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

NCT01470365 | Completed Phase 1 DMC

• 3 other identifiers: OER-RT-042NCI-2011-03311IRB#11-044/OER-RT-042
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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. Radiation therapy (RT) uses high energy x rays to kill tumor cells. Palliative radiation therapy may help patients with recurrent tumors live more comfortably.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

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.

  Up to 30 days

Secondary Outcomes (3)

• Palliative efficacy in terms of quality of life and pain levels

  Up to 3 years

• Duration of response

  Up to 3 years

• Time to progression

  Up to 3 years

Study Arms (1)

Treatment (radiation therapy)

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.

Procedure: quality-of-life assessment; Radiation: intensity-modulated radiation therapy; Radiation: 3-dimensional conformal radiation therapy

Interventions

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Treatment (radiation therapy)

intensity-modulated radiation therapy RADIATION

Undergo IMRT

Also known as: IMRT

Treatment (radiation therapy)

3-dimensional conformal radiation therapy RADIATION

Undergo 3-dimensional CRT

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

Treatment (radiation therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

MeSH Terms

Interventions

Radiotherapy, Intensity-Modulated; Radiotherapy, Conformal

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• C-M Charlie Ma, PhD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

• Josphua Meyer, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2011
• First Posted: November 11, 2011
• Study Start: November 3, 2011
• Primary Completion: August 31, 2015
• Study Completion: February 21, 2019
• Last Updated: May 8, 2020

Record last verified: 2020-05

Locations

US (1)