Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-25 @ 3:58 PM
Study NCT ID:
NCT00231868
Status:
COMPLETED
Last Update Posted:
2020-08-12
First Post:
2005-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Radiation Therapy and Paclitaxel and Carboplatin in Patients With Uterine Papillary Serous Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'DYKUO@montefiore.org', 'phone': '718-405-8082', 'title': 'Dr. Dennis Yi-Shin Kuo', 'organization': 'Montefiore Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'There are minor differences in the carboplatin doses between the current trial and our pilot study.\n\nThis is a single institution trial. A limited number of advanced stage patients was accrued.'}}, 'adverseEventsModule': {'timeFrame': '435 cycles of paclitaxel/carboplatin were administered on protocol from which frequencies and grades of hematologic and non-hematologic toxicities were tabulated for up to 10 years.', 'description': 'There is no difference in the reporting of adverse events. Adverse even data is not available. Only the toxicity data are available.', 'eventGroups': [{'id': 'EG000', 'title': 'Carboplatin & Paclitaxel & Radiation: Pelvic Radiation Therapy', 'description': 'Drug:Carboplatin and Paclitaxel and Radiation: Pelvic Radiation Therapy\n\nCarboplatin and Paclitaxel and Pelvic Radiation Therapy : Paclitaxel 175 mg/m2/3 hour \\& Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour \\& Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles\n\nNote: The original PI has left the institution, therefore Dr. Kuo inherited the study. Efforts were made to contact the PI/study team members to locate the raw data, but were unsuccessful. No AE data are available at this time.', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 0, 'seriousNumAtRisk': 72, 'deathsNumAffected': 16, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'To Evaluate the Toxicity and Tolerability of Pelvic Radiation "Sandwiched" Between Cycles of Paclitaxel/Carboplatin Chemotherapy in Patients With UPSC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug:Carboplatin, Paclitaxel & Radiation', 'description': 'Drug:Carboplatin and Paclitaxel and Radiation: Pelvic Radiation Therapy\n\nCarboplatin and Paclitaxel and Pelvic Radiation Therapy: Paclitaxel 175 mg/m2/3 hour \\& Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour \\& Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles\n\nCarboplatin and Paclitaxel and Radiation Therapy: Paclitaxel 175 mg/m2/3 hour \\& Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour \\& Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles'}], 'classes': [{'title': 'Early stage (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '65.5', 'spread': '3.6', 'groupId': 'OG000'}]}]}, {'title': 'Late stage (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.8', 'spread': '3.0', 'groupId': 'OG000'}]}]}, {'title': 'Early stage (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '76.5', 'spread': '4.3', 'groupId': 'OG000'}]}]}, {'title': 'Late stage (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.9', 'spread': '5.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 7 years', 'description': 'Overall survival analysis of early stage (stage 1 \\& 2) and late stage (stage 3 \\& 4)UPSC patients who were prescribed radiation "sanwhiched" between three cycles of paclitaxel/platinum chemotherapy before and after RT. Outcome measures were Progression Free Survival (PFS) and Overall Survival (OS).', 'unitOfMeasure': 'months', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Kaplan-Meier survival analysis of Progression Free Survival (PFS) and Overall Survival (OS).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Carboplatin & Paclitaxel & Radiation: Pelvic Radiation Therapy', 'description': 'Drug:Carboplatin and Paclitaxel and Radiation: Pelvic Radiation Therapy\n\nCarboplatin and Paclitaxel and Pelvic Radiation Therapy : Paclitaxel 175 mg/m2/3 hour \\& Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour \\& Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles\n\nCarboplatin and Paclitaxel and Radiation Therapy : Paclitaxel 175 mg/m2/3 hour \\& Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour \\& Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Drug:Carboplatin, Paclitaxel & Radiation', 'description': 'Drug:Carboplatin and Paclitaxel and Radiation: Pelvic Radiation Therapy\n\nCarboplatin and Paclitaxel and Pelvic Radiation Therapy : Paclitaxel 175 mg/m2/3 hour \\& Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour \\& Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles\n\nCarboplatin and Paclitaxel and Radiation Therapy : Paclitaxel 175 mg/m2/3 hour \\& Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour \\& Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000', 'lowerLimit': '43', 'upperLimit': '82'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '72', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'We considered 72 patients as baseline participants because they are the ones who completed the first three cycles of chemotherapy followed by at least partial RT. Of the 72 patients, 65 of them completed all prescribed regimen of treatment. This was the reason for the discrepancy.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-07', 'studyFirstSubmitDate': '2005-10-03', 'resultsFirstSubmitDate': '2020-02-27', 'studyFirstSubmitQcDate': '2005-10-03', 'lastUpdatePostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-07', 'studyFirstPostDateStruct': {'date': '2005-10-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Evaluate the Toxicity and Tolerability of Pelvic Radiation "Sandwiched" Between Cycles of Paclitaxel/Carboplatin Chemotherapy in Patients With UPSC', 'timeFrame': 'Up to 7 years', 'description': 'Overall survival analysis of early stage (stage 1 \\& 2) and late stage (stage 3 \\& 4)UPSC patients who were prescribed radiation "sanwhiched" between three cycles of paclitaxel/platinum chemotherapy before and after RT. Outcome measures were Progression Free Survival (PFS) and Overall Survival (OS).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Uterine Papillary Serous Carcinoma', 'UPSC', 'Radiation Therapy', 'Chemotherapy'], 'conditions': ['Uterine Cancer']}, 'referencesModule': {'references': [{'pmid': '22035806', 'type': 'RESULT', 'citation': 'Einstein MH, Frimer M, Kuo DY, Reimers LL, Mehta K, Mutyala S, Huang GS, Hou JY, Goldberg GL. Phase II trial of adjuvant pelvic radiation "sandwiched" between combination paclitaxel and carboplatin in women with uterine papillary serous carcinoma. Gynecol Oncol. 2012 Jan;124(1):21-5. doi: 10.1016/j.ygyno.2011.10.007. Epub 2011 Oct 27.'}]}, 'descriptionModule': {'briefSummary': 'Combination chemo/radiotherapy trials in advanced/recurrent endometrial cancer are ongoing. The optimal radiation modality, chemotherapeutic agents, and sequence of these regimens for the treatment of UPSC are yet to be established. A retrospective review of 16 patients treated at our institution with the sequential use of radiation "sandwiched" between paclitaxel/platinum chemotherapy found only one patient to have recurred at 16 months with a median follow-up of 15 months (range 6-33 months). The regimen was well tolerated. Eight of the sixteen patients (50%) developed grade 3 neutropenia following cycle 4 of chemotherapy, two of which required a 1 week treatment delay. There were no cases of grade 3 or 4 thrombocytopenia noted. There was no febrile neutropenia and no hospital admissions for toxicity. There were no observed grade 3 or 4 non-hematologic toxicities. With the median follow up of 15 months, we have not observed late toxicities.\n\nGiven these favorable preliminary findings, supported by recently published data documenting efficacy of the "sandwich" multimodality technique in other difficult uterine malignancies (malignant mixed mullerian tumors), we propose to study this combination of chemotherapy and radiation prospectively. Our aim is to better evaluate patterns of recurrence and possible benefits in progression-free and overall survival.', 'detailedDescription': 'Uterine papillary serous carcinoma (UPSC) is an uncommon, but aggressive variant of endometrial carcinoma that has a high recurrence rate and poor response to therapy. It has a propensity to metastasize throughout the abdomen, similar to serous carcinoma of the ovary. In fact, many patients with disease apparently confined to the uterus have microscopic intra-abdominal spread at the time of diagnosis. Recurrences are common both in the pelvis as well as in the upper abdomen.\n\nAfter staging and debulking of gross disease, adjuvant radiation therapy is recommended to treat patients with endometrial carcinoma at high risk for recurrent disease. High-risk features include histologic cell type, grade, depth of myometrial invasion, cervical extension, lymph-vascular invasion, adnexal involvement, intraperitoneal spread, positive peritoneal cytology, and positive lymph nodes. Pelvic radiation can limit local recurrences to less than 6.5%. However, approximately 25-30% of patients with high-risk features who receive radiation recur with distant metastases. Even patients treated with whole abdominal irradiation are at risk for extra-abdominal recurrences with progression-free intervals of 7 to 8 months.\n\nAdjuvant chemotherapeutic regimens have been studied in high-risk endometrial cancers, but none have demonstrated a survival advantage. Doxorubicin, in combination with platinum, has a reported 42% response rate, but a high toxicity profile. Paclitaxel has an overall response rate of 36% in patients with advanced and recurrent endometrial cancer. Platinum-based chemotherapies have a 28-42% response rate.\n\nRetrospective studies in patients with UPSC have demonstrated response rates of up to 35% in patients with multiagent chemotherapy. In one study, a median progression-free interval of 30 months was observed in patients treated with paclitaxel and platinum in the adjuvant and recurrent settings. Based on these findings and the similarities and clinical success of paclitaxel/platinum therapy in patients with ovarian serous carcinoma, this combination warrants further investigation in a prospective manner in patients with UPSC.\n\nCombination chemo/radiotherapy trials in advanced/recurrent endometrial cancer are ongoing. The optimal radiation modality, chemotherapeutic agents, and sequence of these regimens for the treatment of UPSC are yet to be established. A retrospective review of 16 patients treated at our institution with the sequential use of radiation "sandwiched" between paclitaxel/platinum chemotherapy found only one patient to have recurred at 16 months with a median follow-up of 15 months (range 6-33 months). The regimen was well tolerated. Eight of the sixteen patients (50%) developed grade 3 neutropenia following cycle 4 of chemotherapy, two of which required a 1 week treatment delay. There were no cases of grade 3 or 4 thrombocytopenia noted. There was no febrile neutropenia and no hospital admissions for toxicity. There were no observed grade 3 or 4 non-hematologic toxicities. With the median follow up of 15 months, we have not observed late toxicities.\n\nGiven these favorable preliminary findings, supported by recently published data documenting efficacy of the "sandwich" multimodality technique in other difficult uterine malignancies (malignant mixed mullerian tumors), we propose to study this combination of chemotherapy and radiation prospectively. Our aim is to better evaluate patterns of recurrence and possible benefits in progression-free and overall survival.\n\nSurrogate endpoint biomarkers such as ER/PR, HER2/Neu and p53 will be correlated with prognosis. In addition, fresh frozen tissue will be banked for future cDNA microarray analyses of UPSC tumors.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically documented uterine papillary serous carcinoma (UPSC) with no visible residual disease.\n2. Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node samplings.\n3. Age \\> 18 years.\n4. ECOG performance status of \\< 2.\n5. Written voluntary informed consent.\n\nExclusion Criteria:\n\n1. Patient has impairment of hepatic, renal or hematologic function as defined by the following baseline laboratory values:\n\n 1. Serum SGOT and /or SGPT \\> 2.5 times the institutional upper limit of normal\n 2. Total serum bilirubin \\> 1.5 mg/dl\n 3. History of chronic or active hepatitis\n 4. Serum creatinine \\> 2.0 mg/dl\n 5. Platelets \\< 100,000/mm3\n 6. Absolute neutrophil count (ANC) \\< 1500/mm3\n 7. Hemoglobin \\< 8.0 g/dl (the patient may be transfused prior to study entry)\n2. Patient has severe or uncontrolled concurrent medical disease (eg. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)\n3. Patient has been treated with myelosuppressive chemotherapy within three weeks prior to study entry.\n4. Patient with any prior chemotherapy or radiotherapy for pelvic malignancy.\n5. Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry.'}, 'identificationModule': {'nctId': 'NCT00231868', 'briefTitle': 'A Study of Radiation Therapy and Paclitaxel and Carboplatin in Patients With Uterine Papillary Serous Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'A Pilot Phase II Trial of Radiation Therapy "Sandwiched" Between Paclitaxel and Carboplatin in Patients With Uterine Papillary Serous Carcinoma', 'orgStudyIdInfo': {'id': '01-09-227'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Drug:Carboplatin and Paclitaxel and Radiation: Pelvic Radiation Therapy', 'interventionNames': ['Drug: Carboplatin and Paclitaxel and Pelvic Radiation Therapy', 'Procedure: Carboplatin and Paclitaxel and Pelvic Radiation Therapy', 'Drug: Carboplatin and Paclitaxel and Radiation Therapy']}], 'interventions': [{'name': 'Carboplatin and Paclitaxel and Pelvic Radiation Therapy', 'type': 'DRUG', 'description': 'Paclitaxel 175 mg/m2/3 hour \\& Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour \\& Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles', 'armGroupLabels': ['A']}, {'name': 'Carboplatin and Paclitaxel and Pelvic Radiation Therapy', 'type': 'PROCEDURE', 'description': 'Paclitaxel 175 mg/m2/3 hour \\& Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour \\& Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles', 'armGroupLabels': ['A']}, {'name': 'Carboplatin and Paclitaxel and Radiation Therapy', 'type': 'DRUG', 'description': 'Paclitaxel 175 mg/m2/3 hour \\& Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour \\& Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Mark H Einstein, M.D., M.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center and Albert Einstein College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending', 'investigatorFullName': 'Dennis Yi-Shin Kuo', 'investigatorAffiliation': 'Montefiore Medical Center'}}}}