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

Primary Purpose

Small Cell Lung Cancer

Status

Recruiting

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Dose-escalated adaptive radiotherapy

Chemotherapy

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Small cell lung cancer, (Dose-escalated) Adaptive radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cross Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dose-escalated adaptive chemoradiotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Local failure rate

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

Secondary Outcome Measures

Progression-free survival

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

Overall survival

Time from diagnostic biopsy to death of the patient.

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.

Late radiation toxicity

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

Full Information

NCT ID

NCT04952480

First Posted

June 28, 2021

Last Updated

January 17, 2023

Sponsor

AHS Cancer Control Alberta

1. Study Identification

Unique Protocol Identification Number

NCT04952480

Brief Title

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

Acronym

DARTS

Official Title

Dose-escalated Adaptive Radiotherapy of Thoracic Disease for Small Cell Lung Cancer (DARTS): A Prospective Phase II Trial Evaluating Local Control of Adaptive Dose-escalated Radiotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 13, 2022 (Actual)

Primary Completion Date

November 1, 2025 (Anticipated)

Study Completion Date

November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AHS Cancer Control Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small Cell Lung Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dose-escalated adaptive chemoradiotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Dose-escalated adaptive radiotherapy

Intervention Description

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

Drug

Intervention Name(s)

Chemotherapy

Intervention Description

Concurrent standard of care platinum doublet based therapy

Primary Outcome Measure Information:

Title

Local failure rate

Description

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 Outcome Measure Information:

Title

Progression-free survival

Description

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.

Title

Overall survival

Description

Time from diagnostic biopsy to death of the patient.

Time Frame

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

Title

Acute radiation toxicity

Description

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.

Title

Late radiation toxicity

Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yee Don, MD

Phone

780-432-8783

don.yee@ahs.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yee Don, MD

Organizational Affiliation

Cross Cancer Institute, Alberta Health Services

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cross Cancer Institute

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

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

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