Status:
COMPLETED
3-Dimensional Conformal Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Recurrent Tumors
Lead Sponsor:
Fox Chase Cancer Center
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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....
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 no...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 3 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01470365
Start Date
November 3 2011
End Date
February 21 2019
Last Update
May 8 2020
Active Locations (1)
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1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497