- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT04976478
Study of Nimotuzumab Combined With IMRT in Elder Patients With Cervical Squamous Cell Carcinoma
A Perspective, Multi-center, Single Arm Study of Nimotuzumab Combined With IMRT in Elder Patients With Cervical Squamous Cell Carcinoma
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studiecontact
- Naam: Junjie Wang, MD
- Telefoonnummer: 5920 010-82266699
- E-mail: junjiewang_edu@sina.com
Studie Locaties
-
-
Beijing
-
Beijing, Beijing, China, 100191
- Peking University 3rd hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Age≥65 years old
- Histologically confirmed primary cervical squamous cell carcinoma in stage IB3-IVA (FIGO 2018)
- At least one measurable lesion according to RECIST 1.1 guideline
- Patients are intolerant to or refuse chemotherapy.
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)
- ECOG score 0-2
- Expectancy of life is at least 3 months.
- Eligible for pelvic MRI examination.
- The patients voluntarily received nimotuzumab combined with radiotherapy.
- Patients can comply with the protocol and are willing to sign informed consent.
Exclusion Criteria:
- Patients who have received treatment for cervical cancer, including surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy
- Patients who have bilateral ureteral obstruction, who cannot be placed ureteral stents or perform pyelostomy.
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
3-year disease-free survival(DFS)
Tijdsspanne: up to 3 years
|
The rate of patient without disease in 3 years after treatment
|
up to 3 years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Complete response rate(CRR)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: up to 3 years
|
The rate of patient alive in 3 years after treatment
|
up to 3 years
|
|
The change of tumor related markers
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Verwacht)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ChiECRCT20210238
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .