Adaptive radiotherapy for small cell lung cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effects of dose-escalated adaptive radiotherapy on controlling small cell lung cancer and managing side effects. It is an open-label, single-arm, phase II trial that compares this innovative radiotherapy approach to historical controls of standard treatment. Participants will receive tailored radiation therapy in three phases, with scheduled replans to adjust for tumor shrinkage, while also undergoing chemotherapy. The study aims to assess local failure rates, progression-free survival, overall survival, and radiation toxicity over a follow-up period of 24 months.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Minimum 18 years of age
* Biopsy proven, newly diagnosed, untreated SCLC
* Completed standard of care staging investigations including: CT chest/abdomen/pelvis, bone scan and/or or PET-CT scan, CT head or MRI brain, or chest X-ray
* Eligible for platinum doublet chemotherapy
* Eligible for thoracic radiotherapy, which can also include ipsilateral supraclavicular lymph node disease
* Capable of providing written, informed consent prior to participation in the study. Patient's legally authorized representative (LAR) may sign on behalf of the patient.
* Able and willing to comply with protocol rules and follow-up regimen
* Performance status of ECOG 0-2
* Pulmonary function tests showing FEV-1 \>1.0L and DLCO \> 50% predicted
* Radiation-targetable intrathoracic disease

Exclusion Criteria:

* No intrathoracic disease seen to target with radiation
* Thoracic disease is contiguous to extra-thoracic sites, beyond ipsilateral supraclavicular lymph nodes
* Mixed histology disease
* Active serious infection requiring therapy
* Brain metastasis that has not been symptomatically stable on dexamethasone
* 4 or more sites of extrathoracic disease, even if 2 or more of these are present in the same organ system
* Previous CNS or thoracic radiotherapy
* Previous chemotherapy
* Ineligibility for platinum doublet chemotherapy
* Life expectancy of less than 3 months
* Prior thoracic surgery
* History of another primary malignancy other than cutaneous basal cell carcinoma unless disease-free for at least 5 years
* Pregnant or breast-feeding
* In LS-SCLC, patients that are not eligible for concurrent chemoradiotherapy
* In ES-SCLC, patients that are not eligible for concurrent chemoradiotherapy under the experimental arm
* CT contrast allergy or kidney disease with irreversibly low creatinine clearance inadequate for IV contrast administration (for the purposes of high quality contrast enhanced CT chest and abdomen for follow-up imaging)
* Lack of intrathoracic disease or intrathoracic disease spread not feasible to treat with adaptive radiotherapy
* Participant in development and conduct of the research study

Where it's running

• Cross Cancer Institute
  Edmonton, Alberta, Canada Recruiting

Study contacts

• Principal investigator: Yee Don, MD — Cross Cancer Institute, Alberta Health Services
• Study coordinator: Yee Don, MD
• Email: don.yee@ahs.ca
• Phone: 780-432-8783

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.