Reirradiation Dose Escalation in Thoracic Cancers

Launched by LONDON HEALTH SCIENCES CENTRE RESEARCH INSTITUTE OR LAWSON RESEARCH INSTITUTE OF ST. JOSEPH'S · Aug 14, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating how to safely deliver higher doses of radiation therapy to patients with thoracic cancers, such as lung and esophageal cancer, who have had prior radiation treatment. Sometimes, when patients need more radiation for returning or new cancer in their chest, the amount that can be given is limited due to safety concerns. This study aims to find out the highest dose of radiation that patients can tolerate without experiencing severe side effects, by adjusting how doctors calculate the safe dose based on previous treatments.

To be eligible for this trial, patients must be at least 18 years old and have a confirmed diagnosis of cancer in the chest that requires more radiation. They should have had their last radiation treatment at least six months ago and have a life expectancy of more than six months. Participants will receive careful monitoring during the trial, and their treatment plan will be tailored based on how previous treatments have responded. It’s important for potential participants to know that certain health conditions and previous treatments might prevent them from joining the trial, so a thorough medical history review will be done before enrollment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Pathologically (histologically or cytologically) proven diagnosis of malignancy, with disease in the thorax requiring re-irradiation for any treatment intent. This may include primary lung cancer of any type, esophageal cancer, recurrences, and/or metastasis from any primary. The intrathoracic disease at the time of enrollment does not itself require a biopsy if a prior biopsy has been obtained at that location or another body site. If the risk of biopsy is unacceptable and there is no prior confirmation of malignancy even at the time of the initial course of radiation, enrollment is permitted provided that the case is discussed at a multidisciplinary tumor board or peer-review rounds.
• • Must have received prior photon thoracic radiotherapy ≥ 6 months ago
• • Life expectancy \> 6 months.
• • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• • Age ≥ 18 years
• • The current radiation course, when added to the previous radiation doses, exceeds the normal tissue constraints used for de novo treatments for esophagus, heart, lungs, trachea, bronchus, great vessels, or brachial plexus. Forgiveness of the previous dose (i.e. reduction of the previous dose in the cumulative dose calculation) is required to meet constraints. Submission of a pre-plan summary showing the estimated accumulation of current and previously delivered doses is required for registration.
• Exclusion Criteria:
• • Persistent toxicity from previously delivered radiation therapy
• • Prior development of symptomatic radiation pneumonitis or immunotherapy-related pneumonitis from previous treatment, even if resolved
• • Cumulative radiation dose for all organs-at-risk is already below dose constraints without a recovery factor applied, or with a recovery factor less than the current dose level of the trial. This will be confirmed by the enrolling team after the planning is completed.
• • The reirradiation dose-limiting structure is expected to be spinal cord, chest wall, and/or stomach.
• • Any prior thoracic radiotherapy \< 6 months ago; OR prior thoracic radiotherapy delivered twice daily (compensation for holiday breaks are OK), thoracic radiotherapy delivered by brachytherapy, radionuclides, proton beams, or electron beams.
• • Plans for patient to receive daily adaptive radiotherapy in current plan (computed tomography or magnetic resonance based).
• • Plans for the patient to receive other local therapy (including standard fractionated radiotherapy and/or surgery) while on this study, except at disease progression.
• • Concurrent systemic therapy (i.e. on the same days as radiation) is not allowed, EXCEPT for patients being treated for intrathoracic lung cancer (NSCLC or SCLC) with curative intent.
• • For other patients receiving systemic therapy, they are still eligible for enrollment as long as there is a break in systemic therapy during the course of radiation. For example, if a patient has been on palliative pemetrexed and is planning to continue, they can still be enrolled and would continue to receive pemetrexed; reirradiation would be delivered between cycles, possibly requiring a break in systemic therapy. See Section 6.9 for further details.
• • Prior surgical intervention that has significantly changed the position of an organ-at-risk that is expected to be a dose-limiting structure.
• • Pregnancy
• • The following autoimmune and connective tissue diseases will be excluded: Scleroderma and Systemic lupus erythematosus.
• • Patients with interstitial lung disease (ILD).