Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Adenocarcinoma

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Micronutrients

Anti-Infective Agents

All Drugs and Chemicals

Iodine

Cadexomer iodine

Patients received 45 Gy of external beam radiation therapy (EBRT)to the prostate followed (within 2 to 6 weeks) by permanent iodine (I-125) brachytherapy 108 Gy.

brachytherapy

iodine I 125

radiation therapy

W. Robert Lee, MD

RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Giving radiation therapy in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of external-beam radiation therapy followed by implanted radiation therapy in treating patients who have prostate cancer.

OBJECTIVES: I. Determine the acute and late grade 3-5 genitourinary (GU) and gastrointestinal (GI) toxic effects of external beam radiotherapy followed by permanent source brachytherapy using interstitial iodine I 125 seeds in patients with intermediate risk, clinically localized adenocarcinoma of the prostate. II. Determine the freedom from prostate specific antigen (PSA) failure, overall survival, disease specific survival, and local and/or distant clinical relapse rates in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients undergo external beam radiotherapy (EBRT) to the pelvis 5 days a week for 5 weeks. Permanent source brachytherapy comprised of ultrasound-guided implantation of iodine I 125 seeds into the prostate is performed 2-6 weeks after completion of EBRT. Patients are followed at 1, 3, 6, 9, and 12 months, then every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study within 1 year.

External-Beam Radiation Therapy Plus Implanted Radiation Therapy in Treating Patients With Prostate Cancer

A Phase II Study of External Beam Radiation Therapy Combined With Permanent Source Brachytherapy for Intermediate Risk Clinically Localized Adenocarcinoma of the Prostate

Rate of late severe GU and GI toxicity defined as grade 3-5 GU and GI toxicity based on Common Toxicity Criteria 2.0

Rate of acute severe GU and GI toxicity, defined as grde 3-5 GU and GI toxicity based on Common Toxicity Criteria 2.0

National Cancer Institute (NCI)

Radiation Therapy Oncology Group

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Recurrence

Glioblastoma

Glioma

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Astrocytoma

Oligodendroglioma

Gliosarcoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Brain Tumor, Adult

Anaplastic Astrocytoma

Anaplastic Oligodendroglioma

Neuroepithelioma

Dermatologic Agents

Coal Tar

adjuvant therapy

Larry Kleinberg, MD

RATIONALE: Brachytherapy uses radioactive material to kill cancer cells remaining after surgery.

PURPOSE: Phase I trial to study the effectiveness of brachytherapy in treating patients who have recurrent malignant glioma.

OBJECTIVES:

* Determine the maximum tolerated dose of brachytherapy using an intracavitary applicator and liquid iodine I 125 in patients with recurrent malignant glioma.
* Determine the acute and chronic toxicity of this therapy in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Within 3-21 days after surgical resection, patients receive brachytherapy using an intracavity balloon application (GliaSite) with iodine I 125 solution for a total of 5-7 days.

Cohorts of 5-10 patients receive escalating doses of brachytherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 10 patients experience dose-limiting toxicity.

Patients are followed at 4 weeks and then every 2 months for 1 year.

PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study.

Brachytherapy in Treating Patients With Recurrent Malignant Glioma

Phase I Brachytherapy Dose Escalating Study Using the Proxima Therapeutics, Inc. GliaSite RTS in Patients With Recurrent Malignant Gliomas

Antineoplastic Agents

Carmustine

Antineoplastic Agents, Alkylating

Alkylating Agents

polifeprosan 20 with carmustine implant

surgical procedure

Robert E. Albright, MD

RATIONALE: Internal radiation uses high-energy radiation to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining internal radiation therapy with chemotherapy implants may kill remaining tumor cells following surgery.

PURPOSE: Phase I trial to study the effectiveness of internal radiation therapy plus carmustine implants in treating patients who have recurrent or refractory malignant glioma.

OBJECTIVES: I. Assess the toxic effects of concurrent permanent iodine I 125 interstitial seed implants and polifeprosan 20 with carmustine implant (Gliadel wafers) in patients with recurrent or refractory malignant glioma. II. Assess preliminary efficacy of this regimen in terms of progression free survival and overall survival of these patients. III. Assess impact of this regimen on the quality of life and performance status of these patients. IV. Assess site of tumor progression following this regimen in these patients. V. Assess the relationship between progression free survival and the MIB-1 proliferative index of the resected malignant glioma.

OUTLINE: This is a dose escalation study. Patients undergo craniotomy with the intent to obtain a complete resection of enhancing tumor. Following maximum tumor removal, iodine I 125 seeds and up to 8 polifeprosan 20 with carmustine implants (Gliadel wafers) are implanted into the resected tumor cavity. Cohorts of 6 patients each receive increasing numbers of Gliadel wafers placed into the tumor cavity. Quality of life is assessed at baseline, then every 3 months, and at tumor progression. Patients are followed monthly until death.

PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study within 18 months.

Internal Radiation Therapy Plus Carmustine Implants in Treating Patients With Recurrent or Refractory Malignant Glioma

A Phase I Study of Concurrent Multi-modality Treatment for Patients With Relapsed Malignant Glioma Using Permanent I-125 Interstitial Seeds and Dose Escalation of Gliadel 3.85% Carmustine (BCNU) Polymer Wafers

Barrett Cancer Center

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Patients undergo sublobar resection comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.

Patients undergo 3 fractions of stereotactic body radiation therapy at 2-8 days apart.

therapeutic conventional surgery

stereotactic body radiation therapy

Hiran C. Fernando, MD

RATIONALE: Surgery with or without internal radiation therapy may be an effective treatment for non-small cell lung cancer. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known whether stereotactic body radiation therapy is more effective than surgery with or without internal radiation therapy in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying how well surgery with or without internal radiation therapy works compared with stereotactic body radiation therapy in treating patients with high-risk stage IA or stage IB non-small cell lung cancer.

OBJECTIVES:

Primary

* To ascertain whether patients treated by stereotactic body radiation therapy (SBRT) have a 3-year overall survival (OS) rate that is no more than 10% less than patients treated with sublobar resection (SR).

Secondary

* To compare loco-regional recurrence-free survival between study arms.
* To compare disease-free survival between study arms.
* To compare grade 3 or higher specific adverse event profiles between study arms at 1, 3, 6, and 12 months post-therapy.
* To compare pulmonary function between patients treated with SBRT and patients treated with SR.
* To compare the adverse events and pulmonary function tests (PFTs) in each arm for patients with low or high Charlson comorbidity index scores, including a test interaction between Charlson comorbidity index scores (low vs high) and treatment arm.

Tertiary

* To compare the quality-adjusted survival between the SBRT and SR treatments in terms of time to death (primary) and time until recurrence (secondary).
* To examine whether pre-operative and post-operative clinically significant deficits in previously identified prognostic PRO domains (overall quality of life \[QOL\], fatigue, anxiety, and dyspnea) are associated with shorter patient survival in this patient population and to compare the relative effectiveness of each treatment (SBRT and SR).
* To contribute to an ACOSOG bank of normative data in order to improve short/long-term outcomes of cancer patients by identifying patients experiencing clinically significant deficits in patient-reported outcomes and the relationship to genetic variables.
* To explore whether blood-based biomarkers, including osteopontins, will be able to predict which patients will be at high risk for recurrence by treatment with either SBRT or SR. (exploratory)
* To explore whether blood-based biomarkers, including TGF-β1, will be able to predict which patients will be at high risk for pulmonary complications by treatment with either SBRT or SR. (exploratory)

OUTLINE: This is a multicenter study. Patients are stratified according to planned brachytherapy (yes vs no) and ECOG performance status (0 vs 1 vs 2). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo sublobar resection comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy\* comprising an iodine I 125 implant at the resection margin.
* Arm II: Patients undergo 3 fractions of stereotactic body radiation therapy at 2-8 days apart.

NOTE: \*Patients may receive brachytherapy at the discretion of treating physician.

Patients may undergo blood sample collection at baseline and periodically during study for correlative studies. Tumor tissue samples may also be collected from patients who undergo resection.

Patients complete the Lung Cancer Symptom Scale (LCSS), the Linear Analogue Self-Assessment (LASA), and the UCDS Shortness of Breath quality-of-life questionnaires at baseline and periodically during study and follow-up.

After completion of study treatment, patients are followed up for 30 days, every 3 months for 2 years, every 6 months for 1 year, and then yearly for 2 years.

Surgery With or Without Internal Radiation Therapy Compared With Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Stage I Non-Small Cell Lung Cancer

A Randomized Phase III Study of Sublobar Resection (+/- Brachytherapy) Versus Stereotactic Body Radiation Therapy in High Risk Patients With Stage I Non-Small Cell Lung Cancer (NSCLC)

Overall survival is defined as the time from randomization until death from any cause.

Loco-regional recurrence is defined as recurrence within the same lobe or hilum (N1 nodes), or within 2 cm of the staple line or within 2 cm of the PTV after treatment effects such as scarring have subsided.

Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0.

Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.

Disease free survival is defined as the time from randomization until documented disease recurrence or death, whichever occurs first. Patient who are disease free and alive at the time of analysis will be censored at the time of their last follow up.

Pulmonary function test values include forced expiratory volume 1 (FEV1), carbon monoxide diffusion (DLCO) and forced vital capacity (FVC).

Alliance for Clinical Trials in Oncology

Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Please note that the death NOS reported fell outside of the reporting window and was queried on but since the trial was terminated midstream the data management was not completed.

Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.

Arm I (SR+Brachytherapy)

Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.

Arm II (SBRT)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Canada

United States

Region of Enrollment

Eastern Cooperative Oncology Group (ECOG) Performance Status

Institutional intent to use brachytherapy

Baseline diffusing capacity of the lung for carbon monoxide (DLCO)

Baseline Forced Expiratory Volume in 1 second (FEV1)

Study terminated prematurely. Planned analyses was not performed due to the nature of the closure endpoint data is not available.

3-year Overall Survival (OS) Rate

Loco-regional Recurrence-free Survival

Chest wall pain

Cough

Dyspnea

Hoarness

Hypoxia

Fatigue

All enrolled participants who received protocol interventions and had adverse events reported at 1 month post-therapy.

Adverse Event Profiles at 1 Month Post-therapy

All enrolled participants who received protocol interventions and had adverse event reported at months 3 post-therapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
External-Beam Radiation Therapy Plus Implanted Radiation Therapy in Treating Patients With Prostate Cancer	NCT00006365	Prostate Cancer	brachytherapy iodine I 125 radiation thera...	18 Years - 120 Years	Radiation Therapy Oncology Group
Brachytherapy in Treating Patients With Recurrent Malignant Glioma	NCT00045474	Brain and Centr...	adjuvant therap... iodine I 125	18 Years -	National Cancer Institute (NCI)
Internal Radiation Therapy Plus Carmustine Implants in Treating Patients With Recurrent or Refractory Malignant Glioma	NCT00003876	Brain and Centr...	polifeprosan 20... surgical proced... iodine I 125	18 Years -	National Cancer Institute (NCI)
Brachytherapy in Treating Patients With Recurrent Malignant Glioma	NCT00045474	Brain and Centr...	adjuvant therap... iodine I 125	18 Years -	National Cancer Institute (NCI)
Surgery With or Without Internal Radiation Therapy Compared With Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Stage I Non-Small Cell Lung Cancer	NCT01336894	Lung Cancer	therapeutic con... iodine I 125 stereotactic bo...	18 Years -	Alliance for Clinical Trials in Oncology

Spots Global Cancer Trial Database for iodine i 125

Every month we try and update this database with for iodine i 125 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.