Health TrialsbyHealthPanel

Dose-escalated Adaptive Radiotherapy of Thoracic Disease for Small Cell Lung Cancer

ConditionSmall Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAHS Cancer Control Alberta

About this trial

The purpose of this study is to find out what effects of using adaptive radiotherapy to deliver chest radiation has on the ability to control lung cancer and side effects.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Dose-escalated adaptive radiotherapy

    Radiation

    Adaptive planning of Radiation Therapy with two re-plans of the treatment field through course of therapy with the shrinking treatment fields according to tumor response to escalate dose, as allowed by dose to organs-at-risk.

  • Chemotherapy

    Drug

    Concurrent standard of care platinum doublet based therapy

Treatment groups

31 Participants
are divided into 1 treatment group
Group A: Dose-escalated adaptive chemoradiotherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Local failure rate

The time from diagnostic biopsy to documented progression of intrathoracic disease as assessed by CT or X-ray imaging.

Time frame
The local failure rate will be assessed at the time point of 24 months.

Secondary outcomes

1

Progression-free survival

Time from diagnostic biopsy to first documented clinical or radiographic evidence of local progression or new metastatic disease.

Time frame
Median time to PFS in study population. Expected to be within 24 months.
2

Overall survival

Time from diagnostic biopsy to death of the patient.

Time frame
Median time to OS in study population. Expected to be within 24 months.
3

Acute radiation toxicity

Toxicity during and in the 3 months after radiotherapy as defined by CTCAE v.5 for esophagus, skin, lung, heart, and subcutaneous tissue.

Time frame
Expected to be within 3 months.
4

Late radiation toxicity

Toxicity seen 3 months after radiotherapy as defined by CTCAE v.5 for esophagus, skin, lung, heart, and subcutaneous tissue.

Time frame
Late toxicity will be assessed up to 24 months post-treatment.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AHS Cancer Control Alberta

Lead sponsor

Source ClinicalTrials.gov
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