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Hypofractionated Radiotherapy With Carboplatin and Paclitaxel in Non-Small Cell Lung Cancer

Primary Purpose

Non Small Cell Lung Cancer

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

2.5 Gy/fraction

Carboplatin

Paclitaxel

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Radiation, NSCLC, Hypofractionated, Carboplatin, Paclitaxel, IMRT, Fraction, Stage III, 4D PET/CT

Eligibility Criteria

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

Inclusion Criteria:

Pathologically proven diagnosis of Stage IIIA or IIIB non-small cell lung cancer (NSCLC).
Stage IIIA subjects who are considered eligible for resection following neoadjuvant chemoradiation are eligible for this study.
No PET/CT evidence of metastatic disease.
An MRI of the brain with contrast excluding intracranial metastatic disease (or CT with contrast if MRI is medically contraindicated). An MRI without contrast is only permitted if the subject cannot have contrast for medical reasons.
If a pleural effusion is present, it must be tapped and confirmed to be cytologically negative. If an effusion is deemed too small to safely tap, the subject will be eligible.
Subjects must have measurable or evaluable disease.
No prior thoracic radiotherapy.
Age > 18 years at time of registration.
ECOG Performance Status of 0-2 (Karnofsky performance scale ≥ 60).
Hgb > 9 g/dL; ANC (absolute neutrophil count) > 1500/µl; platelets > 100,000 mcL.
Subjects must sign study-specific informed consent form prior to registration.
Radiation therapy and chemotherapy must start within 4 weeks of study enrollment.

Exclusion Criteria:

Evidence of severe or uncontrolled psychiatric or systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) that would interfere with study protocol as judged by the investigator.
Active connective tissue disorders, such as active lupus or scleroderma.
Known Acquired Immune Deficiency (HIV (+)/AIDS).
Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regiment to harm nursing infants. Women of childbearing potential must agree to use medically approved and adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

Sites / Locations

University of Toledo, Eleanor N. Dana Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiation

Arm Description

2.5 Gy/Fraction

Outcomes

Primary Outcome Measures

Acute and late toxicities assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv5.0)

Acute toxicities (toxicity during and within 90 days of radiation therapy) and delayed toxicities will be measured using CTCAE criteria, version 5.0. Acute toxicities are defined as those toxicities occurring during and within 90 days from the completion of radiotherapy and delayed toxicities are those that develop at least 90 days after the last dose of radiation

Secondary Outcome Measures

Progression-free survival

Progression-free survival will be measured from the last day of radiation treatment until evidence of local or distant disease progression.

Overall Survival

Overall survival will be measured from the last day of radiation treatment until death.

Local control

Assessment of local control after treatment with radiotherapy combined with Carboplatin and Placlitaxel

Full Information

NCT ID

NCT03699033

First Posted

October 3, 2018

Last Updated

November 3, 2020

Sponsor

Stephanie Smiddy

1. Study Identification

Unique Protocol Identification Number

NCT03699033

Brief Title

Hypofractionated Radiotherapy With Carboplatin and Paclitaxel in Non-Small Cell Lung Cancer

Official Title

A Phase II Trial of Hypofractionated Intensity-Modulated Radiation Therapy (IMRT) Utilizing 2.5 Gy/Fraction to PET-avid Disease Combined With Carboplatin and Paclitaxel for Subjects With Stage IIIA or IIIB Non-Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Withdrawn

Why Stopped

No patients available

Study Start Date

October 1, 2018 (Actual)

Primary Completion Date

October 1, 2020 (Actual)

Study Completion Date

October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Stephanie Smiddy

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Single center, single arm, Phase II study designed to evaluate the feasibility of hypofractionated IMRT to 62.5 Gy in 25 fractions (2.5 Gy/fraction) with 4D PET/CT-based radiation treatment planning and concurrent carboplatin and paclitaxel in Stage IIIA or Stage IIIB NSCLC subjects.

Detailed Description

This study is designed to evaluate the feasibility of hypofractionated IMRT to 62.5 Gy in 25 fractions (2.5 Gy/fraction) with 4D PET/CT-based radiation treatment planning and concurrent carboplatin and paclitaxel in Stage IIIA or Stage IIIB NSCLC subjects. Hypofractionated IMRT allows escalation of the biological effective dose (BED) to the tumor and reduces the radiation treatment duration to 5 weeks. Increasing the BED without protracting the RT course may be a more effective means of dose escalation than simply increasing the total dose but using only 2 Gy/fraction, as was tested in RTOG 0617. Investigators require the use of advanced treatment planning techniques, including 4D CT simulation, volume delineation utilizing PET/CT to identify gross disease and IMRT to minimize the total volume of normal tissue receiving a high dose of radiation. As minimal published work has evaluated hypofractionated RT regimens for Stage III NSCLC with concurrent chemotherapy, investigators selected a moderately escalated dose/fraction of 2.5 Gy for evaluation in combination with concurrent carboplatin and paclitaxel.

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

Radiation, NSCLC, Hypofractionated, Carboplatin, Paclitaxel, IMRT, Fraction, Stage III, 4D PET/CT

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Radiation

Arm Type

Experimental

Arm Description

2.5 Gy/Fraction

Intervention Type

Radiation

Intervention Name(s)

2.5 Gy/fraction

Intervention Description

Hypofractionated Intensity-Modulated Radiation Therapy (IMRT) Utilizing 2.5 Gy/Fraction to PET-avid Disease Combined with Carboplatin and Paclitaxel

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Description

The doses of chemotherapy to be given concurrently with conformal radiotherapy will be weekly paclitaxel (45 mg/m2) and carboplatin (AUC=2), respectively. Consolidation chemotherapy with 2 cycles of carboplatin (AUC=6) and paclitaxel (200 mg/m2) should be administered following completion of concurrent chemoradiation.

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

Primary Outcome Measure Information:

Title

Acute and late toxicities assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv5.0)

Description

Time Frame

During and within 90 days of radiation therapy

Secondary Outcome Measure Information:

Title

Progression-free survival

Description

Progression-free survival will be measured from the last day of radiation treatment until evidence of local or distant disease progression.

Time Frame

year 0 - year 2

Title

Overall Survival

Description

Overall survival will be measured from the last day of radiation treatment until death.

Time Frame

year 0 - year 5

Title

Local control

Description

Assessment of local control after treatment with radiotherapy combined with Carboplatin and Placlitaxel

Time Frame

year 0 - year 2

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pathologically proven diagnosis of Stage IIIA or IIIB non-small cell lung cancer (NSCLC). Stage IIIA subjects who are considered eligible for resection following neoadjuvant chemoradiation are eligible for this study. No PET/CT evidence of metastatic disease. An MRI of the brain with contrast excluding intracranial metastatic disease (or CT with contrast if MRI is medically contraindicated). An MRI without contrast is only permitted if the subject cannot have contrast for medical reasons. If a pleural effusion is present, it must be tapped and confirmed to be cytologically negative. If an effusion is deemed too small to safely tap, the subject will be eligible. Subjects must have measurable or evaluable disease. No prior thoracic radiotherapy. Age > 18 years at time of registration. ECOG Performance Status of 0-2 (Karnofsky performance scale ≥ 60). Hgb > 9 g/dL; ANC (absolute neutrophil count) > 1500/µl; platelets > 100,000 mcL. Subjects must sign study-specific informed consent form prior to registration. Radiation therapy and chemotherapy must start within 4 weeks of study enrollment. Exclusion Criteria: Evidence of severe or uncontrolled psychiatric or systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) that would interfere with study protocol as judged by the investigator. Active connective tissue disorders, such as active lupus or scleroderma. Known Acquired Immune Deficiency (HIV (+)/AIDS). Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regiment to harm nursing infants. Women of childbearing potential must agree to use medically approved and adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

Facility Information:

Facility Name

University of Toledo, Eleanor N. Dana Cancer Center

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43614

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Hypofractionated Radiotherapy With Carboplatin and Paclitaxel in Non-Small Cell Lung Cancer

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