Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-25 @ 2:16 PM
Study NCT ID:
NCT05384366
Status:
COMPLETED
Last Update Posted:
2022-05-20
First Post:
2022-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neoadjuvant Chemotherapy in Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'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': 'D020360', 'term': 'Neoadjuvant Therapy'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'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': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients with locally advanced carcinoma of the uterine cervix were recruited for assessment of clinical and pathological therapeutic response. Multivariate analysis was conducted to predict the independent predictors of response'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-19', 'studyFirstSubmitDate': '2022-05-16', 'studyFirstSubmitQcDate': '2022-05-19', 'lastUpdatePostDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Response', 'timeFrame': '21 days after completion of third cycles', 'description': 'Response to intervention by RACIST criteria 1.1'}, {'measure': 'Pathological response', 'timeFrame': '6 months', 'description': 'Pathological response after evaluation of surgical specimen and pathological staging'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer', 'cervix', 'neoadjuvant chemotherapy', 'predictors'], 'conditions': ['Cervix Cancer', 'Cervical Cancer', 'Cancer of the Uterine Cervix']}, 'referencesModule': {'references': [{'pmid': '12743137', 'type': 'BACKGROUND', 'citation': 'Rose PG. Combined-modality therapy of locally advanced cervical cancer. J Clin Oncol. 2003 May 15;21(10 Suppl):211s-217s. doi: 10.1200/JCO.2003.01.222.'}, {'pmid': '23640393', 'type': 'BACKGROUND', 'citation': 'Katsumata N, Yoshikawa H, Kobayashi H, Saito T, Kuzuya K, Nakanishi T, Yasugi T, Yaegashi N, Yokota H, Kodama S, Mizunoe T, Hiura M, Kasamatsu T, Shibata T, Kamura T; Japan Clinical Oncology Group. Phase III randomised controlled trial of neoadjuvant chemotherapy plus radical surgery vs radical surgery alone for stages IB2, IIA2, and IIB cervical cancer: a Japan Clinical Oncology Group trial (JCOG 0102). Br J Cancer. 2013 May 28;108(10):1957-63. doi: 10.1038/bjc.2013.179. Epub 2013 May 2.'}, {'pmid': '24431655', 'type': 'BACKGROUND', 'citation': 'Singh U, Ahirwar N, Rani AK, Singh N, Sankhwar P, Qureshi S. The efficacy and safety of neoadjuvant chemotherapy in treatment of locally advanced carcinoma cervix. J Obstet Gynaecol India. 2013 Aug;63(4):273-8. doi: 10.1007/s13224-012-0342-6. Epub 2013 Mar 12.'}, {'pmid': '25992238', 'type': 'BACKGROUND', 'citation': 'Osman M. The role of neoadjuvant chemotherapy in the management of locally advanced cervix cancer: a systematic review. Oncol Rev. 2014 Sep 23;8(2):250. doi: 10.4081/oncol.2014.250. eCollection 2014 Sep 23.'}, {'pmid': '9345358', 'type': 'BACKGROUND', 'citation': 'Sardi JE, Giaroli A, Sananes C, Ferreira M, Soderini A, Bermudez A, Snaidas L, Vighi S, Gomez Rueda N, di Paola G. Long-term follow-up of the first randomized trial using neoadjuvant chemotherapy in stage Ib squamous carcinoma of the cervix: the final results. Gynecol Oncol. 1997 Oct;67(1):61-9. doi: 10.1006/gyno.1997.4812.'}, {'pmid': '24825458', 'type': 'BACKGROUND', 'citation': 'Takatori E, Shoji T, Omi H, Kagabu M, Miura F, Takeuchi S, Kumagai S, Yoshizaki A, Sato A, Sugiyama T. Analysis of prognostic factors for patients with bulky squamous cell carcinoma of the uterine cervix who underwent neoadjuvant chemotherapy followed by radical hysterectomy. Int J Clin Oncol. 2015 Apr;20(2):345-50. doi: 10.1007/s10147-014-0702-6. Epub 2014 May 14.'}, {'pmid': '28187089', 'type': 'BACKGROUND', 'citation': 'Koensgen D, Sehouli J, Belau A, Weiss M, Stope MB, Grokopf V, Eichbaum M, Ledwon P, Lichtenegger W, Zygmunt M, Kohler G, Mustea A. Clinical Outcome of Neoadjuvant Radiochemotherapy in Locally Advanced Cervical Cancer: Results of an Open Prospective, Multicenter Phase 2 Study of the North-Eastern German Society of Gynecological Oncology. Int J Gynecol Cancer. 2017 Mar;27(3):500-506. doi: 10.1097/IGC.0000000000000894.'}, {'pmid': '27678502', 'type': 'BACKGROUND', 'citation': 'Di Donato V, Schiavi MC, Ruscito I, Visentin VS, Palaia I, Marchetti C, Fischetti M, Monti M, Muzii L, Benedetti Panici P. Effects of Neoadjuvant Chemotherapy Plus Radical Surgery as Front Line Treatment Strategy in Patients Affected by FIGO Stage III Cervical Cancer. Ann Surg Oncol. 2016 Dec;23(Suppl 5):841-849. doi: 10.1245/s10434-016-5597-1. Epub 2016 Sep 27.'}]}, 'descriptionModule': {'briefSummary': 'Cervical cancer represents the second commonest cancer in women worldwide, with 500,000 new cases and 300,000 deaths reported yearly. Among cervical cancer cases, 80% occur in developing countries and about 70% are identified as advanced cancer. According to the International Federation of Gynecology and Obstetrics (FIGO) staging system, a locally advanced cervical cancer includes stage IB2 to IIB.\n\nTreatment modalities include radical surgery with or without adjuvant radiotherapy (RT), Neoadjuvant Chemotherapy (NAC) plus radical hysterectomy with or without adjuvant RT, and concomitant chemo radiation. Currently, platinum based concurrent chemoradiotherapy is the gold standard for locally advanced cervical carcinoma.\n\nNeoadjuvant chemotherapy has many advantages: decreasing tumor size making surgery easier with improved rate of complete resection, decreased pelvic recurrence rate significantly, decreasing rate of parametrial invasion and lymph node metastasis, better brachytherapy distribution, minimal radiation toxicity, and 15% absolute increase of 5-year survival.\n\nThis study will evaluate various factors i.e. patient related (Age, Menopausal status, HPV, HIV, Comorbidities), Tumor related pathological stages (TNM), grade, lymphovascular perineural invasion, lymph nodes, extranodal extension, tumor margins including radial margin, type of tumor i.e. Adeno vs squamous, mutation profile and Treatment related factors (type of NAC, duration of NAC, no of cycles of NAC).', 'detailedDescription': "This is a single group prospective study to evaluate factors affecting treatment responses in uterine cervical carcinoma. All patients who will be receiving NAC followed by surgery will be included and assessed for various defined factors influencing response. Responses will be assessed by RECIST 1.1 criteria.\n\n1. All patients of cervical growth will be evaluated. Initial clinical evaluation, biopsy and if positive, HPV DNA status will be done. On confirmation of malignancy further staging will be done by FIGO Classification. Imaging will include contrast enhanced computed tomography (CECT) abdomen or Magnetic resonance imaging (MRI) pelvis and ultrasound (USG) abdomen. Routine blood investigations, chest X-ray (CXR) and Electrocardiography (ECG) will be done.\n2. In recruited patients, 3 cycles of NAC consisting of Paclitaxel (175 mg/m2) and Carboplatin (AUC5) at 21 day intervals were given.\n3. Adverse reactions if any were recorded as WHO toxicity grades.\n4. Evaluation of response was done after end of 2nd cycle of chemotherapy with clinical examination and Imaging (CT/MRI) by RECIST 1.1 criteria.\n5. Response was divided into two groups- 1) Complete/ Partial response 2) Poor response/ Stable disease/ Progressive disease. Patients with Poor response/ stable disease/ progressive disease will undergo concurrent chemoradiation (CCRT) while patients with partial/complete response will undergo Wertheim's hysterectomy.\n6. After surgery Pathological evaluation will include T, N, M, histological type, Lymphovascular invasion (LVI), Perineural invasion (PNI), Depth of Tumor Invasion, Extra nodal extension (ENE), Grade, (next generation sequencing (NGS)- Mutation Analysis.\n7. Post operative external pelvic irradiation was given according to Sedlis criteria in node negative, margin negative, parametria negative cases.\n8. Follow up Evaluation was done at 1, 3 \\& 6 months by clinical examination, Biopsy for any recurrence and Imaging (CECT or MRI pelvis) at 6 months. Follow up was continued every 3 months thereof."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'The disease occurs only in females', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • All patients receiving NACT followed by Surgery/RT and willing to give consent will be included in study\n\n * FIGO Stage Ib/ IIa/ IIb\n * Age more than 18 yrs\n\nExclusion Criteria:\n\n* • FIGO Stage Ia/ III/ IV\n\n * Patients who received treatment earlier\n * Pregnant/ lactating women\n * Second primary cancer'}, 'identificationModule': {'nctId': 'NCT05384366', 'briefTitle': 'Neoadjuvant Chemotherapy in Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Banaras Hindu University'}, 'officialTitle': 'To Study the Factors Affecting Treatment Responses in Patients With Uterine Cervical Carcinoma Undergoing Neoadjuvant Chemotherapy', 'orgStudyIdInfo': {'id': 'NeoCx'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Neoadjuvant chemotherapy', 'description': 'Patients receiving neoadjuvant paclitaxel 175mg/m2 and carboplatin (AUC5) at three weekly interval by intravenous route', 'interventionNames': ['Drug: Neoadjuvant chemotherapy']}], 'interventions': [{'name': 'Neoadjuvant chemotherapy', 'type': 'DRUG', 'otherNames': ['Paclitaxel and Carboplatin'], 'description': 'doublet of taxane and carboplatin', 'armGroupLabels': ['Neoadjuvant chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '221005', 'city': 'Varanasi', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'Banaras Hindu University', 'geoPoint': {'lat': 25.31668, 'lon': 83.01041}}], 'overallOfficials': [{'name': 'Manoj Pandey, MS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Banaras Hindu University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': '6 months', 'ipdSharing': 'YES', 'description': 'On request', 'accessCriteria': 'on request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Banaras Hindu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Manoj Pandey', 'investigatorAffiliation': 'Banaras Hindu University'}}}}