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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Fox Chase Cancer Center
Sponsor:
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT01470365
First received: November 3, 2011
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: quality-of-life assessment
Radiation: intensity-modulated radiation therapy
Radiation: 3-dimensional conformal radiation therapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Pulsed Low Dose Rate Reirradiation Delivered With 3DCRT/IMRT for Palliation of Recurrent Tumors

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • MTD of reirradiation with the pulsed low dose rate technique [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Assessed using the RECIST 1.1 criteria. Estimated using Kaplan-Meier curves.


Estimated Enrollment: 24
Study Start Date: November 2011
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: quality of life assessment
Radiation: intensity-modulated radiation therapy
Undergo IMRT
Other Name: IMRT
Radiation: 3-dimensional conformal radiation therapy
Undergo 3-dimensional CRT
Other Names:
  • 3D conformal radiation therapy
  • 3D-CRT

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01470365

Locations
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: C-M Charlie Ma, PhD    215-214-1745    Charlie.Ma@fccc.edu   
Contact: Joshua Meyer, MD    215-728-2667    joshua.meyer@fccc.edu   
Principal Investigator: C-M Charlie Ma, PhD         
Principal Investigator: Joshua Meyer, MD         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT01470365     History of Changes
Other Study ID Numbers: OER-RT-042, NCI-2011-03311, IRB#11-044/OER-RT-042
Study First Received: November 3, 2011
Last Updated: May 2, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 28, 2014