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

NCT04976478 | Not Yet Recruiting

• 1 other identifier: ChiECRCT20210238
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cervical Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 3-year disease-free survival(DFS)

  The rate of patient without disease in 3 years after treatment

  up to 3 years

Secondary Outcomes (7)

• Complete response rate(CRR)

  3 months later after treatment

• Objective response rate(ORR)

  3 months later treatment

• 3-year overall survival(OS)

  up to 3 years

• The change of tumor related markers

  up to 3 years

• The change of cervical tumor

  At diagnosis and before brachytherapy

Study Arms (1)

observation group

All patients will be treated with Nimotuzumab combined with radiotherapy.

Drug: Nimotuzumab; Radiation: EBRT combined with brachytherapy

Interventions

Nimotuzumab DRUG

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

observation group

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.

observation group

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• )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.
• )Patients with a history of prior malignancy other than cured basal cell carcinoma of the skin.
• )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.
• )Intracavitary brachytherapy cannot be performed that was assessed by the investigator.
• )Other factors were assessed by investigators to be unsuitable to this study.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University 3rd Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Interventions

nimotuzumab; Brachytherapy

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Central Study Contacts

Junjie Wang, MD

CONTACT

010-82266699; junjiewang_edu@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department director

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 26, 2021
• Study Start: July 1, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 26, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)