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Radiation Therapy to Relieve Symptoms in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Primary Purpose

Non-Small Cell Lung Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cyclical Hypofractionated Palliative Radiation (Quad Shot)
EORTC QLQ-C30 questionnaire
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Cyclical Hypofractionated Palliative Radiation (Quad Shot, 20-148

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically confirmed non-small cell lung cancer with metastatic disease detected on cross-sectional imaging with a plan for one of the following systemic therapies:

    • Carboplatin/paclitaxel
    • Carboplatin/paclitaxel/pembrolizumab
    • Carboplatin/pemetrexed
    • Carboplatin/pemetrexed/pembrolizumab
    • Pembrolizumab (single agent or in combination with other regimens in this list)
    • Cisplatin/pemetrexed
    • Cisplatin/pemetrexed/pembrolizumab
    • Pemetrexed/pembrolizumab
    • Pemetrexed
    • Nivolumab (single agent or in combination with other regimens in this list)
    • Ipilimumab/nivolumab
    • Carboplatin/etoposide
    • Carboplatin/etoposide/atezolizumab
    • Cisplatin/etoposide
    • Cisplatin/etoposide/atezolizumab
    • Durvalumab (single agent or in combination with other regimens in this list)
    • Atezolizumab (single agent or in combination with other regimens in this list)
  • Patients eligible for the systemic therapy regimens notes
  • Patients with Stage IV NSCLC who have symptomatic (defined by patient-reported cough, dyspnea, or hemoptysis) or near-symptomatic (determined radiographically to be threatening the airway, esophagus or vasculature) centrally located.
  • KPS ≥ 60
  • Age ≥ 18 years.
  • Able to provide informed consent.
  • Patients at reproductive potential must agree to practice an effective contraceptive method.

Exclusion Criteria:

  • Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
  • Serious medical co-morbidities precluding radiotherapy.
  • Pregnant or breast-feeding women.

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Monmouth (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Bergen (All protocol activities)Recruiting
  • Memorial Sloan Kettering Commack (All protocol activities)Recruiting
  • Memorial Sloan Kettering Westchester (All protocol activities)Recruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Memorial Sloan Kettering Nassau (All protocol activities)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Quad Shot Radiation

Arm Description

In this trial, patients with centrally located lung tumors will be treated with up to 3 cycles of Quad Shot Radiation. Radiation treatment will be given within 1 week of administration of chemotherapy. Quad Shot radiation will involve: 3.7 Gy twice daily x 2 days for a total dose of 14.8 Gy per cycle. The next cycle will occur after a 21-28 day break. The first group of patients will be treated with 2 cycles of quad shot radiation, followed by a 3-month observation period post-RT to allow a complete evaluation of acute toxicity. The next group of patients will be treated with either 1 cycle or 3 cycles of quad shot radiation. The minimum accrual is 4 patients with an expected accrual of 16 patients. Twenty additional patients will be recruited to an expansion cohort.

Outcomes

Primary Outcome Measures

Dose Limiting Toxicity
Dose Limiting Toxicity will be defined by CTCAE v5 grade 3 or higher for Esophagitis, Pneumonitis, Bronchial, bronchopleural or tracheal fistula, Bronchopulmonary or mediastinal hemorrhage. Patients will be evaluable for AE/DLTs from the start of study therapy through the end of the 3-month observation period

Secondary Outcome Measures

number of patients who are able to complete the assigned radiation therapy regimen (1, 2, or 3 cycles of quad shot)
Feasibility will be determined by the number of patients who are able to complete the assigned radiation therapy regimen (1, 2, or 3 cycles of quad shot) over the number of patients who start the assigned radiation therapy regimen.

Full Information

First Posted
May 8, 2020
Last Updated
March 7, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04384146
Brief Title
Radiation Therapy to Relieve Symptoms in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Official Title
PROMISE 006: A Phase I Study of up to 3 Cycles of Cyclical Hypofractionated Palliative Radiation (Quad Shot) for Lung Tumors in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 7, 2020 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief Summary
This study will test the safety of Quad Shot radiation therapy using 2 different treatment schedules to find out what effects, if any, this treatment has on people with advanced NSCLC who are receiving systemic therapy for their cancer. The Quad Shot treatment schedule reduces the number of days needed to deliver the radiation treatments, which may be less disruptive to systemic therapy schedules.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Cyclical Hypofractionated Palliative Radiation (Quad Shot, 20-148

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Phase I, prospective trial.
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Quad Shot Radiation
Arm Type
Experimental
Arm Description
In this trial, patients with centrally located lung tumors will be treated with up to 3 cycles of Quad Shot Radiation. Radiation treatment will be given within 1 week of administration of chemotherapy. Quad Shot radiation will involve: 3.7 Gy twice daily x 2 days for a total dose of 14.8 Gy per cycle. The next cycle will occur after a 21-28 day break. The first group of patients will be treated with 2 cycles of quad shot radiation, followed by a 3-month observation period post-RT to allow a complete evaluation of acute toxicity. The next group of patients will be treated with either 1 cycle or 3 cycles of quad shot radiation. The minimum accrual is 4 patients with an expected accrual of 16 patients. Twenty additional patients will be recruited to an expansion cohort.
Intervention Type
Radiation
Intervention Name(s)
Cyclical Hypofractionated Palliative Radiation (Quad Shot)
Intervention Description
3.7 Gy twice daily x 2 days for a total dose of 14.8 Gy per cycle. The next cycle will occur after a 21-28 day break.
Intervention Type
Behavioral
Intervention Name(s)
EORTC QLQ-C30 questionnaire
Intervention Description
at baseline, each cycle of Quad Shot, and at 3 weeks, 3 months and 6 months after last cycle of Quad Shot.
Primary Outcome Measure Information:
Title
Dose Limiting Toxicity
Description
Dose Limiting Toxicity will be defined by CTCAE v5 grade 3 or higher for Esophagitis, Pneumonitis, Bronchial, bronchopleural or tracheal fistula, Bronchopulmonary or mediastinal hemorrhage. Patients will be evaluable for AE/DLTs from the start of study therapy through the end of the 3-month observation period
Time Frame
3 months
Secondary Outcome Measure Information:
Title
number of patients who are able to complete the assigned radiation therapy regimen (1, 2, or 3 cycles of quad shot)
Description
Feasibility will be determined by the number of patients who are able to complete the assigned radiation therapy regimen (1, 2, or 3 cycles of quad shot) over the number of patients who start the assigned radiation therapy regimen.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed non-small cell lung cancer with metastatic disease detected on cross-sectional imaging with a plan for one of the following systemic therapies: Carboplatin/paclitaxel Carboplatin/paclitaxel/pembrolizumab Carboplatin/pemetrexed Carboplatin/pemetrexed/pembrolizumab Pembrolizumab (single agent or in combination with other regimens in this list) Cisplatin/pemetrexed Cisplatin/pemetrexed/pembrolizumab Pemetrexed/pembrolizumab Pemetrexed Nivolumab (single agent or in combination with other regimens in this list) Ipilimumab/nivolumab Carboplatin/etoposide Carboplatin/etoposide/atezolizumab Cisplatin/etoposide Cisplatin/etoposide/atezolizumab Durvalumab (single agent or in combination with other regimens in this list) Atezolizumab (single agent or in combination with other regimens in this list) Patients eligible for the systemic therapy regimens notes Patients with Stage IV NSCLC who have symptomatic (defined by patient-reported cough, dyspnea, or hemoptysis) or near-symptomatic (determined radiographically to be threatening the airway, esophagus or vasculature) centrally located. KPS ≥ 60 Age ≥ 18 years. Able to provide informed consent. Patients at reproductive potential must agree to practice an effective contraceptive method. Exclusion Criteria: Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances. Serious medical co-morbidities precluding radiotherapy. Pregnant or breast-feeding women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annemarie Shepherd, MD
Phone
908-542-3430
Email
shephera@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Afsheen Iqbal, MD
Phone
908-542-3383
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annemarie Shepherd, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annemarie Shepherd, MD
Phone
908-542-3430
Facility Name
Memorial Sloan Kettering Monmouth (All Protocol Activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annemarie Shepherd, MD
Phone
908-542-3430
Facility Name
Memorial Sloan Kettering Bergen (All protocol activities)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annemarie Shepherd, MD
Phone
908-542-3430
Facility Name
Memorial Sloan Kettering Commack (All protocol activities)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annemarie Shepherd, MD
Phone
908-542-3430
Facility Name
Memorial Sloan Kettering Westchester (All protocol activities)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annemarie Shepherd, MD
Phone
908-542-3430
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annemarie Shepherd, MD
Phone
908-542-3430
Facility Name
Memorial Sloan Kettering Nassau (All protocol activities)
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annemarie Shepherd, MD
Phone
908-542-3430

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

Radiation Therapy to Relieve Symptoms in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

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