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CompletedNCT01470365Updated May 8, 2020

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

A Phase 1 interventional study of quality-of-life assessment and intensity-modulated radiation therapy in Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Fox Chase Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-08.

Sponsored by Fox Chase Cancer Center · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Unspecified Adult Solid Tumor, Protocol Specific

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03

In context

Recurrence

4,278 studies on the registry are indexed under Recurrence; 990 are open to participants now.

This study's enrollment of 24 is below the median of 50 across 3,373 interventional studies indexed under Recurrence.

Browse Recurrence studies →

Lead sponsor

Fox Chase Cancer Center is the lead sponsor of 211 studies on the registry; 30 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 8 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • 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 · Radiation: intensity-modulated radiation therapy · Radiation: 3-dimensional conformal radiation therapy

Interventions

  • Procedurequality-of-life assessment

    Ancillary studies

    Also known as: quality of life assessment

  • Radiationintensity-modulated radiation therapy

    Undergo IMRT

    Also known as: IMRT

  • Radiation3-dimensional conformal radiation therapy

    Undergo 3-dimensional CRT

    Also known as: 3D conformal radiation therapy, 3D-CRT

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 30 days

Secondary outcomes

  1. 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.

    Time frame: Up to 3 years

  2. 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 frame: Up to 3 years

  3. Time to progression

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

    Time frame: Up to 3 years

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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01470365
Lead sponsor
Fox Chase Cancer Center
Responsible party
Sponsor
First posted
Nov 11, 2011
Start date
Nov 3, 2011
Primary completion
Aug 31, 2015
Completion
Feb 21, 2019
Last update
May 8, 2020

Study contacts

C-M Charlie Ma, PhD
principal investigator · Fox Chase Cancer Center
Josphua Meyer, MD
principal investigator · Fox Chase Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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