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Phase I Study of Pulsed Low Dose Rate Reirradiation Delivered With 3DCRT/IMRT

Phase 1
18 Years
Open (Enrolling)
Solid Tumor

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Trial Information

Phase I Study of Pulsed Low Dose Rate Reirradiation Delivered With 3DCRT/IMRT


I. To determine the maximum tolerated dose (MTD) of reirradiation with the pulsed low dose
rate technique.


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

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.

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD)

Outcome Description:

To determine the maximum tolerated dose (MTD) of reirradiation with the pulsed low dose rate technique. The MTD is defined as the dose level closest to, but not over that which is predicted to result in a DLT rate of 20%, the target toxicity rate. A dose limiting toxicity (DLT) is a grade ≥ 4 acute or grade ≥ 3 late toxicity of an organ system within the reirradiation field.

Outcome Time Frame:

During re-irradiation treatment through 30 days of completion of treatment

Safety Issue:


Principal Investigator

C-M Charlie Ma, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

November 2011

Completion Date:

November 2015

Related Keywords:

  • Solid Tumor
  • unspecified adult solid tumor
  • protocol specific



Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111