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3-Dimensional Conformal Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Recurrent Tumors

Primary Purpose

Unspecified Adult Solid Tumor, Protocol Specific

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

quality-of-life assessment

intensity-modulated radiation therapy

3-dimensional conformal radiation therapy

About this trial

This is an interventional treatment trial for Unspecified Adult Solid Tumor, Protocol Specific

Eligibility Criteria

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

Inclusion Criteria:

Patients must have histologically-confirmed malignancy
Patients must have recurrent or metastatic tumor located within a previously irradiated field
Tumor within the irradiated field is negatively impacting patient's quality of life or threatening catastrophic complication if left untreated as determined by the treating physician
Patient is not a candidate for, or has not demonstrated a significant local response to chemotherapy, biologic, hormonal ,or other therapies
Patient is not a surgical candidate or tumor is not surgically resectable, as documented by surgical oncologist
Information on previous radiation treatment, including total dose and fractionation must be available; additional information including radiation fields and dose-volume-histogram or isodose lines is preferable
Tumor sites eligible for inclusion on this protocol include thorax, abdomen, and pelvis
Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 in the previously irradiated field
Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to radiation simulation, postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential) and nonlactating, and men and women must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy completed
Eastern Cooperative Oncology Group (ECOG) performance status determined to be between 0 and 3
Absolute neutrophil count (ANC) >= 1,500/ul
Platelets (PLT) >= 75,000/ul
Subjects must sign a written informed consent and Health Insurance Portability and Accountability Act (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 chemotherapy or radiotherapy to the reirradiation target within 4 weeks prior to entering the study
Concurrent chemotherapy or biologic therapy
A history of ataxia telangiectasia or other documented history of radiation hypersensitivity
Scleroderma or active connective tissue disease
For abdominal or pelvic irradiation: active inflammatory bowel disease
Serious, active infections requiring treatment with intravenous (IV) antibiotics
Uncontrolled intercurrent illness including, but not limited to, or psychiatric illness/social situations that would limit compliance with study requirements
Reirradiation targets located within the head, neck, or brain are excluded from this study

Sites / Locations

Fox Chase Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (radiation therapy)

Arm Description

Patients undergo 3-dimensional CRT or IMRT QD, 5 days a week for 10-30 days. Treatment continues in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

MTD of reirradiation with the pulsed low dose rate technique

Defined as the dose level closest to, but not over that which is predicted to result in a dose limiting toxicity (DLT) rate of 20%, the target toxicity rate. Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. A DLT is a grade >= 4 acute or grade >= 3 late toxicity of an organ system within the reirradiation field in the following categories: skin or subcutaneous tissues, gastrointestinal, hepatobiliary, nervous system, renal and urinary, reproductive system, vascular, or respiratory, thoracic and mediastinal disorders.

Secondary Outcome Measures

Palliative efficacy in terms of quality of life and pain levels

Assessed using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 15 Palliative (QLQ-C15-PAL) and the Numeric Pain Scale. The mean and standard deviation will be estimated at each time point.

Duration of response

Measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Assessed using the RECIST 1.1 criteria. Estimated using Kaplan-Meier curves.

Time to progression

Assessed using the RECIST 1.1 criteria. Estimated using Kaplan-Meier curves.

Full Information

NCT ID

NCT01470365

First Posted

November 3, 2011

Last Updated

May 6, 2020

Sponsor

Fox Chase Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT01470365

Brief Title

3-Dimensional Conformal Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Recurrent Tumors

Official Title

Phase I Study of Pulsed Low Dose Rate Reirradiation Delivered With 3DCRT/IMRT for Palliation of Recurrent Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

November 3, 2011 (Actual)

Primary Completion Date

August 31, 2015 (Actual)

Study Completion Date

February 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fox Chase Cancer Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This phase I trial studies the side effects and best dose of 3-dimensional conformal radiation therapy (CRT) or intensity-modulated radiation therapy (IMRT) in treating patients with recurrent tumors. Radiation therapy (RT) uses high energy x rays to kill tumor cells. Palliative radiation therapy may help patients with recurrent tumors live more comfortably.

Detailed Description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of reirradiation with the pulsed low dose rate technique. SECONDARY OBJECTIVES: I. To investigate the dosimetric tolerance of normal structures to reirradiation with the pulsed low dose rate technique. II. To determine the palliative efficacy and quality of life in patients treated on this protocol. III. To determine duration of response and time to progression. OUTLINE: This is a dose-escalation study. Patients undergo 3-dimensional CRT or IMRT once daily (QD), 5 days a week for 10-30 days. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every month for 6 months and then every 12 weeks thereafter.

6. Conditions and Keywords

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

Unspecified Adult Solid Tumor, Protocol Specific

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment (radiation therapy)

Arm Type

Experimental

Arm Description

Patients undergo 3-dimensional CRT or IMRT QD, 5 days a week for 10-30 days. Treatment continues in the absence of disease progression or unacceptable toxicity.

Intervention Type

Procedure

Intervention Name(s)

quality-of-life assessment

Other Intervention Name(s)

quality of life assessment

Intervention Description

Ancillary studies

Intervention Type

Radiation

Intervention Name(s)

intensity-modulated radiation therapy

Other Intervention Name(s)

IMRT

Intervention Description

Undergo IMRT

Intervention Type

Radiation

Intervention Name(s)

3-dimensional conformal radiation therapy

Other Intervention Name(s)

3D conformal radiation therapy, 3D-CRT

Intervention Description

Undergo 3-dimensional CRT

Primary Outcome Measure Information:

Title

MTD of reirradiation with the pulsed low dose rate technique

Description

Time Frame

Up to 30 days

Secondary Outcome Measure Information:

Title

Palliative efficacy in terms of quality of life and pain levels

Description

Time Frame

Up to 3 years

Title

Duration of response

Description

Time Frame

Up to 3 years

Title

Time to progression

Description

Assessed using the RECIST 1.1 criteria. Estimated using Kaplan-Meier curves.

Time Frame

Up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must have histologically-confirmed malignancy Patients must have recurrent or metastatic tumor located within a previously irradiated field Tumor within the irradiated field is negatively impacting patient's quality of life or threatening catastrophic complication if left untreated as determined by the treating physician Patient is not a candidate for, or has not demonstrated a significant local response to chemotherapy, biologic, hormonal ,or other therapies Patient is not a surgical candidate or tumor is not surgically resectable, as documented by surgical oncologist Information on previous radiation treatment, including total dose and fractionation must be available; additional information including radiation fields and dose-volume-histogram or isodose lines is preferable Tumor sites eligible for inclusion on this protocol include thorax, abdomen, and pelvis Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 in the previously irradiated field Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to radiation simulation, postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential) and nonlactating, and men and women must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy completed Eastern Cooperative Oncology Group (ECOG) performance status determined to be between 0 and 3 Absolute neutrophil count (ANC) >= 1,500/ul Platelets (PLT) >= 75,000/ul Subjects must sign a written informed consent and Health Insurance Portability and Accountability Act (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 chemotherapy or radiotherapy to the reirradiation target within 4 weeks prior to entering the study Concurrent chemotherapy or biologic therapy A history of ataxia telangiectasia or other documented history of radiation hypersensitivity Scleroderma or active connective tissue disease For abdominal or pelvic irradiation: active inflammatory bowel disease Serious, active infections requiring treatment with intravenous (IV) antibiotics Uncontrolled intercurrent illness including, but not limited to, or psychiatric illness/social situations that would limit compliance with study requirements Reirradiation targets located within the head, neck, or brain are excluded from this study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

C-M Charlie Ma, PhD

Organizational Affiliation

Fox Chase Cancer Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Josphua 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

19111-2497

Country

United States

12. IPD Sharing Statement

Learn more about this trial

3-Dimensional Conformal Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Recurrent Tumors

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