Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-02-24 @ 7:01 PM
Study NCT ID:
NCT04409860
Status:
RECRUITING
Last Update Posted:
2023-04-11
First Post:
2020-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical 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': 'D009369', 'term': 'Neoplasms'}, {'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': 'D019370', 'term': 'Observation'}, {'id': 'C111043', 'term': 'TP protocol'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2029-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-08', 'studyFirstSubmitDate': '2020-05-23', 'studyFirstSubmitQcDate': '2020-05-28', 'lastUpdatePostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': '2 years', 'description': 'Progression-free survival'}], 'secondaryOutcomes': [{'measure': 'OS', 'timeFrame': '5 years', 'description': '5 years overall survival'}, {'measure': 'ORR', 'timeFrame': '3 months', 'description': 'To evaluate the objective response rate(CR+PR) of adjuvant chemotherapy in cervical cancer'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Locally adcanced', 'CCRT', 'Adjuvant chemotherapy'], 'conditions': ['Cervical Cancer']}, 'referencesModule': {'references': [{'pmid': '23510764', 'type': 'BACKGROUND', 'citation': 'de Sanjose S, Serrano B, Castellsague X, Brotons M, Munoz J, Bruni L, Bosch FX. Human papillomavirus (HPV) and related cancers in the Global Alliance for Vaccines and Immunization (GAVI) countries. A WHO/ICO HPV Information Centre Report. Vaccine. 2012 Nov 20;30 Suppl 4:D1-83, vi. doi: 10.1016/S0264-410X(12)01435-1. No abstract available.'}, {'pmid': '27619255', 'type': 'BACKGROUND', 'citation': 'Verma J, Monk BJ, Wolfson AH. New Strategies for Multimodality Therapy in Treating Locally Advanced Cervix Cancer. Semin Radiat Oncol. 2016 Oct;26(4):344-8. doi: 10.1016/j.semradonc.2016.05.003. Epub 2016 May 26.'}, {'pmid': '11803143', 'type': 'BACKGROUND', 'citation': 'Rose PG. Chemoradiotherapy for cervical cancer. Eur J Cancer. 2002 Jan;38(2):270-8. doi: 10.1016/s0959-8049(01)00352-5.'}, {'pmid': '19001332', 'type': 'BACKGROUND', 'citation': 'Chemoradiotherapy for Cervical Cancer Meta-Analysis Collaboration. Reducing uncertainties about the effects of chemoradiotherapy for cervical cancer: a systematic review and meta-analysis of individual patient data from 18 randomized trials. J Clin Oncol. 2008 Dec 10;26(35):5802-12. doi: 10.1200/JCO.2008.16.4368. Epub 2008 Nov 10.'}, {'pmid': '23564812', 'type': 'BACKGROUND', 'citation': 'Chereau E, DE LA Hosseraye C, Ballester M, Monnier L, Rouzier R, Touboul E, Darai E. The role of completion surgery after concurrent radiochemotherapy in locally advanced stages IB2-IIB cervical cancer. Anticancer Res. 2013 Apr;33(4):1661-6.'}, {'pmid': '17531428', 'type': 'BACKGROUND', 'citation': 'Carcopino X, Houvenaeghel G, Buttarelli M, Esterni B, Tallet A, Goncalves A, Jacquemier J. Equivalent survival in patients with advanced stage IB-II and III-IVA cervical cancer treated by adjuvant surgery following chemoradiotherapy. Eur J Surg Oncol. 2008 May;34(5):569-75. doi: 10.1016/j.ejso.2007.04.006. Epub 2007 May 25.'}, {'pmid': '24183796', 'type': 'BACKGROUND', 'citation': 'Hequet D, Marchand E, Place V, Fourchotte V, De La Rochefordiere A, Dridi S, Coutant C, Lecuru F, Bats AS, Koskas M, Bretel JJ, Bricou A, Delpech Y, Barranger E. Evaluation and impact of residual disease in locally advanced cervical cancer after concurrent chemoradiation therapy: results of a multicenter study. Eur J Surg Oncol. 2013 Dec;39(12):1428-34. doi: 10.1016/j.ejso.2013.10.006. Epub 2013 Oct 23.'}, {'pmid': '20817228', 'type': 'BACKGROUND', 'citation': 'Ferrandina G, Margariti PA, Smaniotto D, Petrillo M, Salerno MG, Fagotti A, Macchia G, Morganti AG, Cellini N, Scambia G. Long-term analysis of clinical outcome and complications in locally advanced cervical cancer patients administered concomitant chemoradiation followed by radical surgery. Gynecol Oncol. 2010 Dec;119(3):404-10. doi: 10.1016/j.ygyno.2010.08.004.'}, {'pmid': '19555996', 'type': 'BACKGROUND', 'citation': 'Colombo PE, Bertrand MM, Gutowski M, Mourregot A, Fabbro M, Saint-Aubert B, Quenet F, Gourgou S, Kerr C, Rouanet P. Total laparoscopic radical hysterectomy for locally advanced cervical carcinoma (stages IIB, IIA and bulky stages IB) after concurrent chemoradiation therapy: surgical morbidity and oncological results. Gynecol Oncol. 2009 Sep;114(3):404-9. doi: 10.1016/j.ygyno.2009.05.043. Epub 2009 Jun 24.'}, {'pmid': '16406062', 'type': 'BACKGROUND', 'citation': 'Houvenaeghel G, Lelievre L, Rigouard AL, Buttarelli M, Jacquemier J, Viens P, Gonzague-Casabianca L. Residual pelvic lymph node involvement after concomitant chemoradiation for locally advanced cervical cancer. Gynecol Oncol. 2006 Jul;102(1):74-9. doi: 10.1016/j.ygyno.2005.11.037. Epub 2006 Jan 10.'}, {'pmid': '17156969', 'type': 'BACKGROUND', 'citation': 'Houvenaeghel G, Lelievre L, Buttarelli M, Jacquemier J, Carcopino X, Viens P, Gonzague-Casabianca L. Contribution of surgery in patients with bulky residual disease after chemoradiation for advanced cervical carcinoma. Eur J Surg Oncol. 2007 May;33(4):498-503. doi: 10.1016/j.ejso.2006.10.011. Epub 2006 Dec 6.'}, {'pmid': '16814371', 'type': 'BACKGROUND', 'citation': 'Vrdoljak E, Omrcen T, Novakovic ZS, Jelavic TB, Prskalo T, Hrepic D, Hamm W. Concomitant chemobrachyradiotherapy with ifosfamide and cisplatin followed by consolidation chemotherapy for women with locally advanced carcinoma of the uterine cervix--final results of a prospective phase II-study. Gynecol Oncol. 2006 Nov;103(2):494-9. doi: 10.1016/j.ygyno.2006.03.060. Epub 2006 Jun 30.'}, {'pmid': '19661184', 'type': 'BACKGROUND', 'citation': 'Domingo E, Lorvidhaya V, de Los Reyes R, Syortin T, Kamnerdsupaphon P, Lertbutsayanukul C, Vito-Cruz E, Tharavichitkul E, Jin K, Yoshihara M, Cupino N, Lertsanguansinchai P. Capecitabine-based chemoradiotherapy with adjuvant capecitabine for locally advanced squamous carcinoma of the uterine cervix: phase II results. Oncologist. 2009 Aug;14(8):828-34. doi: 10.1634/theoncologist.2009-0041. Epub 2009 Aug 6.'}, {'pmid': '21075554', 'type': 'BACKGROUND', 'citation': 'Choi CH, Lee YY, Kim MK, Kim TJ, Lee JW, Nam HR, Huh SJ, Lee JH, Bae DS, Kim BG. A matched-case comparison to explore the role of consolidation chemotherapy after concurrent chemoradiation in cervical cancer. Int J Radiat Oncol Biol Phys. 2011 Dec 1;81(5):1252-7. doi: 10.1016/j.ijrobp.2010.07.2006. Epub 2010 Nov 13.'}, {'pmid': '20207507', 'type': 'BACKGROUND', 'citation': 'Zhang MQ, Liu SP, Wang XE. Concurrent chemoradiotherapy with paclitaxel and nedaplatin followed by consolidation chemotherapy in locally advanced squamous cell carcinoma of the uterine cervix: preliminary results of a phase II study. Int J Radiat Oncol Biol Phys. 2010 Nov 1;78(3):821-7. doi: 10.1016/j.ijrobp.2009.08.069. Epub 2010 Mar 6.'}, {'pmid': '21444871', 'type': 'BACKGROUND', 'citation': 'Duenas-Gonzalez A, Zarba JJ, Patel F, Alcedo JC, Beslija S, Casanova L, Pattaranutaporn P, Hameed S, Blair JM, Barraclough H, Orlando M. Phase III, open-label, randomized study comparing concurrent gemcitabine plus cisplatin and radiation followed by adjuvant gemcitabine and cisplatin versus concurrent cisplatin and radiation in patients with stage IIB to IVA carcinoma of the cervix. J Clin Oncol. 2011 May 1;29(13):1678-85. doi: 10.1200/JCO.2009.25.9663. Epub 2011 Mar 28.'}, {'pmid': '22307061', 'type': 'BACKGROUND', 'citation': 'Tang J, Tang Y, Yang J, Huang S. Chemoradiation and adjuvant chemotherapy in advanced cervical adenocarcinoma. Gynecol Oncol. 2012 May;125(2):297-302. doi: 10.1016/j.ygyno.2012.01.033. Epub 2012 Jan 31.'}, {'pmid': '12654431', 'type': 'BACKGROUND', 'citation': 'Lorvidhaya V, Chitapanarux I, Sangruchi S, Lertsanguansinchai P, Kongthanarat Y, Tangkaratt S, Visetsiri E. Concurrent mitomycin C, 5-fluorouracil, and radiotherapy in the treatment of locally advanced carcinoma of the cervix: a randomized trial. Int J Radiat Oncol Biol Phys. 2003 Apr 1;55(5):1226-32. doi: 10.1016/s0360-3016(02)04405-x.'}, {'pmid': '31074236', 'type': 'BACKGROUND', 'citation': 'Tangjitgamol S, Tharavichitkul E, Tovanabutra C, Rongsriyam K, Asakij T, Paengchit K, Sukhaboon J, Penpattanagul S, Kridakara A, Hanprasertpong J, Chomprasert K, Wanglikitkoon S, Atjimakul T, Pariyawateekul P, Katanyoo K, Tanprasert P, Janweerachai W, Sangthawan D, Khunnarong J, Chottetanaprasith T, Supawattanabodee B, Lertsanguansinchai P, Srisomboon J, Isaranuwatchai W, Lorvidhaya V. A randomized controlled trial comparing concurrent chemoradiation versus concurrent chemoradiation followed by adjuvant chemotherapy in locally advanced cervical cancer patients: ACTLACC trial. J Gynecol Oncol. 2019 Jul;30(4):e82. doi: 10.3802/jgo.2019.30.e82. Epub 2019 Apr 10.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this trial was to evaluate the efficacy of adjuvant chemotherapy in the locally advanced cervical cancer with residual lesions after concurrent chemoradiation therapy.', 'detailedDescription': '1. Objective:\n\n To compare response rate and survivals of locally advanced stage cervical cancer patients with residual lesions who had CCRT alone to those who had adjuvant chemotherapy after CCRT.\n2. Patients:\n\n 1. Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma\n 2. Complete CCRT(Radiation Does: A point 85Gy(+/-10%), B点50Gy(+/-10%), concurrent platinum-containing chemotherapy（cisplatin or carboplatin）\n 3. MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm).\n3. Methods:\n\nThe patients who have residual lesions after CCRT are randomized to arm A by observation or arm B by adjuvant chemotherapy with paclitaxel plus cisplatin every 3 weeks for 3 cycles.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma\n2. Complete CCRT(Radiation Does: A point 85Gy(+/-10%)，B点50Gy(+/-10%)，concurrent platinum-containing chemotherapy (cisplatin or carboplatin))\n3. MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm).\n4. ECOG\\<2\n5. Expected survival is longer than six months\n6. Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L\n7. ALT and AST≤2×ULN, Serum creatinine≤1.5×ULN\n8. The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial\n\nExclusion Criteria:\n\n1. Activity or uncontrol severe infection\n2. Liver cirrhosis, Decompensated liver disease\n3. History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease\n4. Patients who cannot tolerate chemotherapy because of chronic renal insufficiency or renal failure\n5. Have suffered or combined with other malignant tumor\n6. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure\n7. A history targeted therapy or pelvic artery embolization\n8. Artery-enous thrombosis within 6 months\n9. Patients with autoimmune diseases\n10. Complications, need to be treatment with drugs which may lead to liver or kidney injury\n11. Patients with disease progression after chemoradiation'}, 'identificationModule': {'nctId': 'NCT04409860', 'acronym': 'CQGOG0102', 'briefTitle': 'The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Chongqing University Cancer Hospital'}, 'officialTitle': 'Randomized Controlled Trial of the Efficacy of Adjuvant Chemotherapy in Patients With Residual Lesions After Concurrent Radiochemotherapy for Locally Advanced Cervical Cancer', 'orgStudyIdInfo': {'id': 'CQGOG0102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'In this group, observation is given after CCRT.', 'interventionNames': ['Radiation: CCRT']}, {'type': 'EXPERIMENTAL', 'label': 'trial group', 'description': 'In this group, adjuvant chemotherapy is given after CCRT.', 'interventionNames': ['Radiation: CCRT', 'Drug: Paclitaxel, Cisplatin']}], 'interventions': [{'name': 'CCRT', 'type': 'RADIATION', 'otherNames': ['control group: CCRT + observation'], 'description': 'Radiation concurrent platinum-containing chemotherapy (cisplatin or carboplatin)', 'armGroupLabels': ['control group', 'trial group']}, {'name': 'Paclitaxel, Cisplatin', 'type': 'DRUG', 'otherNames': ['trial group: CCRT + adjuvant chemotherapy'], 'description': 'The regimen of adjuvant chemotherapy following CCRT is Paclitaxel(150mg/m2 D1), Cisplatin(60mg/m2 D1) , q3w, three cycles.', 'armGroupLabels': ['trial group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400030', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dongling Zou, M.D.', 'role': 'CONTACT', 'email': 'cqzl_zdl@163.com', 'phone': '13657690699'}, {'name': 'Dongling Zou, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chongqing Cancer Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Dongling Zou, M.D.', 'role': 'CONTACT', 'email': 'cqzl_zdl@163.com', 'phone': '13657690699'}], 'overallOfficials': [{'name': 'Dongling Zou, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chongqing University Cancer Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chongqing University Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Director', 'investigatorFullName': 'Dongling Zou', 'investigatorAffiliation': 'Chongqing University Cancer Hospital'}}}}