Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-10 @ 9:51 AM
Study NCT ID:
NCT02046304
Status:
COMPLETED
Last Update Posted:
2016-04-06
First Post:
2014-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PP-Gemcitabine & External Beam Radiation-Sarcomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-04', 'studyFirstSubmitDate': '2014-01-23', 'studyFirstSubmitQcDate': '2014-01-23', 'lastUpdatePostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose of Preoperative Gemcitabine with External-Beam Radiation Therapy', 'timeFrame': '6 weeks', 'description': 'The maximum tolerated dose (MTD) defined as the dose having posterior expected toxicity importance score (TIS) closest to the target 1.65 at the end of the trial.'}], 'secondaryOutcomes': [{'measure': 'Response to Preoperative Gemcitabine with External-Beam Radiation Therapy', 'timeFrame': '3 months after completion of all treatment', 'description': 'Response to preoperative chemoradiotherapy measured by comparing pre- and post-treatment MRI scans using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Evaluation of the MRI-defined change used to measure radiographic response.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sarcoma', 'Soft Tissue Sarcomas', 'STS', 'Extremity and Trunk', 'Gemcitabine', 'Gemcitabine Hydrochloride', 'Gemzar', 'External beam radiation therapy', 'EBRT', 'Radiotherapy', 'XRT'], 'conditions': ['Sarcoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical research study is to find the highest safe dose of gemcitabine that can be given with radiotherapy before surgery to treat sarcoma. This study will also look at how well this treatment controls sarcoma.', 'detailedDescription': 'Before the start of treatment, participants will have a physical exam, blood tests, a MRI scan, and a chest x-ray. A PET scan may be done if thought necessary.\n\nParticipants will receive the drug gemcitabine by vein along with radiation therapy on Days 1, 8, 22, 29, 43, and 50. Radiation treatments will be given 5 days a week for 5 weeks. The gemcitabine and radiotherapy will be given on an outpatient basis. Chemotherapy and/or radiotherapy may be stopped if side effects become severe.\n\nAbout 4 to 6 weeks after the final dose of gemcitabine, surgery will be done to remove the tumor or to remove any previous surgical scar and leftover tumor.\n\nDuring the combined treatment, participants will be seen weekly by the doctor in charge of radiotherapy or by the study nurse. Blood tests will be done every week during treatment. A MRI scan and a chest x-ray will be done within 14 days before surgery. A PET scan will be done if thought necessary.\n\nAfter the surgery is done, participants will return to M. D. Anderson for follow-up visits every 4 months for the first 2 years, every 6 months for 3 years, and then yearly from then on. An ultrasound and MRI scan (of the extremity or trunk) will be done 3 months after completion of all treatment. Ultrasound scans will be performed at each visit. A MRI scan will only be done again at later visits if needed.\n\nThis is an investigational study. Gemcitabine is approved for use by the FDA. Its use together with radiation therapy in this study is experimental. About 36 individuals will take part in the study. All will be enrolled at M. D. Anderson.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with cytologic or histologic proof of Grade II or III resectable soft tissue sarcoma of the extremity or trunk.\n2. Patients with both measurable and non-measurable disease. Patients who are S/P pre-referral excision will be eligible.\n3. Inclusion of patients with a prior history of malignancy will be at the discretion of the Study Chairman.\n4. Patients must have a Zubrod Point Scale of 0 or 1.\n5. Absolute neutrophil count must be \\> 1,500 cells/mm; platelet count greater than or equal to 100,000 platelets/ml; serum creatinine less than or equal to 1.8 mg/dl, serum glutamate oxaloacetate transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) less than or equal to 3 x normal, total bilirubin less then or equal to 1.5 mg/dl.\n6. Patients must have no uncontrolled coexisting medical conditions.\n7. Women of childbearing potential must not be pregnant or breast feeding and must practice adequate contraception.\n8. All patients must sign an informed consent.\n\nExclusion Criteria:\n\n1\\) Patients with a history of prior radiotherapy in the area of the primary tumor or those in whom the anticipated radiation field would include the perineum, scrotum, or vaginal introitus will not be eligible.'}, 'identificationModule': {'nctId': 'NCT02046304', 'briefTitle': 'PP-Gemcitabine & External Beam Radiation-Sarcomas', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'A Phase I Study of Preoperative Concomitant Gemcitabine and External-Beam Radiation Therapy and Surgical Resection for Patients With Extremity and Trunk Soft Tissue Sarcomas', 'orgStudyIdInfo': {'id': 'ID01-532'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gemcitabine + Radiation Therapy', 'description': 'Patients receive concurrent chemoradiation (days 1 - 33) consisting of external beam radiotherapy (EBRT) plus gemcitabine, administered in a phase I dose escalation format until MTD is reached. EBRT delivered preoperatively (for patients with measurable disease) or postoperatively (for patients who have undergone pre-referral excisional biopsy) to a dose of 50 Gy in 25 fractions at 2.0 Gy per fraction. Radiotherapy given once daily (Monday through Friday) for 5 weeks. Surgical resection of the post-treatment tumor mass performed 4 to 8 weeks after the final dose of gemcitabine. Gemcitabine administered intravenously (IV) on days 1, 8, 22, 29, 43, and 50, concurrently with radiotherapy. Starting dose of gemcitabine 400 mg/m2 by vein once a week.', 'interventionNames': ['Drug: Gemcitabine', 'Radiation: Radiation Therapy']}], 'interventions': [{'name': 'Gemcitabine', 'type': 'DRUG', 'otherNames': ['Gemcitabine Hydrochloride', 'Gemzar'], 'description': 'Starting dose: 400 mg/m2 by vein on days 1, 8, 22, 29, 43, and 50.', 'armGroupLabels': ['Gemcitabine + Radiation Therapy']}, {'name': 'Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['XRT', 'EBRT', 'Radiotherapy'], 'description': 'Radiation therapy dose of 50 Gy in 25 fractions at 2.0 Gy per fraction. Radiotherapy given once daily (Monday through Friday) for 5 weeks.', 'armGroupLabels': ['Gemcitabine + Radiation Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Peter W. Pisters, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}