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Chemotherapy

Adaptive Radiotherapy for Small Cell Lung Cancer (DARTS Trial)

Phase 2
Recruiting
Led By Yee Don, MD
Research Sponsored by AHS Cancer Control Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Radiation-targetable intrathoracic disease
Eligible for thoracic radiotherapy, which can also include ipsilateral supraclavicular lymph node disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up late toxicity will be assessed up to 24 months post-treatment.
Awards & highlights

DARTS Trial Summary

This trial is testing a new way to give radiation for lung cancer, which may be better at controlling the cancer and have fewer side effects.

Who is the study for?
This trial is for adults with newly diagnosed, untreated Small Cell Lung Cancer (SCLC) who can undergo platinum chemotherapy and thoracic radiotherapy. They must have completed standard cancer staging tests, be able to consent, follow the study plan, and have a performance status of ECOG 0-2. People with severe infections, less than 3 months life expectancy, previous cancers (except certain skin cancers), prior chemo or thoracic surgery are excluded.Check my eligibility
What is being tested?
The study is testing the effects of dose-escalated adaptive radiotherapy in combination with chemotherapy on lung cancer control and side effects. Adaptive radiotherapy adjusts doses based on changes in tumor size or position during treatment to better target the disease.See study design
What are the potential side effects?
Potential side effects may include typical reactions from radiation such as skin irritation at the treatment site, fatigue, difficulty swallowing if treating near the esophagus, nausea or vomiting depending on area treated. Chemotherapy-related side effects could range from hair loss to blood cell count changes.

DARTS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung disease can be treated with radiation.
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I am eligible for chest radiation therapy, including treatment to the lymph nodes above my collarbone.
Select...
I have been newly diagnosed with small cell lung cancer and have not received any treatment.
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I am a candidate for platinum-based chemotherapy.
Select...
I am at least 18 years old.
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I am able to get out of my bed or chair and move around.

DARTS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~late toxicity will be assessed up to 24 months post-treatment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and late toxicity will be assessed up to 24 months post-treatment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Local failure rate
Secondary outcome measures
Acute radiation toxicity
Late radiation toxicity
Overall survival
+1 more

Side effects data

From 2014 Phase 4 trial • 45 Patients • NCT02000531
29%
Nausea
19%
Leukopenia
14%
Anaemia
14%
Neutropenia
14%
Thrombocytopenia
14%
Alanine aminotransferase increased
14%
Vomiting
14%
White blood cell count decreased
10%
Platelet count decreased
10%
Aspartate aminotransferase increased
10%
Neutrophil count decreased
5%
Diarrhea
5%
Musculoskeletal pain
5%
Dizziness
5%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erlotinib-Chemotherapy
Chemotherapy-Erlotinib

DARTS Trial Design

1Treatment groups
Experimental Treatment
Group I: Dose-escalated adaptive chemoradiotherapyExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemotherapy
2003
Completed Phase 4
~3050

Find a Location

Who is running the clinical trial?

AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
36,181 Total Patients Enrolled
Yee Don, MDPrincipal InvestigatorCross Cancer Institute, Alberta Health Services

Media Library

Chemotherapy (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04952480 — Phase 2
Small Cell Lung Cancer Research Study Groups: Dose-escalated adaptive chemoradiotherapy
Small Cell Lung Cancer Clinical Trial 2023: Chemotherapy Highlights & Side Effects. Trial Name: NCT04952480 — Phase 2
Chemotherapy (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04952480 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the utilization of Chemotherapy authorized by the FDA?

"The safety rating of chemotherapy is 2, as there is currently no clinical evidence demonstrating its efficacy but some data that suggests it might be safe."

Answered by AI

Is this experiment available to enrollees at present?

"Affirmative. Clinicaltrials.gov data indicates that this investigation is at present enrolling participants, with a first post date of April 25th 2022 and an update on the same day. The team aims to register 31 individuals from one centre for their research."

Answered by AI

What is the currenct capacity for participants in this experiment?

"Indeed, the clinicaltrials.gov page states that this trial is currently recruiting volunteers. The study was made public on April 25th 2022 and has since been subject to regular updates. A total of 31 individuals between 1 sites are needed for full enrolment."

Answered by AI
~15 spots leftby Nov 2025