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Pulsed Low Dose Rate Radiation With Concurrent Chemotherapy for Non-Small Cell Lung Cancer and Esophageal Cancer

Primary Purpose

Lung Cancer, Esophageal Cancer

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Pulsed Low Dose Radiation

Carboplatin

Paclitaxel

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

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

Inclusion Criteria:

Patient must have pathologically-confirmed and previously untreated:
- Non-small cell lung cancer, Stage IIIA (T1-3 N2 M0); OR
- Localized esophageal cancer, ≥T2, or N+, and M0 according to the American Joint Committee on Cancer (AJCC) 7th edition staging.
The planned treatment regimen must be concurrent chemoradiation with Carboplatin-Paclitaxel followed by surgery.
Age > 18 years.
Eastern Cooperative Oncology Group (ECOG) performance status is 0-1.
Laboratory studies must meet each of the following criteria (with labs drawn within 4 weeks prior to the registration):
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- Platelets ≥100,000 cells/mm3
- Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable)
- Creatinine ≤2 X the upper limit of normal
- Bilirubin ≤ 1.5 X upper limit of normal
- Aspartate transaminase (AST) ≤ 3 X upper limit of normal
Men and women of childbearing potential must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy completed.
Patients must be able to read and write English to comply with the questionnaire portions of the protocol.
Subjects must sign a written informed study consent and HIPAA consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up.

Exclusion Criteria:

Patients who have had previous radiotherapy in the thorax.
Patients who have a history of ataxia telangiectasia or other documented history of radiation hypersensitivity.
Patients who have a history scleroderma or other active connective tissue disease.
Women of childbearing potential must not be pregnant with a negative urine pregnancy test within 72 hours prior to registration and non-lactating; postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential; woman status post oophorectomy or hysterectomy are considered non-childbearing potential
Patients who have uncontrolled inter-current illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements.

Sites / Locations

Fox Chase Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pulsed Low dose radiation with Carboplatin/Paclitaxel

Arm Description

Pulsed Low Dose Radiation concurrent with Carboplatin and Paclitaxel

Outcomes

Primary Outcome Measures

Rate of severe acute esophagitis in patients with lung cancer and esophageal cancer treated with concurrent CRT using PLDR technique.

The investigator will evaluate the severity of other adverse events using the NCI Common Terminology Criteria for Adverse Events (CTCAE v.4.0).

Secondary Outcome Measures

Quality of life

Quality of life will be evaluated based on a quality of life survey conducted at different time-points during the study. After entering in the study survey will be conducted in 1st month , 2nd month ,3rd month, 6th month, 9th month. Number of surveys conducted will be the same however a delay due toxicity is possible and therefore last survey could be collected up to 12 months.

Progression free survival

progression free survival will be evaluated from the day of first treatment until disease progression

Response rate based

Response rate will be evaluated based on the outcome of surgical pathology

Full Information

NCT ID

NCT03094884

First Posted

March 23, 2017

Last Updated

May 22, 2023

Sponsor

Fox Chase Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT03094884

Brief Title

Pulsed Low Dose Rate Radiation With Concurrent Chemotherapy for Non-Small Cell Lung Cancer and Esophageal Cancer

Official Title

Pulsed Low Dose Rate Radiation With Concurrent Chemotherapy for Non-Small Cell Lung Cancer and Esophageal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 24, 2017 (Actual)

Primary Completion Date

May 1, 2024 (Anticipated)

Study Completion Date

May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fox Chase Cancer Center

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

Yes

5. Study Description

Brief Summary

Phase I study with the hypothesis that Pulsed Low Dose Radiation (PLDR) radiation delivery technique can significantly decrease the rate of severe acute esophagitis in patients receiving concurrent Chemo-radiation therapy (CRT) for non-small cell lung cancer or esophageal cancer while maintaining similar efficacy. For these patients, the rate of severe acute esophagitis during concurrent CRT is high (approximately 20%) when conventional external beam radiation is utilized. Severe acute esophagitis can cause many adverse consequences such as severe discomfort, weight loss, hospitalization, interruption/early termination of treatment, and worse surgical complications for those who receive surgery after CRT. PLDR radiation has the potential to maintain the tumor control rates of conventional radiation while decreasing the toxicity to the surrounding normal tissue 29-35. We have completed accrual to a phase I PLDR radiation study, in which patient received palliative re-irradiation with PLDR technique for their metastatic disease in previous irradiated field. In that phase I study, PLDR demonstrated safety for acute toxicities in the setting of re-irradiation for a total dose of 50 Gy, with analysis of 60 Gy pending. The follow up time for that phase I study is limited as most enrolled patients have short overall survival due to their terminal illness. This proposed phase I study is, to our knowledge, the first clinical study with combination of PLDR radiation and concurrent chemotherapy for definitive treatment.

6. Conditions and Keywords

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

Lung Cancer, Esophageal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pulsed Low dose radiation with Carboplatin/Paclitaxel

Arm Type

Experimental

Arm Description

Pulsed Low Dose Radiation concurrent with Carboplatin and Paclitaxel

Intervention Type

Radiation

Intervention Name(s)

Pulsed Low Dose Radiation

Intervention Description

Treatment naïve patients with non-small cell lung cancer or esophageal cancer whose planned treatment regimen is concurrent CRT followed by surgery. The total radiation dose will be 50.4 Gy in daily fraction of 1.8 Gy for esophageal cancer and 60 Gy in daily fraction of 2 Gy for non-small cell lung cancer. The concurrent chemo regimen will carboplatin-paclitaxel managed by the treating medical oncologist. Patients are planned to receive surgery at approximately 6 to 9 weeks after finishing CRT with surgical aspects determined by the treating surgical oncologist.

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

Primary Outcome Measure Information:

Title

Rate of severe acute esophagitis in patients with lung cancer and esophageal cancer treated with concurrent CRT using PLDR technique.

Description

The investigator will evaluate the severity of other adverse events using the NCI Common Terminology Criteria for Adverse Events (CTCAE v.4.0).

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Quality of life

Description

Time Frame

1 year

Title

Progression free survival

Description

progression free survival will be evaluated from the day of first treatment until disease progression

Time Frame

1-5 years

Title

Response rate based

Description

Response rate will be evaluated based on the outcome of surgical pathology

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient must have pathologically-confirmed and previously untreated: Non-small cell lung cancer, Stage IIIA (T1-3 N2 M0); OR Localized esophageal cancer, ≥T2, or N+, and M0 according to the American Joint Committee on Cancer (AJCC) 7th edition staging. The planned treatment regimen must be concurrent chemoradiation with Carboplatin-Paclitaxel followed by surgery. Age > 18 years. Eastern Cooperative Oncology Group (ECOG) performance status is 0-1. Laboratory studies must meet each of the following criteria (with labs drawn within 4 weeks prior to the registration): Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3 Platelets ≥100,000 cells/mm3 Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable) Creatinine ≤2 X the upper limit of normal Bilirubin ≤ 1.5 X upper limit of normal Aspartate transaminase (AST) ≤ 3 X upper limit of normal Men and women of childbearing potential must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy completed. Patients must be able to read and write English to comply with the questionnaire portions of the protocol. Subjects must sign a written informed study consent and HIPAA consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up. Exclusion Criteria: Patients who have had previous radiotherapy in the thorax. Patients who have a history of ataxia telangiectasia or other documented history of radiation hypersensitivity. Patients who have a history scleroderma or other active connective tissue disease. Women of childbearing potential must not be pregnant with a negative urine pregnancy test within 72 hours prior to registration and non-lactating; postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential; woman status post oophorectomy or hysterectomy are considered non-childbearing potential Patients who have uncontrolled inter-current illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements.

Central Contact Person:

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

Joshua Meyer, MD

Phone

215-214-1515

joshua.meyer@fccc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joshua Meyer, MD

Organizational Affiliation

Fox Chase Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fox Chase Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joshua Meyer, MD

Phone

215-214-1515

joshua.meyer@fccc.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Pulsed Low Dose Rate Radiation With Concurrent Chemotherapy for Non-Small Cell Lung Cancer and Esophageal Cancer

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