Recurrent Disease Clinical Trial
Official title:
Definitive Re-irradiation With Proton Beam Radiotherapy for Patients With Recurrent Thoracic Cancers
Verified date | November 2018 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This pilot clinical trial studies proton beam radiation therapy in treating patients with thoracic cancer that has come back and have received prior radiation therapy. Proton beam radiation therapy uses high energy protons to kill tumor cells and may cause less damage to normal tissue.
Status | Completed |
Enrollment | 6 |
Est. completion date | September 7, 2017 |
Est. primary completion date | September 7, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
Inclusion Criteria: - Women of child-bearing age must have a negative pregnancy test - Patients must have received prior radiation treatment to the chest; records of prior radiation treatment must be available - Patients must have received prior chest radiation at least 3 months prior to enrollment in this trial; radiation treatment to other body sites not overlapping with current radiation fields are allowed within the 3 months period (example, brain radiation is allowed) - Patients must have a prior diagnosis of cancer inside the thoracic cavity; both primary thoracic malignancies (such as lung cancer) as well as metastatic lesions (such as metastatic breast cancer or colorectal cancer to the lungs) are allowed; patient must have pathologic confirmation of the recurrent thoracic tumor, or have an enlarging thoracic mass (as seen on two computed tomography [CT] scans at least 6 weeks apart, with either a > 25% or > 5 mm increase in longest dimension) - Patients must have a life expectancy of > 6 months - Patients must have measurable disease to be treated with proton radiation (minimum tumor dimension at least 10 mm on CT imaging) - Patients should have either non-metastatic cancer of the thorax, or metastatic cancer to the thorax and candidate for definitive radiation dose to the thoracic tumor (not palliative intent), tumor radiation dose to at least BED2Gy 60 Gy - Patients must be able to receive proton radiation treatment - All stages of cancer are eligible - There are no limits on prior therapy; patients are allowed to have prior chemotherapy and surgery; patients are allowed to have concurrent chemotherapy with radiation treatment; patients are allowed to have chemotherapy or surgery after radiation treatment - Patients are allowed to be on another study concurrent with this protocol - Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: - Patients who have never received radiation to the chest - Patients who received radiation to the chest within the past 3 months (in a region that overlaps with current radiation fields) - Patients with life expectancy < 6 months - Pregnant women - Patients unable to provide informed consent - Prisoners |
Country | Name | City | State |
---|---|---|---|
United States | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington |
United States | ProCure Proton Therapy Center-Seattle | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Grade 3 or Greater Toxicity Attributable to Radiation Treatment | Toxicity will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 3 generally means hospitalization required for management of side effects. | Up to 3 months post-treatment | |
Secondary | Number of Participants With Grade 2 Toxicity Attributable to Radiation Treatment | Toxicity will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) v 4.0. Grade 2 generally means medical therapy required to intervene due to toxicity. | Up to 3 months post-treatment | |
Secondary | Number of Participants With Local Control of Cancer | Number of participants who did not have local failure as defined by: tumor progression per Response Evaluation Criteria in Solid Tumors criteria - at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions inside the full dose radiation field. | Up to 3 months post-treatment | |
Secondary | Number of Participants Alive | Number of participants alive. | Up to 3 months post-treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01445080 -
Sorafenib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia
|
Phase 1/Phase 2 | |
Terminated |
NCT03525392 -
Study to Evaluate the Safety and Activity (Including Distribution) of 177Lu-3BP-227 in Subjects With Solid Tumours Expressing Neurotensin Receptor Type 1.
|
Phase 1 | |
Completed |
NCT01794845 -
Phase II Trial Using Erbitux+ Taxotere With Low Dose Fractionated Radiation for Recurrent Unresectable Locally Advanced Head and Neck Carcinoma
|
Phase 2 | |
Completed |
NCT02210858 -
Tipifarnib in Treating Patients With Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or Undifferentiated Myeloproliferative Disorders
|
Phase 1/Phase 2 | |
Recruiting |
NCT05432518 -
Pilot Trial for Treatment of Recurrent Glioblastoma
|
Early Phase 1 | |
Completed |
NCT00351975 -
Belinostat and Azacitidine in Treating Patients With Advanced Hematologic Cancers or Other Diseases
|
Phase 1 | |
Completed |
NCT03060096 -
Stepped-Care Telehealth for Distress in Cancer Survivors
|
N/A | |
Not yet recruiting |
NCT03591666 -
A Study of Anlotinib in Recurrent/Metastatic Head and Neck Adenocarcinomas
|
Phase 2 | |
Completed |
NCT00036738 -
Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, Dasatinib, or Nilotinib
|
Phase 2 | |
Recruiting |
NCT05260671 -
Penpulimab in Combination With Cetuximab as First-line Treatment in R/M SCCHN
|
Phase 2 | |
Completed |
NCT01737450 -
Activity and Safety Study of BKM120 in Monotherapy in Patient With Metastatic Head and Neck Cancer Recurrent or Progressive
|
Phase 2 | |
Completed |
NCT03415477 -
Denosumab: A Potential Treatment Option for Aneurysmal Bone Cysts
|
Phase 1/Phase 2 | |
Recruiting |
NCT06088719 -
Safety of Omitting Axillary Surgery in Breast Cancer Patients With Isolated Chest Wall Recurrence
|
||
Terminated |
NCT00408252 -
Efficacy of SU 011248 in Head And Neck Carcinoma
|
Phase 2 | |
Terminated |
NCT02488512 -
Peptide Receptor Radionuclide Therapy With 90Y-Dotatoc in Relapsed/Refractory Diffuse Large B Cell and Mantle Cell Lymphomas
|
Phase 2 | |
Recruiting |
NCT02747732 -
Study of Ibrutinib in Combination With Bendamustine and Rituximab for Patients With Relapsed/Refractory Aggressive BCL
|
Phase 2 | |
Completed |
NCT00383474 -
Tipifarnib and Bortezomib in Treating Patients With Acute Leukemia or Chronic Myelogenous Leukemia in Blast Phase
|
Phase 1 | |
Completed |
NCT00003145 -
Fludarabine Phosphate, Low-Dose Total-Body Irradiation, and Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Older Patients With Chronic Myeloid Leukemia
|
Phase 2 | |
Recruiting |
NCT06014619 -
Complications and Recurrences After Mohs Micrographic Surgery and Slow Mohs
|
||
Active, not recruiting |
NCT03792256 -
Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)
|
Phase 1 |