Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-01 @ 1:02 AM
Study NCT ID:
NCT01330056
Status:
COMPLETED
Last Update Posted:
2019-07-09
First Post:
2011-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Organ Preservation Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007818', 'term': 'Laryngeal Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 264}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-08', 'studyFirstSubmitDate': '2011-04-04', 'studyFirstSubmitQcDate': '2011-04-05', 'lastUpdatePostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Organ preservation rate', 'timeFrame': '2 years', 'description': 'The larynge and pharyngeal functions are compared between two groups. The time frame may be extended to 5 years.'}], 'secondaryOutcomes': [{'measure': 'Survival rate', 'timeFrame': '2 years', 'description': 'The time frame may be extended to 5 years.'}, {'measure': 'Locoregional control rate', 'timeFrame': '2 years', 'description': 'The time frame may be extended to 5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Laryngeal and pharyngeal preservation, survivals'], 'conditions': ['Organ Preservation']}, 'descriptionModule': {'briefSummary': 'This is a prospective randomized controlled trial comparing functional organ preservation surgery (FOPS) vs. radiotherapy or chemoradiotherapy as the first treatment modality for patients with head an neck squamous cell carcinoma arising in the oropharynx, larynx and hypopharynx. This study has a hypothesis that the FOPS is an effective treatment strategy to preserve the organ function without compromising oncologic safety and survival.', 'detailedDescription': 'This prospective study compare the following items between two groups:\n\n* Functional outcomes: laryngeal, pharyngeal, and quality of life\n* Oncological outcomes: survivals, locoregional controls\n* Combined imaging and molecular biomarkers with follow-up data\n\nThe functional organ preservation surgery (FOPS) is defined as a surgery preserving the laryngeal or pharyngeal function regardless of open or transoral route. The FOPS may include:\n\n* Radical tonsillectomy or other oropharyngeal resection\n* Partial laryngectomy or pharyngectomy\n* Transoral laser microresection\n* Transoral robotic surgery (TORS)\n* Reconstructive surgery may be combined with primary resection\n* Neck dissection may be indicated in some patients\n* Postoperative radiotherapy or chemoradiotherapy may be indicated in some patients according to their pathologic reports.\n\nThe standard concurrent chemoradiotherapy (CRT) is generally used but radiotherapy (RT) alone may be indicated for some patients under tumor-board discussion. The salvage surgery may be indicated for patients with residual or recurrent diseases after CRT or RT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with squamous cell carcinomas arising in the oropharynx, larynx, or hypopharynx\n* Resectable tumors without distant metastases\n* age range: 18-80 years\n* Pretreatment Karnofsky performance scale \\> or 70%\n* Operable patients\n* No significant loss of pretreatment larynx and pharyngeal functions\n\nExclusion Criteria:\n\n* Patients with a present or previous history of other cancers except benign tumors, premalignant lesions, carcinoma-in-situ (at some organ sites), well-differentiated thyroid carcinoma and low-grade salivary gland cancers (from tumor-board decision whether the tumors significantly affect the survival outcomes)\n* Other organ-site cancers\n* Low-performance status or non-operable patients\n* Non-resectable or distant-metastatic tumors\n* Extensive primary or neck nodal diseases\n* Significant pretreament loss of laryngeal or pharyngeal functions\n* cT1N0 glottic carcinomas'}, 'identificationModule': {'nctId': 'NCT01330056', 'acronym': 'FOPS', 'briefTitle': 'Functional Organ Preservation Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'A Prospective Randomized Controlled Trial of Functional Organ Preservation Surgery vs. Chemoradiotherapy for Head and Neck Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': '2010-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'FOPS', 'description': '* Functional organ preservation surgery (FOPS) group as a first-line treatment modality\n* Postoperative RT or CRT may be included for the patients of this group', 'interventionNames': ['Procedure: FOPS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CRT', 'description': '* Concurrent chemoradiotherapy or radiotherapy group as a first-line treatment modality\n* Salvage surgery may be applied for the patients for persistent or recurrent cancers after CRT or RT', 'interventionNames': ['Radiation: CRT']}], 'interventions': [{'name': 'FOPS', 'type': 'PROCEDURE', 'description': '* Functional organ preservation (FOPS) as a first-line treatment modality\n* Postoperative RT or CRT may be included for the patients of this group.', 'armGroupLabels': ['FOPS']}, {'name': 'CRT', 'type': 'RADIATION', 'description': '* Concurrent chemoradiotherapy as a first-line treatment modality\n* Salvage surgery may be applied for the patients with persistent or recurrent cancers after RT or CRT', 'armGroupLabels': ['CRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jong-Lyel Roh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Jong-Lyel Roh', 'investigatorAffiliation': 'Asan Medical Center'}}}}