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Study of Nimotuzumab Combined With IMRT in Elder Patients With Cervical Squamous Cell Carcinoma

21. juli 2021 oppdatert av: Junjie Wang, Peking University Third Hospital

A Perspective, Multi-center, Single Arm Study of Nimotuzumab Combined With IMRT in Elder Patients With Cervical Squamous Cell Carcinoma

To evaluate the efficacy and safety of Nimotuzumab combined with IMRT in elder patients with locally advanced cervical squamous cell carcinoma

Studieoversikt

Status

Har ikke rekruttert ennå

Detaljert beskrivelse

This is a perspective, multi-center, open-label and single arm study.

Studietype

Observasjonsmessig

Registrering (Forventet)

125

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Beijing
      • Beijing, Beijing, Kina, 100191
        • Peking University 3rd hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

65 år og eldre (Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

The elder patients with cervical squamous cell cancer received nimotuzumab combined with radiotherapy.

Beskrivelse

Inclusion Criteria:

  1. Age≥65 years old
  2. Histologically confirmed primary cervical squamous cell carcinoma in stage IB3-IVA (FIGO 2018)
  3. At least one measurable lesion according to RECIST 1.1 guideline
  4. Patients are intolerant to or refuse chemotherapy.
  5. No serious hematopoietic dysfunction, nor abnormal heart, lung, liver and kidney function, nor immunity deficiency. And the results of lab test meet the following criteria:

    Hemoglobin ≥90g/L Absolute count of neutrophils≥2×109/L orwhite blood cell count≥4.0×109/L; Platelet count≥100×109/L; AST≤2.5×ULN ALT≤2.5×ULN TBIL≤1.5×ULN;

    Serum creatinine≤1.5×ULN or CrCl> 60 mL/min(according toCockcroft-Gault):

    Serum creatinine≤1.5×ULN Female CrCl=(140-Age)×Weight(kg)×0.85 / (72×Scr mg/dl)

  6. ECOG score 0-2
  7. Expectancy of life is at least 3 months.
  8. Eligible for pelvic MRI examination.
  9. The patients voluntarily received nimotuzumab combined with radiotherapy.
  10. Patients can comply with the protocol and are willing to sign informed consent.

Exclusion Criteria:

  1. Patients who have received treatment for cervical cancer, including surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy
  2. Patients who have bilateral ureteral obstruction, who cannot be placed ureteral stents or perform pyelostomy.
  3. Patients with rectovaginal fistula/vaginovesical fistula/uncontrolled vaginal bleeding or with fistula risk.

.4)Patients infected with HIV. 5)Active hepatitis B (HBV DNA quantitative test results exceed the detection threshold), or HCV infection (HCV RNA quantitative test results exceed the detection threshold) 6)Patients with severe underlying disease that makes it possible to safely receive the treatment. And the severe underlying disease include but not limited to active infections requiring systemic medication, decompensated heart failure (NYHA grade III and IV), unstable angina pectoris, and acute myocardial infarction occurred within the first 3 months of enrollment.

7)Patients with a history of prior malignancy other than cured basal cell carcinoma of the skin.

8)Patients with Crohn's disease and ulcerative colitis. 9)Patients are allergic to Nimotuzumab or its compounds. 10)Patients with neurological or psychiatric abnormalities that affect cognitive ability.

11)Intracavitary brachytherapy cannot be performed that was assessed by the investigator.

12)Other factors were assessed by investigators to be unsuitable to this study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
observation group
All patients will be treated with Nimotuzumab combined with radiotherapy.
Patients receive Nimotuzumab: 200mg, intravenous infusion, weekly for 6 weeks.

IMRT/VMAT are adopted. A total dose of 45-50.4 Gy, 1.8~2.0Gy/f, 25~ 28F in pelvic and/or extension filed. For patients with metastasis in pelvic lymph node and abdominal para-aortic lymph node, the dose of radiation in local lesion will be increased to 60~66Gy. For patients at stage IIIB, concurrent radiation will be given in parametrial extension or in the late course the dose will be increased to 60Gy.

Brachytherapy: Three dimensional high dose rate brachytherapy is used with HR-CTV D90 cumulative dose of 80~85Gy (EQD2); If the tumor diameter is ≥4cm, HR-CTV D90 cumulative dose is ≥87Gy (EQD2). Brachytherapy combined with external beam radiotherapy will be completed within 8 weeks.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
3-year disease-free survival(DFS)
Tidsramme: up to 3 years
The rate of patient without disease in 3 years after treatment
up to 3 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Complete response rate(CRR)
Tidsramme: 3 months later after treatment
The percentage of subjects who achieve complete response by imaging assessment from the end of the treatment to disease progression
3 months later after treatment
Objective response rate(ORR)
Tidsramme: 3 months later treatment
The percentage of patients who experienced complete or partial cancer shrinkage or disappearance after treatment
3 months later treatment
3-year overall survival(OS)
Tidsramme: up to 3 years
The rate of patient alive in 3 years after treatment
up to 3 years
The change of tumor related markers
Tidsramme: up to 3 years
the correlation of the value of SCC,Cyfra 21-1 and therapeutic effect [The changes of serum tumor markers (such as SCC-Ag and CYFRA21-1) were observed before and after treatment]
up to 3 years
The change of cervical tumor
Tidsramme: At diagnosis and before brachytherapy
the change of the volume of the cervical tumor at diagnosis and before brachytherapy
At diagnosis and before brachytherapy
QUALITY OF LIFE(QoL)
Tidsramme: up to 3 years
Quality of life assessed by EORTC QLQ-CX 24 [EORTC QLQ-CX 24 is a specific quality of life assessment scale based on EORTC QLQ-C 30, with 24 items]
up to 3 years
SAFETY
Tidsramme: up to 3 years
Including severity of adverse events, the incidence of adverse events and serious adverse events. Adverse events should be reported and graded according to CTCAE version 5.0
up to 3 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. juli 2021

Primær fullføring (Forventet)

1. desember 2025

Studiet fullført (Forventet)

1. desember 2026

Datoer for studieregistrering

Først innsendt

2. juli 2021

Først innsendt som oppfylte QC-kriteriene

21. juli 2021

Først lagt ut (Faktiske)

26. juli 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. juli 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. juli 2021

Sist bekreftet

1. juli 2021

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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