Overview

This trial is active, not recruiting.

Condition unspecified adult solid tumor, protocol specific
Treatments quality-of-life assessment, intensity-modulated radiation therapy, 3-dimensional conformal radiation therapy
Phase phase 1
Sponsor Fox Chase Cancer Center
Start date November 2011
End date August 2015
Trial size 24 participants
Trial identifier NCT01470365, IRB#11-044/OER-RT-042, NCI-2011-03311, OER-RT-042

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
quality-of-life assessment quality of life assessment
Ancillary studies
intensity-modulated radiation therapy IMRT
Undergo IMRT
3-dimensional conformal radiation therapy 3D conformal radiation therapy
Undergo 3-dimensional CRT

Primary Outcomes

Measure
MTD of reirradiation with the pulsed low dose rate technique
time frame: Up to 30 days

Secondary Outcomes

Measure
Palliative efficacy in terms of quality of life and pain levels
time frame: Up to 3 years
Duration of response
time frame: Up to 3 years
Time to progression
time frame: Up to 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase I Study of Pulsed Low Dose Rate Reirradiation Delivered With 3DCRT/IMRT for Palliation of Recurrent Tumors
Principal investigator C-M Charlie Ma, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Fox Chase Cancer Center.
Location data was received from the National Cancer Institute and was last updated in April 2016.