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

NCT04952480 | Recruiting Phase 2 DMC

• 1 other identifier: IIT-0015
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

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.

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

Secondary Outcomes (4)

• Progression-free survival

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

• Overall survival

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

• Acute radiation toxicity

  Expected to be within 3 months.

• Late radiation toxicity

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

Study Arms (1)

Dose-escalated adaptive chemoradiotherapy

EXPERIMENTAL

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.

Radiation: Dose-escalated adaptive radiotherapy; Drug: Chemotherapy

Interventions

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.

Dose-escalated adaptive chemoradiotherapy

Chemotherapy DRUG

Concurrent standard of care platinum doublet based therapy

Dose-escalated adaptive chemoradiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Yee Don, MD

  Cross Cancer Institute, Alberta Health Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yee Don, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 7, 2021
• Study Start: June 13, 2022
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)