Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2026-02-12 @ 7:04 PM
Study NCT ID:
NCT05419518
Status:
UNKNOWN
Last Update Posted:
2023-11-14
First Post:
2022-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D001859', 'term': 'Bone Neoplasms'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is an, open label, single-institution, Phase II trial of palliative radiation dose escalation study for painful non-spine bone Metastases and painful non-bone metastases.\n\nDose escalation with 2D/ 3D-CRT in ten fractions in non-spine bone metastases will be evaluated. The total dose will range from 40-50 Gy depending on normal tissue constraints. This dose in ten fractions will lead to BED10 of 56 - 75 Gy which is higher than the BED10 39 Gy with 30 Gy in ten fractions.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-12', 'studyFirstSubmitDate': '2022-06-10', 'studyFirstSubmitQcDate': '2022-06-10', 'lastUpdatePostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain as assessed by number of participants experiencing pain response', 'timeFrame': 'One month', 'description': 'will be measured according to the international consensus guidelines on palliative RT13.\n\nPain assessment will be based on scores in Numerical Rating Pain Scale (NRPS), Visual analog scale (VAS) and Opioid analgesic use (an oral morphine equivalent dose (OMED)) in mg.\n\nComplete response is defined as a pain score of 0 on a scale from 0 to 10 and without an increase in OMED medication use.\n\nPartial response is defined as a decline of ≥2 points in pain score without analgesic increase or a decline in use of OMED of at least 25% or more from baseline without an increase in pain.\n\nPain progression (PP) is an increase of ≥2 points without a change in OMED use or an increase of 25% or more in OMED compared with baseline with the pain score stable or one point above baseline.'}, {'measure': 'Quality-of-life (QOL) as assessed by the Brief Pain Inventory (BPI). Using the 16 item scale', 'timeFrame': 'One month', 'description': 'Quality-of-life (QOL) instruments specific to participants with bone metastases or to those receiving palliative care have been developed in recent years. The Brief Pain Inventory (BPI) have shown excellent reliability and validity in assessing participants with bone metastases fourteen. BPI will be used for QOL assessment at baseline and one month after treatment.The BPI scale defines pain as follows:\n\nWorst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.'}], 'primaryOutcomes': [{'measure': 'Safety as assessed by number of participants experiencing adverse events', 'timeFrame': 'One month', 'description': 'Number of participants experiencing adverse effects grade three or higher, as defined by Common Terminology Criteria for Adverse Effects version 5.0 (CTCAE v5.0)'}], 'secondaryOutcomes': [{'measure': 'Severity as assessed by number of participants experiencing toxicity and adverse events', 'timeFrame': 'One month', 'description': 'This study will utilize the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 5.0 for toxicity and Adverse Event reporting'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metastase', 'Bone Neoplasms', 'Dose Fractionation, Radiation'], 'conditions': ['Neoplasm Metastases', 'Metastases, Neoplasm']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that with dose escalation to 40-50 Gy in ten fractions, the complete pain response rate at one month can be increased to 40-50% in painful non-spinal bone metastases. Additionally, the investigators hypothesize that utilizing a fractionation scheme with an escalated biologically equivalent dose (BED) will result in a higher proportion of participants responding to treatment, and will also lead to more durable responses. Furthermore, the investigators hypothesize that with dose escalation to 40-50 Gy in ten fractions, the complete pain response rate at one month can be increased to 35-45% in painful non-bone metastases', 'detailedDescription': 'The purpose of this study is to prospectively evaluate dose escalation and pain response in patients with painful non-spinal bone metastases and painful non-bone metastases treated with radiation therapy.\n\nPrimary Objective:\n\nTo evaluate improvement of complete pain response rate in painful non-spine bone metastases and painful non-bone metastases with dose escalated radiation using a ten fraction radiation regimen\n\nSecondary Objectives:\n\nTo evaluate best pain response To evaluate mean pain scores To evaluate the duration of pain response To evaluate the changes in quality-of-life following radiation To evaluate the rates of retreatment with radiation secondary to disease or symptom progression To evaluate treatment related toxicity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have provided signed informed consent for the trial\n* Aged ≥18 years at the time of informed consent\n* Histologic proof of malignancy\n* Radiologic or histologic evidence of bone metastases or non-bone metastases\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≥3\n* Pain Score ≥ 3\n* Life expectancy of six months or more\n* Willing and able to comply with all aspects of the protocol\n* A female participant is eligible to participate if she is not pregnant and not breastfeeding\n* Woman of childbearing potential who agrees to follow contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.\n* A male participant must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Metastasis from a highly radiosensitive tumor (eg, lymphoma, myeloma, germ cell tumor)\n* Spinal metastasis\n* Active compression of spinal cord/cauda equina\n* Previous RT or SBRT to the same site\n* \\> 3 sites requiring radiation treatment'}, 'identificationModule': {'nctId': 'NCT05419518', 'briefTitle': 'Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metas', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metastases', 'orgStudyIdInfo': {'id': '152201'}, 'secondaryIdInfos': [{'id': 'Pro2022000822', 'type': 'OTHER', 'domain': 'Rutgers, The State University of New Jersey'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Palliative radiation dose escalation', 'description': 'The prescribed dose is 50 Gy in 10 fractions. The total dose can be reduced to 40 Gy and the total number of fractions can be reduced to 8 fractions in non-spine metastases to achieve the normal tissue constraints.', 'interventionNames': ['Biological: EXTERNAL BEAM RADIATION']}, {'type': 'NO_INTERVENTION', 'label': 'Therapeutic benefit', 'description': 'Radiation will be delivered as per protocol. For participants experiencing unacceptable toxicity related to study treatment, yet obtaining therapeutic benefit, participants will be allowed to continue treatment, if well tolerated at the discretion of the investigator.'}], 'interventions': [{'name': 'EXTERNAL BEAM RADIATION', 'type': 'BIOLOGICAL', 'description': 'A minimum of three daily radiation therapy treatments are required in any given week. Any missed radiation treatments will be made up at the end of the treatment schedule, such that the total number of delivered 5 Gy fractions remains ten.', 'armGroupLabels': ['Palliative radiation dose escalation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08690', 'city': 'Hamilton', 'state': 'New Jersey', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew P Deek, MD', 'role': 'CONTACT', 'email': 'Deekmp@cinj.Rutgers.edu', 'phone': '732-253-3941'}], 'facility': 'RWJBarnabas Health - Robert Wood Johnson University Hospital', 'geoPoint': {'lat': 40.20706, 'lon': -74.08125}}, {'zip': '08701', 'city': 'Lakewood', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'RWJBarnabas Health - Monmouth Medical Center Southern Campus', 'geoPoint': {'lat': 40.09789, 'lon': -74.21764}}, {'zip': '10457', 'city': 'Livingston', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew P Deek, MD', 'role': 'CONTACT', 'email': 'Deekmp@cinj.Rutgers.edu', 'phone': '732-253-3941'}], 'facility': 'RWJBarnabas Health - Saint Barnabas Medical Center', 'geoPoint': {'lat': 40.79593, 'lon': -74.31487}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Robert Wood Johnson University Hospital', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '08876', 'city': 'Somerset', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew P Deek, MD', 'role': 'CONTACT', 'email': 'Deekmp@cinj.Rutgers.edu', 'phone': '732-253-3941'}], 'facility': 'RWJBarnabas Health - Robert Wood Johnson University Hospital', 'geoPoint': {'lat': 40.4976, 'lon': -74.48849}}, {'zip': '08755', 'city': 'Toms River', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'RWJBarnabas Health - Community Medical Center', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}], 'centralContacts': [{'name': 'Matthew P Deek, MD', 'role': 'CONTACT', 'email': 'Deekmp@cinj.Rutgers.edu', 'phone': '732-253-3941'}, {'name': 'Salma Jabbour, MD', 'role': 'CONTACT', 'email': 'jabbousk@cinj.rutgers.edu', 'phone': '732-253-3961'}], 'overallOfficials': [{'name': 'Matthew P Deek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers Cancer Institute of New Jersey'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Radiation Oncology', 'investigatorFullName': 'Matthew Pierre Deek', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}}