Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
Study NCT ID:
NCT01166204
Status:
COMPLETED
Last Update Posted:
2017-05-23
First Post:
2010-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone With Intensity-modulated Radiotherapy (IMRT) for Non Small Cell Lung Cancer (NSCLC) to an Individualised Mean Lung Dose (MLD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-22', 'studyFirstSubmitDate': '2010-07-19', 'studyFirstSubmitQcDate': '2010-07-19', 'lastUpdatePostDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '2.3 and 5 years'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '2.3 and 5 years'}, {'measure': 'Dyspnea (CTCAE 4.0)', 'timeFrame': '2.3 and 5 years'}, {'measure': 'Dysphagia (CTCAE 4.0)', 'timeFrame': '2.3 and 5 years'}, {'measure': 'Patterns of recurrence', 'timeFrame': '2.3 and 5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Radiotherapy', 'NSCLC'], 'conditions': ['Stage I-III Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Our group has shown that increasing the radiation dose to pre-specified normal tissue dose constraints could lead to increased TCP with the same NTCP in patients with non-concurrent and concurrent chemo-radiation. Here, the investigators want to investigate its efficacy in a prospective study in patients with stage I-III NSCLC, who are selected for high-dose radiotherapy with or without chemotherapy, but treated with IMRT. The latter technique has become standard, but the patterns of recurrence and the possibility for dose-escalation in an individualised setting have never been investigated properly.', 'detailedDescription': 'Eligible patients (see below) will receive radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes to an MLD (Mean Lung Dose) of 20 +/-1Gy, irrespective of lung function.\n\nOther dose-constraints: spinal cord max: 54Gy, brachial plexus (Dmax):66Gy\n\nIn concurrence with chemotherapy, radiotherapy will be delivered as follows:\n\n* First three weeks/30 fractions: twice-daily fractions of 1.5Gy, with 8h to 10h as interfraction interval, 5 days per week. Total dose: 45Gy/30 fractions\n* Thereafter: once daily fractions of 2.0Gy, 5 days per week until the target dose has been reached.\n\nIn sequential or radiotherapy alone schedules, twice-daily 1.8Gy with an interfraction interval of at least 8h will be delivered.\n\nThe radiation doses will be specified according to ICRU 50. Lung density corrections will be applied, as well as all standard QA procedures. Technical requirements are the same as in standard practice at MAASTRO clinic\n\nChemotherapy schedules allowed:\n\n1. 1-2 cycles induction chemotherapy: any third generation schedule is allowed. The type will be registered.\n2. Concurrent part: (day 1 = first day of radiotherapy)\n\n * cisplatin - vinorelbine\n * cisplatin - docetaxel\n * cisplatin - etoposide\n * cisplatin - pemetrexed in non-squamous histologies Q 3 weeks; 3 cycles\n\nWhen the calculated creatinin clearance is less than 60ml/min, cisplatin may be substituted for carboplatin'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological or cytological proven NSCLC\n* IUCC stage I-III, or solitary metastases (\\<6), which are amendable for radical local treatment.\n* Performance status 0-2\n* IMRT technique\n\nExclusion Criteria:\n\n* Not NSCLC or mixed NSCLC and other histologies (e.g. small cell carcinoma)\n* Stage IV, except for solitary (\\<6) metastases\n* Performance status 3 or more\n* No IMRT technique'}, 'identificationModule': {'nctId': 'NCT01166204', 'briefTitle': 'Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone With Intensity-modulated Radiotherapy (IMRT) for Non Small Cell Lung Cancer (NSCLC) to an Individualised Mean Lung Dose (MLD)', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht Radiation Oncology'}, 'officialTitle': 'Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone With IMRT for Stage I-III Non-small Cell Lung Cancer to an Individualised MLD', 'orgStudyIdInfo': {'id': 'BRONC CONCURR MLD/BRONC MLD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single group', 'interventionNames': ['Radiation: Radiotherapy']}], 'interventions': [{'name': 'Radiotherapy', 'type': 'RADIATION', 'description': 'Radiotherapy', 'armGroupLabels': ['Single group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6229 ET', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'MAASTRO clinic', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht Radiation Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}