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Phase II Clinical Trial of Concurrent Chemoradiotherapy Combined Nimotuzumab for Stage IIB-IVA Cervical Cancer

9. marts 2016 opdateret af: Mei Shi, Air Force Military Medical University, China

Efficacy and Safety of Radiotherapy Concurrently Combined With Cisplatin and Nimotuzumab for Patients With Locally Advanced Cervical Cancer

The purpose of this phase II trial is to determine the feasibility and efficacy of nimotuzumab injection combined with concurrent chemoradiotherapy for initially inoperable locally advanced cervical cancer.

Studieoversigt

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

Interventionel

Tilmelding (Forventet)

60

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Shaanxi
      • Xi'an, Shaanxi, Kina, 710032
        • Rekruttering
        • Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
        • Ledende efterforsker:
          • Mei Shi, MD
        • Kontakt:
        • Underforsker:
          • Li-Chun Wei, M.D.,Ph.D

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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.
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall survival rate
Tidsramme: at 3 years
Described with Kaplan-Meier curves and unadjusted logrank tests.
at 3 years
disease free survival rate
Tidsramme: at 3 years
at 3 years
non-distant metastasis survival rate
Tidsramme: at 3 years
at 3 years
survival period of non-progressive.
Tidsramme: at 3 years
at 3 years

Sekundære resultatmål

Resultatmål
Tidsramme
Livskvalitet
Tidsramme: 3 år
3 år
Radiation protocol compliance
Tidsramme: 3 years
3 years
Rate of acute and long-term toxicities
Tidsramme: 3 years
3 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2015

Primær færdiggørelse (Forventet)

1. september 2016

Studieafslutning (Forventet)

1. september 2018

Datoer for studieregistrering

Først indsendt

5. marts 2016

Først indsendt, der opfyldte QC-kriterier

9. marts 2016

Først opslået (Skøn)

10. marts 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. marts 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. marts 2016

Sidst verificeret

1. marts 2016

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Livmoderhalskræft

Kliniske forsøg med Cisplatin

3
Abonner