boost dose of up to 85 gray (Gy) to specific tumor subvolumes, aiming to maximize the impact on the cancer while minimizing damage to surrounding healthy tissue. This tailored radiation approach could potentially enhance the effectiveness of the treatment and improve patient outcomes.

What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?

In this trial, participants will be randomized into one of two treatment arms. The standard arm involves chemoradiotherapy, where patients receive radiotherapy (5x per week) of 60 gray (Gy) in 30 fractions with concurrent cisplatin and etoposide chemotherapy. The experimental arm involves chemoradiotherapy with an integrated boost dose, where patients receive radiotherapy (5x per week) with an integrated boost dose of up to 85Gy in 30 fractions to tumor subvolumes, also with concurrent cisplatin and etoposide chemotherapy.

Research has shown that combining chemotherapy and radiation therapy, with an extra boost of radiation, can effectively treat advanced non-small cell lung cancer (NSCLC). Studies suggest this method may extend patient survival compared to standard treatments. Specifically, intensity-modulated radiation therapy (IMRT) has been linked to fewer serious side effects on the lungs and heart, which is encouraging. Additionally, focusing higher doses of radiation on active tumor areas might reduce the risk of cancer recurrence in the treated area. Overall, evidence suggests this approach could lead to better outcomes for patients with this type of lung cancer. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

Adults with locally advanced non-small cell lung cancer who can undergo chemoradiotherapy, have a certain level of physical fitness (ECOG status 0-2), and tumors visible on scans. Excluded are those with poor respiratory function, significant recent weight loss, inadequate bone marrow reserve, other active cancers, severe heart or lung conditions, liver issues, pregnancy, or AIDS.

Inclusion Criteria

I can care for myself and am up and about more than 50% of my waking hours.

My tumor or lymph node is at least 10mm large as shown on a CT scan.

I will be treated with both chemotherapy and radiation as my main treatment.

Exclusion Criteria

I have another active cancer besides lung cancer.

I have had radiotherapy in the areas where I now need treatment.

I had surgery as part of my cancer treatment plan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive chemoradiotherapy with or without an integrated boost dose, including concurrent cisplatin and etoposide chemotherapy

6 weeks

5 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of local-regional failure rate and quality of life

2 years

Regular visits (frequency not specified)

What Are the Treatments Tested in This Trial?

Interventions

• Chemoradiotherapy
• Chemoradiotherapy with Integrated Boost Dose

Trial Overview This phase II trial is testing if increasing the radiation dose to parts of the tumor that show more activity on PET scans can lower the chance of cancer returning within two years. Patients will either receive standard chemoradiotherapy or an intensified version targeting these active tumor areas.

How Is the Trial Designed?

Group I: Chemoradiotherapy with Integrated Boost Dose Experimental Treatment 1 Intervention

Patients randomized to the experimental arm will receive radiotherapy (5x per week) with an integrated boost dose of up to 85Gy in 30 fractions to tumor subvolumes, with concurrent cisplatin and etoposide chemotherapy.

Group II: Chemoradiotherapy Active Control 1 Intervention

Patients randomized to the standard arm will receive radiotherapy (5x per week) of 60 gray (Gy) in 30 fractions with concurrent cisplatin and etoposide chemotherapy.

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5564751/

A retrospective study - PMC - PubMed Central SIB-IMRT, especially with concurrent chemotherapy, appears to be an effective and safe option to treat patients with locally advanced NSCLC. More prospective ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0167814021060825

Adaptive intensity-modulated radiotherapy with ... Intensity-modulated radiation therapy (IMRT) was found to be associated with lower severe lung toxicities and lower cardiac doses, and it may improve tumor ...

3. redjournal.org redjournal.org/article/S0360-3016(24)02949-3/fulltext

Enhancing Outcomes in Locally Advanced Non-Small Cell ... A phase 2 trial of primary tumor stereotactic body radiation therapy boost before concurrent chemoradiation for locally advanced non-small cell lung cancer.

4. link.springer.com link.springer.com/article/10.1007/s12672-025-02046-9

Simultaneous integrated dose reduction intensity ... The SIR-IMRT group demonstrated better overall survival (OS) than the C-IMRT group, with a median OS of 37.7 versus 31.2 months. The SIR-IMRT ...

5. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2813829

Accelerated Hypofractionated Chemoradiation Followed by ... This early-phase, dose-escalation nonrandomized controlled trial showed that concurrent chemoradiation with an adaptive SABR boost to 70 Gy in 15 fractions ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28467775/

Simultaneous integrated boost intensity-modulated ... SIB-IMRT, especially with concurrent chemotherapy, appears to be an effective and safe option to treat patients with locally advanced NSCLC.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213260024001899

High-dose hyperfractionated simultaneous integrated ... High-dose thoracic radiotherapy (54 Gy in 30 fractions) significantly improved overall survival, progression-free survival, and local progression-free survival ...

8. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-021-09099-3

Dose-escalation by hypofractionated simultaneous integrated ... Prospective, risk-adapted strategy of stereotactic body radiotherapy for early-stage non–small-cell lung Cancer: results of a phase II trial.