Clinical trial · Interventional
3-Dimensional Conformal Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Recurrent Tumors
Phase I Study of Pulsed Low Dose Rate Reirradiation Delivered With 3DCRT/IMRT for Palliation of Recurrent Tumors
NCT01470365CI-TRIAL-00045006completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-dimensional conformal radiation therapy | Radiation | — | UNRESOLVED |
| intensity-modulated radiation therapy | Radiation | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (radiation therapy)
- description
- 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.
- interventionNames
- Procedure: quality-of-life assessment
- Radiation: intensity-modulated radiation therapy
- Radiation: 3-dimensional conformal radiation therapy
Primary outcomes (1)
- measure
- MTD of reirradiation with the pulsed low dose rate technique
- timeFrame
- Up to 30 days
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.