Non-Small Cell Lung Carcinoma Clinical Trial
Official title:
Phase II, Randomized, Double-Blind, Multicenter Trial of Subcutaneous Amifostine (Ethyol®) Versus Placebo in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients With Unresectable Non-Small Cell Lung Cancer
Verified date | August 2007 |
Source | MedImmune LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The primary objective of this study is to assess the activity of subcutaneous (SC) amifostine on the incidence and severity of acute radiochemotherapy-induced esophagitis in patients with unresectable Stage IIIA or IIIB non-small cell lung cancer (NSCLC) receiving combined modality therapy.
Status | Completed |
Enrollment | 130 |
Est. completion date | August 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
You may be eligible for this study if you are 18 years of age or older and: - Have UnResectable Stage IIIA or IIIB Non Small Cell Lung Cancer - Have never had prior chemotherapy with Paclitaxel or Carboplatin - Have never had prior thoracic radiation therapy (XRT) |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | St. Agnes Health Care | Baltimore | Maryland |
United States | Center for Cancer & Blood Disorders | Bethesda | Maryland |
United States | Cooper University Hospital | Camden | New Jersey |
United States | Charleston Cancer Center | Charleston | South Carolina |
United States | The Center for Radiation Oncology | Danville | Virginia |
United States | Providence Everett Medical Center | Everett | Washington |
United States | Chesapeake Oncology-Hematology Associates | Glen Burnie | Maryland |
United States | Florida Wellcare Alliance | Inverness | Florida |
United States | University of Kentucky | Lexington | Kentucky |
United States | Cedars Sanai | Los Angeles | California |
United States | Cancer Center of Upper Delaware Valley | Milford | Pennsylvania |
United States | Long Island Jewish Medical Center | New Hyde Park | New York |
United States | Florida Community Cancer Center | New Port Richey | Florida |
United States | Beth Israel Hospital | New York | New York |
United States | Montgomery Cancer Center | Norristown | Pennsylvania |
United States | Ormand Memorial Cancer Center | Ormand Beach | Florida |
United States | Valley Medical Center | Renton | Washington |
United States | Upstate NY Cancer R&E Foundation | Rochester | New York |
United States | Radiation Oncology Center | Sacramento | California |
United States | Sarasota Memorial Hospital | Sarasota | Florida |
United States | St. John's Medical Research | Springfield | Missouri |
United States | University Community Hospital-Center for Cancer Care | Tampa | Florida |
United States | The Center for Cancer Care | Torrington | Connecticut |
United States | New Hanover Radiation | Wilmington | North Carolina |
Lead Sponsor | Collaborator |
---|---|
MedImmune LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | - Acute radiochemotherapy-induced esophagitis will be assessed from the time of randomization through up to 3 months after completion of radiochemotherapy treatment. | |||
Secondary | - Acute radiochemotherapy-induced pneumonitis will be assessed until 6 months after the last dose of XRT. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05110196 -
Study of Capmatinib in Indian Patients With MET Exon 14 Skipping Mutation Positive Advanced NSCLC.
|
Phase 4 | |
Completed |
NCT02795156 -
Study Assessing Activity of Molecularly Matched Targeted Therapies in Select Tumor Types Based on Genomic Alterations
|
Phase 2 | |
Terminated |
NCT02556593 -
IMRT Combined With Erlotinib for EGFR Wild Type Non-small Cell Lung Cancer With 4-10 Brain Metastases
|
Phase 2 | |
Active, not recruiting |
NCT03678350 -
Light Dosimetry for Photodynamic Therapy With Porfimer Sodium in Treating Participants With Malignant Mesothelioma or Non-Small Cell Lung Cancer With Pleural Disease Undergoing Surgery
|
Phase 1 | |
Recruiting |
NCT05358249 -
Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
|
Phase 1/Phase 2 | |
Recruiting |
NCT02273271 -
Evaluation of FLT-PET and DWI-MRI in Patients With NSCLC Treated With a Platinum-based Doublet as Preoperative Chemo
|
N/A | |
Withdrawn |
NCT03408561 -
Social Media Listening in Improving Clinical Trial Recruitment in Patients With Cancer
|
N/A | |
Active, not recruiting |
NCT04984811 -
NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC
|
Phase 2 | |
Completed |
NCT02922777 -
Trial of Dose Escalated BGB324 in Previously Treated Non-small Cell Lung Cancer.
|
Phase 1 | |
Active, not recruiting |
NCT01279408 -
Observing Patients With Palliative Asymptomatic Centrally Located Advanced Non-small Cell Lung Carcinoma (NSCLC)
|
||
Active, not recruiting |
NCT03731585 -
Online Psychosocial Intervention in Improving Social Well-Being and Support in Women With Stage I-IV Non-small Cell Lung Cancer Undergoing Treatment
|
N/A | |
Active, not recruiting |
NCT02009449 -
A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT00540514 -
Albumin-bound Paclitaxel (ABI-007) for Patients With Advanced Non-Small Cell Lung Cancer
|
Phase 3 | |
Completed |
NCT03849469 -
A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT02848872 -
Evaluation of Tumor and Blood Immune Biomarkers in Resected Non-small Cell Lung Cancer
|
||
Not yet recruiting |
NCT06222489 -
Whole Body HER3 Quantification With Radiolabelled Patritumab Deruxtecan (HER3-DXd) PET/CT
|
Phase 2 | |
Active, not recruiting |
NCT03752398 -
A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)
|
Phase 1 | |
Terminated |
NCT01288430 -
A Study of DS-2248 in Participants With Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05642195 -
Evaluation of a Cancer Lysate Vaccine and Montanide (Registered Trademark) ISA-51 VG With or Without the IL-15 Super-Agonist N-803 as Adjuvant Therapy for PD-L1 Negative Non-Small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT02394548 -
Phase I Trial Of IMRT Using A Contralateral Esophagus Sparing Technique (CEST) In Locally Advanced Lung Cancer
|
N/A |