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Assessing the Efficacy and Safety of Selective Metabolically Adaptive Radiation Dose Escalation in Locally Advanced Non-Small Cell Lung Cancer Receiving Definitive Chemoradiotherapy (PET-BOOST)

Primary Purpose

Non-Small Cell Lung Cancer

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Chemoradiotherapy

Chemoradiotherapy with Integrated Boost Dose

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

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

Inclusion Criteria:

Patients who are at least 18 years old and are able to consent
Patients who will undergo Chemo-RT as primarily modality of treatment
Patients with a primary tumor or node measuring at least 10mm on CT scan
Patients with a PET avid tumor having Standardized Uptake Values (SUV) > 4
Patients with Eastern Cooperative Oncology Group (ECOG) status 0-2 within 4 weeks of randomization

Exclusion Criteria:

Trimodality patients who have surgery as part of curative treatment
Previous radiotherapy to intended treatment volumes
Active invasive malignancy other than lung cancer
Active pregnancy
Poor respiratory function (Forced Expiratory Volume < 1.0 or Diffusing Capacity < 50% age-adjusted normal)
ECOG status > 2
Pre-treatment complete blood count/differential showing inadequate bone marrow reserve (absolute neutrophil count < 1800 cells/mm3 or platelets < 100 000 cells/mm3 or hemoglobin < 90g/L), measured within 4 weeks of registration
AST, ALT or total bilirubin > 2.5 times the upper limit of normal, measured within 4 weeks of registration
Unintentional weight loss >10% over 3 months within 4 weeks of registration
Severe active co-morbidity defined by:
Significant history of uncontrolled cardiac disease; i.e. uncontrolled hypertension, unstable angina, myocardial infarction within the last 6 months, uncontrolled congestive heart failure, cardiomyopathy with decreased ejection fraction
Transmural myocardial infection requiring intravenous antibiotics at the time of registration
Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before randomization
Acquired immune deficiency syndrome (AIDS) based on the current Centre for Disease Control definition; note, however, that HIV testing is not required for entry into this protocol

Sites / Locations

London Regional Cancer ProgramRecruiting
Stronach Regional Cancer Centre at Southlake Regional Health CentreRecruiting
Princess Margaret Cancer CentreRecruiting
Kingston General HospitalRecruiting
McGill University Health Centre, Glen site Cedars Cancer CenterRecruiting
CHUS - Hôpital FleurimontRecruiting
CHU de Quebec - L'Hôtel-Dieu de QuébecRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Chemoradiotherapy

Chemoradiotherapy with Integrated Boost Dose

Arm Description

Patients randomized to the standard arm will receive radiotherapy (5x per week) of 60 gray (Gy) in 30 fractions with concurrent cisplatin and etoposide chemotherapy.

Patients randomized to the experimental arm will receive radiotherapy (5x per week) with an integrated boost dose of up to 85Gy in 30 fractions to tumor subvolumes, with concurrent cisplatin and etoposide chemotherapy.

Outcomes

Primary Outcome Measures

Reduction of local-regional failure rate

Primary outcome of the trial is to determine if dose escalation to metabolically active subvolumes will reduce local-regional failure rate

Secondary Outcome Measures

Progression-Free Survival

Determine if dose escalation to metabolically active subvolumes will improve progression-free survival at 2 years

Overall Survival

Determine if dose escalation to metabolically active subvolumes will improve overall survival at 2 years

Grade 3-5 Toxicity Rate

Determine if dose escalation to metabolically active subvolumes will increase the rate of grade 3-5 toxicities

Quality of Life FACT-L

Compare the quality of life in the two arms using Functional Assessment of Cancer Therapy-Lung (FACT-L) instrument

Quality of Life EQ-5D

Compare the quality of life in the two arms using EuroQol Quality of Life-5 Dimensions (EQ-5D) instrument

Dose-Response Characterization

Characterize the tumor dose-response relationship in the experimental arm and create a tumor control probability model for local-regional failure at 2 years

Dose Escalation Feasibility

Explore the feasibility of adaptive dose escalation based on PET response at week 2

Imaging Use

Explore the use of Week 0 and Week 2 PET images for prognostication and response assessment for local-regional failure at 2 years

Full Information

NCT ID

NCT02788461

First Posted

April 28, 2016

Last Updated

April 7, 2022

Sponsor

Lawson Health Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT02788461

Brief Title

Assessing the Efficacy and Safety of Selective Metabolically Adaptive Radiation Dose Escalation in Locally Advanced Non-Small Cell Lung Cancer Receiving Definitive Chemoradiotherapy

Acronym

PET-BOOST

Official Title

A Randomized Phase II Trial to Assess the Efficacy and Safety of Selective Metabolically Adaptive Radiation Dose Escalation in Locally Advanced Non-Small Cell Lung Cancer Receiving Definitive Chemoradiotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 2016 (undefined)

Primary Completion Date

April 2025 (Anticipated)

Study Completion Date

April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lawson Health Research Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A randomized phase II trial to assess the efficacy and safety of selective metabolically adaptive radiation dose escalation in locally advanced non-small cell lung cancer receiving definitive chemoradiotherapy. Eligible and consenting patients will be randomized to receive conventional chemoradiotherapy or chemoradiotherapy with a radiation (RT) integrated boost. All patients will receive a fludeoxyglucose-positron emission tomography (FDG-PET) scan within two weeks prior to starting treatment. The primary outcome is to determine if dose escalation to metabolically active tumor subvolumes will reduce local-regional failure rate at 2 years.

6. Conditions and Keywords

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

Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Chemoradiotherapy

Arm Type

Active Comparator

Arm Description

Patients randomized to the standard arm will receive radiotherapy (5x per week) of 60 gray (Gy) in 30 fractions with concurrent cisplatin and etoposide chemotherapy.

Arm Title

Chemoradiotherapy with Integrated Boost Dose

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Chemoradiotherapy

Intervention Description

Patients will receive radiotherapy of 60Gy in 30 fractions (5x per week) with concurrent cisplatin and etoposide chemotherapy.

Intervention Type

Radiation

Intervention Name(s)

Chemoradiotherapy with Integrated Boost Dose

Intervention Description

Patients will receive an RT integrated boost to tumor subvolumes (max boost dose of 85Gy) in 30 fractions (5x per week) with concurrent cisplatin and etoposide chemotherapy.

Primary Outcome Measure Information:

Title

Reduction of local-regional failure rate

Description

Primary outcome of the trial is to determine if dose escalation to metabolically active subvolumes will reduce local-regional failure rate

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Progression-Free Survival

Description

Determine if dose escalation to metabolically active subvolumes will improve progression-free survival at 2 years

Time Frame

2 years

Title

Overall Survival

Description

Determine if dose escalation to metabolically active subvolumes will improve overall survival at 2 years

Time Frame

2 years

Title

Grade 3-5 Toxicity Rate

Description

Determine if dose escalation to metabolically active subvolumes will increase the rate of grade 3-5 toxicities

Time Frame

2 years

Title

Quality of Life FACT-L

Description

Compare the quality of life in the two arms using Functional Assessment of Cancer Therapy-Lung (FACT-L) instrument

Time Frame

2 years

Title

Quality of Life EQ-5D

Description

Compare the quality of life in the two arms using EuroQol Quality of Life-5 Dimensions (EQ-5D) instrument

Time Frame

2 years

Title

Dose-Response Characterization

Description

Characterize the tumor dose-response relationship in the experimental arm and create a tumor control probability model for local-regional failure at 2 years

Time Frame

2 years

Title

Dose Escalation Feasibility

Description

Explore the feasibility of adaptive dose escalation based on PET response at week 2

Time Frame

2 weeks

Title

Imaging Use

Description

Explore the use of Week 0 and Week 2 PET images for prognostication and response assessment for local-regional failure at 2 years

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients who are at least 18 years old and are able to consent Patients who will undergo Chemo-RT as primarily modality of treatment Patients with a primary tumor or node measuring at least 10mm on CT scan Patients with a PET avid tumor having Standardized Uptake Values (SUV) > 4 Patients with Eastern Cooperative Oncology Group (ECOG) status 0-2 within 4 weeks of randomization Exclusion Criteria: Trimodality patients who have surgery as part of curative treatment Previous radiotherapy to intended treatment volumes Active invasive malignancy other than lung cancer Active pregnancy Poor respiratory function (Forced Expiratory Volume < 1.0 or Diffusing Capacity < 50% age-adjusted normal) ECOG status > 2 Pre-treatment complete blood count/differential showing inadequate bone marrow reserve (absolute neutrophil count < 1800 cells/mm3 or platelets < 100 000 cells/mm3 or hemoglobin < 90g/L), measured within 4 weeks of registration AST, ALT or total bilirubin > 2.5 times the upper limit of normal, measured within 4 weeks of registration Unintentional weight loss >10% over 3 months within 4 weeks of registration Severe active co-morbidity defined by: Significant history of uncontrolled cardiac disease; i.e. uncontrolled hypertension, unstable angina, myocardial infarction within the last 6 months, uncontrolled congestive heart failure, cardiomyopathy with decreased ejection fraction Transmural myocardial infection requiring intravenous antibiotics at the time of registration Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before randomization Acquired immune deficiency syndrome (AIDS) based on the current Centre for Disease Control definition; note, however, that HIV testing is not required for entry into this protocol

Central Contact Person:

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

Alex Sun, MD, FRCPC

Phone

416 946 4545

alex.sun@rmp.uhn.on.ca

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

David Palma, MD, FRCPC

Phone

519-685-8500

david.palma@lhsc.on.ca

Facility Information:

Facility Name

London Regional Cancer Program

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4L6

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Palma, MD

Phone

519-685-8500

david.palma@lhsc.on.ca

Facility Name

Stronach Regional Cancer Centre at Southlake Regional Health Centre

City

Newmarket,

State/Province

Ontario

ZIP/Postal Code

L3Y 2P9

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mojgan Taremi, MD, FRCPC

Phone

905-895-4521

Ext

6595

mtaremi@southlakeregional.org

Facility Name

Princess Margaret Cancer Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alex Sun, MD, FRCPC

Phone

(416) 946-2000

alex.sun@rmp.uhn.on.ca

Facility Name

Kingston General Hospital

City

Kingston

State/Province

Ont

ZIP/Postal Code

K7L 2V7

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Allison Ashworth, MD, FRCPC

Phone

613-544-2631

Ext

8106

allison.ashworth@krcc.on.ca

Facility Name

McGill University Health Centre, Glen site Cedars Cancer Center

City

Montreal,

State/Province

Quebec

ZIP/Postal Code

H4A 3J1

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sergio L. Faria, MD, PhD

Phone

(514) 934-1934

Ext

36157

First Name & Middle Initial & Last Name & Degree

Marianna Perna

Phone

(514) 934-1934

Ext

43191

marianna.perna@muhc.mcgill.ca

Facility Name

CHUS - Hôpital Fleurimont

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sophie Couture

Phone

819-346-1110

Ext

14311

socouture.chus@ssss.gouv.qc.ca

First Name & Middle Initial & Last Name & Degree

Cynthia Ladouceur

Phone

819-346-11101

Ext

13250

cynthia.ladouceur.ciussse.chus@ssss.gouv.qc.ca

First Name & Middle Initial & Last Name & Degree

Marc É Plourde, FRCPC

First Name & Middle Initial & Last Name & Degree

Myriam Bouchard, FRCPC

First Name & Middle Initial & Last Name & Degree

Guy A Turgeon, FRCPC

Facility Name

CHU de Quebec - L'Hôtel-Dieu de Québec

City

Quebec

ZIP/Postal Code

G2L 2Z3

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anne Dagnault, MD PhD

Phone

1 418-525-4444,

Ext

15264

anne.dagnault@mail.chuq.qc.ca

First Name & Middle Initial & Last Name & Degree

Josee Allard;

Phone

(418) 525-4444

Ext

16730

Josee.Allard@chudequebec.ca

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29903551

Citation

Raman S, Bissonnette JP, Warner A, Le L, Bratman S, Leighl N, Bezjak A, Palma D, Schellenberg D, Sun A. Rationale and Protocol for a Canadian Multicenter Phase II Randomized Trial Assessing Selective Metabolically Adaptive Radiation Dose Escalation in Locally Advanced Non-small-cell Lung Cancer (NCT02788461). Clin Lung Cancer. 2018 Sep;19(5):e699-e703. doi: 10.1016/j.cllc.2018.05.002. Epub 2018 May 16.

Results Reference

derived

Learn more about this trial

Assessing the Efficacy and Safety of Selective Metabolically Adaptive Radiation Dose Escalation in Locally Advanced Non-Small Cell Lung Cancer Receiving Definitive Chemoradiotherapy

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