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

NCT ID: NCT04952480

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-13
• Study Completion Date: 2025-11-01

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.

Detailed Description

This will be an open-label, single-arm, phase II study comparing dose escalated adaptive thoracic radiotherapy to historical control of standard of care single planned radiotherapy field for entire treatment course in patients with newly diagnosed limited stage small cell lung cancer eligible for concurrent chemoradiation with platinum doublet based chemotherapy, or extensive stage small cell lung cancer patients with radiation-targetable intra-thoracic disease and none or limited extra-thoracic disease that are eligible for up-front platinum doublet chemotherapy and are fit to receive concurrent radiotherapy.

The adaptive dose-escalated radiotherapy 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. Up to 70 Gy in 35 fractions can be delivered to the disease without overdosing organs-at-risk, and treatment will last 5 - 7 weeks. Scheduled CT simulations for the replans will be at fraction 5 and fraction 10 to account for the expected rapidly shrinking tumour volumes. Participants will be followed for 24 months to investigate local failure rate, medium progression-free survival, overall survival, acute radiation toxicity, and late radiation toxicity. Follow-up after the study will be as per standard-of-care for secondary endpoints.

Conditions

Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Dose-escalated adaptive radiotherapy

Intervention Type: 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

Intervention Type: DRUG

Concurrent standard of care platinum doublet based therapy

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.

Intervention Type: RADIATION

Chemotherapy

Concurrent standard of care platinum doublet based therapy

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AHS Cancer Control Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yee Don, MD

Role: PRINCIPAL_INVESTIGATOR

Cross Cancer Institute, Alberta Health Services

Locations

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Yee Don, MD

Role: CONTACT

don.yee@ahs.ca

780-432-8783

Other Identifiers

IIT-0015

Identifier Type: -

Identifier Source: org_study_id