Recruiting
Phase 2

Adaptive Radiotherapy

Sponsor:

AHS Cancer Control Alberta

Code:

NCT04952480

Conditions

Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dose-escalated adaptive radiotherapy

Chemotherapy

Study Details

Brief summary:

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.

Conditions

Small Cell Lung Cancer

Study ID

NCT04952480

Start date

Jun 13, 2022

Status verified date

Jun, 2025

Completion date

Nov 1, 2025

Anticipated

Primary completion date

Nov 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

31 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose-escalated adaptive chemoradiotherapy

Concurrent with standard of care platinum doublet based chemotherapy (cisplatin + etoposide), radiation treatment plan will be delivered in three sequential phases with two scheduled replans during the treatment along with scaled dose limits for organs-at-risk: Phase 1 dose prescription = 14 Gy in 7 fractions; Phase 2 dose prescription = 10 Gy in 5 fractions starting the day after the final (7th) fraction is delivered; Phase 3 dose prescription = either a) 70 Gy in 35 fractions, or if this cannot be safely reached without exceeding the dose limit of an organ-at-risk, b) the maximum safe prescribe-able dose tolerance specified in the protocol. Either 3D conformal radiotherapy or IMRT planning and delivery techniques will be employed, including contouring relevant thoracic organs-at-risk. All CT simulation scans will be without contrast.

Interventions

Dose-escalated adaptive radiotherapy

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

Concurrent standard of care platinum doublet based therapy

Primary outcome measure

  • Local failure rate [ Time Frame: The local failure rate will be assessed at the time point of 24 months. ]

Central Contacts and Locations

Central contacts

Yee Don, MD

780-432-8783don.yee@ahs.ca

Locations

Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

More Information

Sponsor

AHS Cancer Control Alberta

Last update posted

Jun 12, 2025

Last verified

Jun, 2025

Keywords

  • Small cell lung cancer
  • (Dose-escalated) Adaptive radiotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AHS Cancer Control Alberta on 2025-06-12.