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

ConditionCervical Squamous Cell Carcinoma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age65+
SponsorPeking University Third Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Nimotuzumab

    Drug

    Patients receive Nimotuzumab: 200mg, intravenous infusion, weekly for 6 weeks.

  • EBRT combined with brachytherapy

    Radiation

    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.

Treatment groups

125 Participants
are divided into 1 treatment group
Group A: observation group2 interventions

Trial outcomes

Primary outcomes

1

3-year disease-free survival(DFS)

The rate of patient without disease in 3 years after treatment

Time frame
up to 3 years

Secondary outcomes

1

Complete response rate(CRR)

The percentage of subjects who achieve complete response by imaging assessment from the end of the treatment to disease progression

Time frame
3 months later after treatment
2

Objective response rate(ORR)

The percentage of patients who experienced complete or partial cancer shrinkage or disappearance after treatment

Time frame
3 months later treatment
3

3-year overall survival(OS)

The rate of patient alive in 3 years after treatment

Time frame
up to 3 years
4

The change of tumor related markers

the correlation of the value of SCC，Cyfra 21-1 and therapeutic effect \[The changes of serum tumor markers (such as SCC-Ag and CYFRA21-1) were observed before and after treatment\]

Time frame
up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University Third Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: