Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2025-12-25 @ 4:42 PM
Study NCT ID:
NCT07249957
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reducing Radiation Target Volume for Stage IIb Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-10-10', 'size': 97844, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-11T04:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-09-18', 'studyFirstSubmitQcDate': '2025-11-18', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1."Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0" 2."Therapeutic Effect as Assessed by RECIST1.1"', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stage IIb Cervical Cancer Radical Radiotherapy']}, 'descriptionModule': {'briefSummary': 'This is a domestic single-center prospective clinical trial. The study selected patients with histologically confirmed cervical squamous cell carcinoma, diagnosed as stage IIb according to the FIGO 2018 staging principle (tumor size \\< 4 cm). The patients first received 6 cycles of induction chemotherapy (carboplatin (AUC2) + paclitaxel (80 mg/m2), q1w), followed by concurrent chemoradiotherapy with a platinum-based regimen. The external beam radiation field only covered the entire uterus (including the primary lesion of the cervix), the bilateral parametrium, and the lesion of the cervix/vagina extending 3 cm downward. A total of 60 participants are planned to be included in the study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The patient voluntarily participated in this study and signed the informed consent form;\n2. Age range: 50 to 75 years old;\n3. Patients with cervical cancer who had not undergone surgery or chemotherapy and were initially diagnosed with squamous cell carcinoma by pathological histology, and were HPV high-risk positive;\n4. According to the 2018 International Federation of Gynecology and Obstetrics (FIGO) staging system, it was stage IIb (tumor size \\< 4 cm);\n5. ECOG score: 0 to 1, with an expected survival of more than 6 months;\n6. Pregnant women must undergo a pregnancy test (serum or urine) 7 days before enrollment, and the result must be negative, and they are willing to use appropriate contraceptive methods during the trial;\n7. According to the investigator's judgment, there are no absolute contraindications to radiotherapy and chemotherapy or surgery, and they can comply with the trial protocol.\n\nExclusion Criteria:\n\n1. Active or uncontrolled severe infections;\n2. Cirrhosis, decompensated liver disease;\n3. History of immunodeficiency, including HIV positive or having other acquired congenital immune deficiency diseases;\n4. Chronic renal insufficiency and renal failure;\n5. Patients with other malignancies that require treatment and/or newly diagnosed within 5 years;\n6. Myocardial infarction, severe arrhythmia, and ≥ grade 2 congestive heart failure (NYHA classification);\n7. Patients who have undergone pelvic artery embolization;\n8. Patients who have received radiotherapy for pelvic malignant tumors in the past;\n9. Patients who have received partial hysterectomy or radical hysterectomy in the past;\n10. Patients with a history of severe allergic reaction to platinum-based chemotherapy drugs;\n11. Comorbidities, requiring the use of drugs that cause significant liver and kidney damage during treatment, such as tuberculosis, etc.;\n12. Patients who cannot understand the experimental content and cannot cooperate, or who refuse to sign the informed consent form;\n13. Patients with serious accompanying diseases or other special conditions that seriously endanger their safety or affect their ability to complete the study."}, 'identificationModule': {'nctId': 'NCT07249957', 'briefTitle': 'Reducing Radiation Target Volume for Stage IIb Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Chongqing University Cancer Hospital'}, 'officialTitle': 'Reducing Radiation Target Volume in Radical Radiotherapy for Stage IIb Cervical Cancer: A Single-arm Exploratory Study', 'orgStudyIdInfo': {'id': 'CQGOG0116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radical radiotherapy for IIb cervical cancer to reduce the irradiation area', 'interventionNames': ['Radiation: The external irradiation area only covers the entire uterus (including the primary lesion in the cervix), bilateral parametrium, and 3 cm below the cervical/vaginal lesions.']}], 'interventions': [{'name': 'The external irradiation area only covers the entire uterus (including the primary lesion in the cervix), bilateral parametrium, and 3 cm below the cervical/vaginal lesions.', 'type': 'RADIATION', 'description': 'The external irradiation area only covers the entire uterus (including the primary lesion in the cervix), bilateral parametrium, and 3 cm below the cervical/vaginal lesions.', 'armGroupLabels': ['Radical radiotherapy for IIb cervical cancer to reduce the irradiation area']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chongqing University Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Dept. of Gynecological Oncology Chongqing University Cancer Hospital', 'investigatorFullName': 'Dongling Zou', 'investigatorAffiliation': 'Chongqing University Cancer Hospital'}}}}