- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02705612
Phase II Clinical Trial of Concurrent Chemoradiotherapy Combined Nimotuzumab for Stage IIB-IVA Cervical Cancer
Efficacy and Safety of Radiotherapy Concurrently Combined With Cisplatin and Nimotuzumab for Patients With Locally Advanced Cervical Cancer
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
For locally advanced cervical cancer, radical radiation with concurrent chemotherapy remains the standard treatment recommended by NCCN. However, in more than 35% of cases, tumor persistence recurrence or metastasis would occur after chemoradiation. Nimotuzumab, belongs to anti-EGFR monoclonal antibodies, has proved to be useful in multiple solid tumors, such as NPC, colorectal cancer, etc.
In recent years, nimotuzumab was also applied in recurrence or metastasis cervical cancer. It was proved to be well tolerated and might have a role in the treatment of advanced cervical cancer. However, there is no publication about nimotuzumab used in locally advanced cervical cancer.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Shaanxi
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Xi'an, Shaanxi, Kina, 710032
- Rekruttering
- Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
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Ledende efterforsker:
- Mei Shi, MD
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Kontakt:
- Mei Shi, MD
- Telefonnummer: +86-029-84775425
- E-mail: mshifmmu@yahoo.com
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Underforsker:
- Li-Chun Wei, M.D.,Ph.D
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 18 Years to 70 Years,female
- Histological diagnosis of squamous cell carcinoma of cervix, FIGO stage IIB-IVA,with diameter 4-6 cm, without distant metastasis.
- no chance of surgery confirmed by more than two deputy chief doctors of gynecology.
- Moderate or high expression of EGFR
- The function of main organ is normal, including blood, heart, lung, liver, and kidney. Without history of hypertension, stroke. Blood pressure is normal before treatment.
- WBC≥3.5×10E9/L,ANC≥1.5×10E9/L;HB≥90g/L,PLT≥100×10E9/L
- ALT, AST and Cr below 1.5 times of normal level
- Willing to accept treatment
- Ability to comply with trial requirements KPS≥70
Exclusion Criteria:
- Evidence of distance metastasis
- Impossible to measure the diameter of tumor, or the tumor is too huge (diameter>6cm)
- Couldn't examine with pelvic MRI due to a variety of reasons
- Used to treat with radiotherapy chemotherapy or molecular target therapy and immune therapy
- Diagnosed with another malignant tumor in 5 years
- Used to be a volunteer of other clinical trial.
- Used to be allergic reaction with grade 3 or 4 degree to any experimental drugs
- Severe medical history of lung ,liver, kidney or heart.
- Active infection in any part of the whole body.
- Examination results showed radiotherapy contraindications
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: control group
Patients receive cisplatin IV over 60-90 minutes on days 1, 8, 15, 22, and 29.
Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks.
Patients then undergo high-dose rate intracavitary brachytherapy.
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Eksperimentel: experimental group
Patients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group.
Patients also receive nimotuzumab during the external radiotherapy.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Overall survival rate
Tidsramme: at 3 years
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Described with Kaplan-Meier curves and unadjusted logrank tests.
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at 3 years
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disease free survival rate
Tidsramme: at 3 years
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at 3 years
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non-distant metastasis survival rate
Tidsramme: at 3 years
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at 3 years
|
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survival period of non-progressive.
Tidsramme: at 3 years
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at 3 years
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Livskvalitet
Tidsramme: 3 år
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3 år
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Radiation protocol compliance
Tidsramme: 3 years
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3 years
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Rate of acute and long-term toxicities
Tidsramme: 3 years
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3 years
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- XJFL-2016-02-LACC-Nimotuzumab
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Kliniske forsøg med Livmoderhalskræft
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Xin Jiang, MDUkendt
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Gangnam Severance HospitalAfsluttetAnterior Cervical Discectomy and Fusion (ACDF) kirurgiKorea, Republikken
-
University of ArkansasAfsluttetAnterior Cervical Discectomy and Fusion (ACDF)Forenede Stater
-
Cleveland Clinic Akron GeneralRekrutteringSmerte | Overfladisk Cervical Plexus BlockForenede Stater
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AxioMed Spine CorporationUkendtSymptomatisk Cervical Degenerative Disc Disease (DDD) Fra C3-C7Tyskland, Schweiz
-
Qilu Pharmaceutical Co., Ltd.RekrutteringMETASTATISK CERVICAL CANCERKina
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Orthofix Inc.AfsluttetDegenerativ diskussygdom | Vertebralt Cervical Fusion SyndromeForenede Stater
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Istanbul Medeniyet UniversityAktiv, ikke rekrutterendeDiafragmatisk lammelse | Frenisk nervelammelse | Anterior suprascapular nerveblok | Overfladisk Cervical Plexus BlockKalkun
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Antiva BiosciencesAfsluttetLivmoderhalskræft | Human Papilloma Virus | HSIL, højgradige pladeepitellæsioner | Cervikal dysplasi | HSIL af Cervix | Højgradig cervikal intraepitelial neoplasi | HIV negativ | CIN - Cervical Intraepithelial Neoplasia | Cervikal neoplasmaSydafrika
Kliniske forsøg med Cisplatin
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West China Second University HospitalRekrutteringNeoadjuverende kemoterapi | Epitelkarcinom, ovarieKina
-
Cedars-Sinai Medical CenterRekrutteringHPV-positivt orofaryngealt planocellulært karcinomForenede Stater
-
Privo TechnologiesNational Cancer Institute (NCI)AfsluttetOralt planocellulært karcinomForenede Stater
-
Lawson Health Research InstituteRekrutteringLokalt avanceret hoved- og halspladecellekarcinomCanada
-
Insmed IncorporatedAfsluttetOsteosarkom MetastatiskForenede Stater
-
Sun Yat-sen UniversityAktiv, ikke rekrutterendeNasopharyngealt karcinomKina
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Sun Yat-sen UniversityFirst Affiliated Hospital, Sun Yat-Sen University; Guangdong Provincial... og andre samarbejdspartnereAktiv, ikke rekrutterendeNasopharyngealt karcinom | Nasopharyngeale neoplasmer | Nasopharyngeale sygdomme | Neoplasma i hoved og halsKina
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Taiho Oncology, Inc.Quintiles, Inc.AfsluttetMavekræftForenede Stater, Canada
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Fujian Cancer HospitalIkke rekrutterer endnuNasopharyngealt karcinomKina
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Bangabandhu Sheikh Mujib Medical University, Dhaka...Afsluttet