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

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

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.

Study Overview

• Status: Completed
• Conditions: Unspecified Adult Solid Tumor, Protocol Specific
• Intervention / Treatment: Procedure: quality-of-life assessment; Radiation: intensity-modulated radiation therapy; Radiation: 3-dimensional conformal radiation therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111-2497
      • Fox Chase Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment (radiation therapy); 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.	Procedure: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Radiation: intensity-modulated radiation therapy; Undergo IMRT; Other Names: IMRT; Radiation: 3-dimensional conformal radiation therapy; Undergo 3-dimensional CRT; Other Names: 3D-CRT; 3D conformal radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 3 years
Time to progression	Assessed using the RECIST 1.1 criteria. Estimated using Kaplan-Meier curves.	Up to 3 years
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.	Up to 3 years

Collaborators and Investigators

• Sponsor: Fox Chase Cancer Center
• Investigators: Principal Investigator: C-M Charlie Ma, PhD, Fox Chase Cancer Center; Principal Investigator: Josphua Meyer, MD, Fox Chase Cancer Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 3, 2011
• Primary Completion (ACTUAL): August 31, 2015
• Study Completion (ACTUAL): February 21, 2019

Study Registration Dates

• First Submitted: November 3, 2011
• First Submitted That Met QC Criteria: November 9, 2011
• First Posted (ESTIMATE): November 11, 2011

Study Record Updates

• Last Update Posted (ACTUAL): May 8, 2020
• Last Update Submitted That Met QC Criteria: May 6, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: OER-RT-042; NCI-2011-03311 (REGISTRY: CTRP (Clinical Trial Reporting Program)); IRB#11-044/OER-RT-042 (OTHER: Fox Chase Cancer Center)