Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-02-22 @ 10:36 PM
Study NCT ID:
NCT01917695
Status:
UNKNOWN
Last Update Posted:
2015-08-13
First Post:
2013-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Early Stage Bulky Cervical Cancers
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': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D001918', 'term': 'Brachytherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011878', 'term': 'Radiotherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-11', 'studyFirstSubmitDate': '2013-08-03', 'studyFirstSubmitQcDate': '2013-08-05', 'lastUpdatePostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of Life', 'timeFrame': '3,5 years'}], 'primaryOutcomes': [{'measure': 'Overall and Disease free Survival', 'timeFrame': '3 year'}, {'measure': 'Overall and Disease free Survival', 'timeFrame': '5 year'}], 'secondaryOutcomes': [{'measure': 'Acute Adverse reactions and complications', 'timeFrame': 'Less than 10 weeks'}, {'measure': 'SubAcute Adverse reactions and complications', 'timeFrame': '10 weeks - 6 months'}, {'measure': 'Chronic Adverse reactions and complications', 'timeFrame': '6 months to 5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bulky cervical cancers', 'Neoadjuvant Chemotherapy', 'Neoadjuvant Chemoradiotherapy'], 'conditions': ['Carcinoma Cervix']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to establish the role of neoadjuvant chemotherapy and chemo irradiation in carcinoma cervix and to compare its results with the concurrent chemo irradiation in terms of overall survival, disease free survival and quality of life.', 'detailedDescription': 'Early stage bulky cancers of the cervix, (defined as FIGO Stages IB2, IIA2 and IIB) form a distinctive subset of "curable" cervical cancers with good 5 year survival rates with adequate treatment. Concurrent chemo radiation with or without salvage surgery is at present the standard of care for this group of cervical cancers. However, when pelvic recurrences occur, the morbidity of salvage surgery after radiotherapy, especially brachytherapy is often higher than the morbidity of salvage radiotherapy following radical surgery. The advantages of downsizing the disease without the use of brachytherapy are tempting and open a completely new philosophy in radical treatment for "curable" early stage bulky cancers of the cervix. This approach is appealing especially in developing countries where the load of cervical cancers is high and radiotherapy (brachytherapy) resources are scarce.\n\nThe results of two Phase II trials conducted at Govt. Royapettah Hospital, Chennai (Neoadjuvant Chemotherapy followed by Radical Hysterectomy: Cisplatin + 5FU vs. Cisplatin +Paclitaxel) and at Govt. General Hospital,Chennai (Neoadjuvant Chemoradiation with weekly cisplatin and 50 EBRT followed by radical Hysterectomy) and one retrospective study ( Preoperative 50 GY EBRT followed by Radical Hysterectomy) have shown similar response rates and acceptable toxicity profiles when compared to concurrent chemoradiation (EBRT + Brachytherapy+ Chemotherapy). Similar studies have been published elsewhere with similar results.\n\nWith this in mind we are planning to conduct a Phase III Randomised control trial comparing Neoadjuvant Chemotherapy + Radical Hysterectomy and Neoadjuvant Chemoradiation + Radical Hysterectomy with concurrent chemoradiation in this subset of cervical cancers'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with histologically confirmed bulky cervical Squamous cell carcinoma (FIGO stage IB2, II A2, IIB).\n2. Age 18-60 years\n3. Karnofsky performance status of ≥70%; ECOG PS ≤ 2\n\nExclusion Criteria:\n\n1. Nonsquamous Histologies\n2. Other systemic diseases, comorbidities precluding full participation in the study\n3. Concomitant treatment with any experimental drug\n4. Pregnant or nursing women\n5. Previous or concomitant malignant diseases other than non-melanoma skin cancer\n6. Previous radiation to the pelvis'}, 'identificationModule': {'nctId': 'NCT01917695', 'briefTitle': 'Study on Early Stage Bulky Cervical Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Government Royapettah Hospital'}, 'officialTitle': 'Randomised Phase III Clinical Trial on Concurent Chemoradiation vs. Neoadjuvant Chemoradiation and Surgery vs. Neoadjuvant Chemotherapy and Surgery in Early Stage Bulky Cervical Cancers (FIGO Stages IB2, IIA2 and IIB)', 'orgStudyIdInfo': {'id': 'GRHCO-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Concurrent Radical Chemoradiation', 'description': 'Paclitaxel(175 mg/sq.m) + Cisplatin (75 mg/sq.m) chemotherapy - 2 cycles of 3 weekly cycle Concurrent Radiotherapy - 50 Gy EBRT + Brachytherapy (7Gy HDR x 3 doses) All to be completed within 8-10 weeks', 'interventionNames': ['Drug: Chemotherapy', 'Radiation: External Beam Radiotherapy', 'Radiation: Brachytherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Neoadjuvant Chemoradiation + Radical Hysterectomy', 'description': 'Paclitaxel(175 mg/m2) + Cisplatin(75 mg/m2) chemotherapy - 2 cycles of 3 weekly cycle Concurrent Radiotherapy - 50 Gy EBRT - completed within 5 weeks Radical Hysterectomy - 3 weeks after completion of RT All to be completed within 8-10 weeks', 'interventionNames': ['Drug: Chemotherapy', 'Radiation: External Beam Radiotherapy', 'Procedure: Radical Hysterectomy']}, {'type': 'EXPERIMENTAL', 'label': 'Neoadjuvant Chemotherapy + Radical Hysterectomy', 'description': 'Paclitaxel(175 mg/m2) + Cisplatin (75 mg/m2) chemotherapy - 3 cycles of 3 weekly cycle Radical Hysterectomy - 3 weeks after completion of chemotherapy All to be completed within 8-10 weeks', 'interventionNames': ['Drug: Chemotherapy', 'Procedure: Radical Hysterectomy']}], 'interventions': [{'name': 'Chemotherapy', 'type': 'DRUG', 'description': 'cisplatin 75 mg/m2 Paclitaxel 175 mg/m2', 'armGroupLabels': ['Concurrent Radical Chemoradiation', 'Neoadjuvant Chemoradiation + Radical Hysterectomy', 'Neoadjuvant Chemotherapy + Radical Hysterectomy']}, {'name': 'External Beam Radiotherapy', 'type': 'RADIATION', 'description': '50 Gy/2 Gy/25 # external beam RT to cervix. four field technique. given concurrently with chemotherapy weeks 1 - 5', 'armGroupLabels': ['Concurrent Radical Chemoradiation', 'Neoadjuvant Chemoradiation + Radical Hysterectomy']}, {'name': 'Brachytherapy', 'type': 'RADIATION', 'description': 'Ir - 192 HDR Brachytherapy - intracavitary. 7Gy x 3#. given after completion of chemoRT.', 'armGroupLabels': ['Concurrent Radical Chemoradiation']}, {'name': 'Radical Hysterectomy', 'type': 'PROCEDURE', 'description': 'Type III Radical Hysterectomy + Bilateral Pelvic Node Dissection', 'armGroupLabels': ['Neoadjuvant Chemoradiation + Radical Hysterectomy', 'Neoadjuvant Chemotherapy + Radical Hysterectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '600014IndiaNaduI6', 'city': 'Chennai', 'state': 'Tamil Nadu', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Rajaraman Ramamurthy, MS MCh', 'role': 'CONTACT', 'email': 'rajaanu1@rediffmail.com', 'phone': '+919444046168'}, {'name': 'Subbiah Shanmugam, MS MCh', 'role': 'CONTACT', 'email': 'subbiah_doctor@yahoo.co.uk', 'phone': '+919360206030'}, {'name': 'Rajaraman Ramamurthy, MS MCh', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Subbiah Shanmugam, MS MCh', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Government Royapettah Hospital', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}], 'centralContacts': [{'name': 'Rajaraman Ramamurthy, MS MCh', 'role': 'CONTACT', 'email': 'rajaanu1@rediffmail.com', 'phone': '+919444046168'}, {'name': 'Subbiah Shanmugam, Ms MCh', 'role': 'CONTACT', 'email': 'subbiah_doctor@yahoo.co.uk', 'phone': '+919360206030'}], 'overallOfficials': [{'name': 'Rajaraman Ramamurthy, MS MCh', 'role': 'STUDY_CHAIR', 'affiliation': 'centre for oncology, Government Royapettah Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rajkumar Kottayasamy Seenivasagam', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MCh Surgical Oncology trainee', 'investigatorFullName': 'Rajkumar Kottayasamy Seenivasagam', 'investigatorAffiliation': 'Government Royapettah Hospital'}}}}