Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-01-01 @ 9:18 AM
Study NCT ID:
NCT01710956
Status:
UNKNOWN
Last Update Posted:
2012-10-19
First Post:
2012-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Once Daily Accelerated Fractionation With Concomitant Boost to the Gross Tumor Volume Compared With Twice Daily Hyperfractionation in Concurrent Chemoradiation in Patients With Limited Disease Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-10-17', 'studyFirstSubmitDate': '2012-10-16', 'studyFirstSubmitQcDate': '2012-10-17', 'lastUpdatePostDateStruct': {'date': '2012-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': '5years after chemoradiotherapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['concurrent chemoradiation in patients with limited disease small cell lung cancer'], 'conditions': ['Limited Disease Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Non-small cell lung cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically (if cannot be proven histologically, at least twice positive findings on fine needle aspiration or sputum cytology) confirmed SCLC\n* Limited stage (Clinical stage I-IIIb, lesion limited to one side of thorax, e.g. Excluding T4 disease with malignant pleural effusion or N3 disease with contralateral hilum/supraclavicular lymph node invasion).\n* Measurable or assessable lesion\n* Age over 18 years old\n* Performance status (ECOG scale): 0\\~2\n* Adequate organ functions: ANC ≥ 1500/ul, PLT ≥ 100 x 103/u, Total Bilirubin ≤ 1.5 mg/dl, Creatinine ≤ 1.5 mg/dl\n* Inclusion of tumor within the limited radiation field without significant loss of pulmonary function (confirmed by radiation oncologist)\n* Sexually active fertile men and women using a contraceptive method\n* Patients should sign a written informed consest before study entry\n\nExclusion Criteria:\n\n* T4 disease with malignant pleural effusion; N3 disease with contralateral hilum/supraclavicular lymph node invasion\n* Lesion with mixed small cell nonsmall cell feature (pathologically)\n* prior chemotherapy or radiation therapy.\n* Pericardial or pleural effusion on chest X-ray image regardless of cytological finding\n* T4 disease with tumor invasion to great vessels, heart, trachea, or esophagus; Concerns about possible perforation by tumor necrosis\n* Severe comorbidities such as cardiac disease with symptom, myocardiac infarction within 6 months, chronic obstructive pulmonary disease with FEV1 less than 1.0ℓ, or uncontrolled bronchospasm of unaffected lung\n* With atelectasis that makes GTV unidentifiable\n* Other primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 3 years ago without recurrence)\n* Uncontrolled psychiatric disorder, serious head injury, chronic alcoholism, drug addiction and central nervous system disease'}, 'identificationModule': {'nctId': 'NCT01710956', 'briefTitle': 'Once Daily Accelerated Fractionation With Concomitant Boost to the Gross Tumor Volume Compared With Twice Daily Hyperfractionation in Concurrent Chemoradiation in Patients With Limited Disease Small Cell Lung Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Center, Korea'}, 'officialTitle': 'Randomized Phase II Study of Once Daily Accelerated Fractionation With Concomitant Boost to the Gross Tumor Volume Compared With Twice Daily Hyperfractionation in Concurrent Chemoradiation in Patients With Limited Disease Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'NCCCTS-11-531'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1(with twice-daily TRT)', 'interventionNames': ['Radiation: Arm 1: with twice-daily thoracic radiotherapy/ Arm 2: with once-daily thoracic radiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2 (with once-daily TRT)', 'interventionNames': ['Radiation: Arm 1: with twice-daily thoracic radiotherapy/ Arm 2: with once-daily thoracic radiotherapy']}], 'interventions': [{'name': 'Arm 1: with twice-daily thoracic radiotherapy/ Arm 2: with once-daily thoracic radiotherapy', 'type': 'RADIATION', 'description': 'Arm 1: with twice-daily thoracic radiotherapy daily 1.5gy/fr. bid, total 45gy(30fr during 3weeks) Arm 2: with once-daily thoracic radiotherapy daily 2.4gy/fr. qd, total 60gy(25fr during 5weeks)', 'armGroupLabels': ['Arm 1(with twice-daily TRT)', 'Arm 2 (with once-daily TRT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410-769', 'city': 'Ilsan-ro 323, Ilsandoung-gu, Goyang-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kwan Ho Cho, M.D.', 'role': 'CONTACT', 'email': 'ncckrog@ncc.re.kr', 'phone': '+82 31 920 1720'}, {'name': 'Sung Ho Moon, M.D.', 'role': 'CONTACT', 'email': 'ncckrog@ncc.re.kr', 'phone': '+82 31 920 1726'}, {'name': 'Sung Ho Moon, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jin Soo Lee, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Heung Tae Kim, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ji Youn Han, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tak Yun, M.D', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Young Joo Lee, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Geon Kook Lee, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hyae Young Kim, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Byung Ho Nam, Statistician', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'National Cancer Canter, Korea', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'zip': '410-769', 'city': 'Ilsan-ro 323, Ilsandoung-gu, Goyang-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kwan Ho Cho, M.D.', 'role': 'CONTACT', 'email': 'kwancho@ncc.re.kr', 'phone': '+82 31 920 1720'}, {'name': 'Sung Ho Moon, M.D.', 'role': 'CONTACT', 'email': 'shmoon@ncc.re.kr', 'phone': '+82 31 920 1726'}, {'name': 'Sung Ho Moon, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jin Soo Lee, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Heung Tae Kim, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ji Youn Han, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tak Yun, M.D', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Young Joo Lee, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'National Cancer Canter, Korea', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}], 'centralContacts': [{'name': 'Kwan Ho Cho, M.D.', 'role': 'CONTACT', 'email': 'kwancho@ncc.re.kr', 'phone': '+82 31 920 1720'}, {'name': 'Sung Ho Moon, M.D.', 'role': 'CONTACT', 'email': 'shmoon@ncc.re.kr', 'phone': '+82 31 920 1726'}], 'overallOfficials': [{'name': 'Kwan Ho Cho, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Center, Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Kwan Ho Cho', 'investigatorAffiliation': 'National Cancer Center, Korea'}}}}