Nimotuzumab Combined With Chemoradiotherapy Versus Chemoradiotherapy for Local Advanced Cervical Squamous Cell Carcinoma

NCT ID: NCT04678791

Last Updated: 2020-12-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 286 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-31
• Study Completion Date: 2025-12-31

Brief Summary

To investigate the efficacy and safety of nimotuzumab combined with concurrent chemoradiotherapy versus concurrent chemoradiotherapy in the treatment of local advanced cervical squamous cell carcinoma.

Detailed Description

This study adopts a multi-center, randomized controlled, open-label clinical trial design.

Conditions

Cervical Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nimotuzumab+ chemoradiotherapy

Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy.

Group Type: EXPERIMENTAL

Nimotuzumab

Intervention Type: DRUG

Patients receive Nimotuzumab 400 mg each time, once a week, slow intravenous drip, for a total of 6 weeks.

Cisplatin

Intervention Type: DRUG

Patients receive 40 mg/m2, d1, 7 days as 1 treatment cycle, 6 treatment cycles in total

External-beam radiation

Intervention Type: RADIATION

Patients undergo IMRT/VMAT radiotherapy with pelvic and/or extended field irradiation at a total dose of 45 - 50.4 Gy; 1.8 - 2.0 Gy/f, 25 - 28 f.

Brachytherapy

Intervention Type: RADIATION

Patient undergo Brachytherapy with high dose rate, with a total dose of 30-40 Gy and a cumulative dose of 80 \~ 85 Gy at point A/HRCTV D90; if the tumor diameter is ≥ 4 cm, the cumulative dose of ≥ 87 Gy at point A/HRCTV D90.

Chemoradiotherapy

Patients receive cisplatin and undergo external-beam radiation and brachytherapy

Group Type: ACTIVE_COMPARATOR

Cisplatin

Intervention Type: DRUG

Patients receive 40 mg/m2, d1, 7 days as 1 treatment cycle, 6 treatment cycles in total

External-beam radiation

Intervention Type: RADIATION

Patients undergo IMRT/VMAT radiotherapy with pelvic and/or extended field irradiation at a total dose of 45 - 50.4 Gy; 1.8 - 2.0 Gy/f, 25 - 28 f.

Brachytherapy

Intervention Type: RADIATION

Patient undergo Brachytherapy with high dose rate, with a total dose of 30-40 Gy and a cumulative dose of 80 \~ 85 Gy at point A/HRCTV D90; if the tumor diameter is ≥ 4 cm, the cumulative dose of ≥ 87 Gy at point A/HRCTV D90.

Interventions

Nimotuzumab

Patients receive Nimotuzumab 400 mg each time, once a week, slow intravenous drip, for a total of 6 weeks.

Intervention Type: DRUG

Cisplatin

Patients receive 40 mg/m2, d1, 7 days as 1 treatment cycle, 6 treatment cycles in total

Intervention Type: DRUG

External-beam radiation

Patients undergo IMRT/VMAT radiotherapy with pelvic and/or extended field irradiation at a total dose of 45 - 50.4 Gy; 1.8 - 2.0 Gy/f, 25 - 28 f.

Intervention Type: RADIATION

Brachytherapy

Patient undergo Brachytherapy with high dose rate, with a total dose of 30-40 Gy and a cumulative dose of 80 \~ 85 Gy at point A/HRCTV D90; if the tumor diameter is ≥ 4 cm, the cumulative dose of ≥ 87 Gy at point A/HRCTV D90.

Intervention Type: RADIATION

Other Intervention Names

EGFR monoclonal antibody; Cisplatin injection

Eligibility Criteria

Inclusion Criteria

1. Aged 18-75 years old;

2. Histologically diagnosed primary cervical squamous cell carcinoma, with clinical stage IB3-IVA (FIGO 2018);

3. At least one measurable lesion according to RECIST 1.1;

4. Absence of severe hematopoietic dysfunction and heart, lung, liver, kidney dysfunction and immunodeficiency, laboratory test results meet the following criteria:

Hemoglobin ≥ 90 g/L; Absolute neutrophil count ≥ 2 × 109/L or white blood cell count ≥ 4.0 × 109/L; Platelet count ≥ 100 × 109/L; Aspartate aminotransferase (AST) ≤ 2.5 × ULN Alanine aminotransferase (ALT) ≤ 2.5 × ULN Total bilirubin ≤ 1.5 × ULN; Serum creatinine ≤ 1.0 × ULN;

5. ECOG score 0-2 points;

6. Expected survival ≥ 3 months;

7. Women of childbearing potential must have a negative serum or urine HCG within 72 hours prior to enrollment (postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. A pregnancy test is not required for women who have demonstrated tubal ligation);

8. No intrauterine device;

9. Women of childbearing potential who are willing to take medically recognized contraceptive measures during the trial;

10. Compliance is good and informed consent is voluntarily signed.

Exclusion Criteria

1. Cervical adenocarcinoma and rare pathological types of malignant tumors;

2. Previous surgery for cervical cancer, pelvic radiation therapy, systemic chemotherapy, tumor targeted therapy, immunotherapy;

3. Ureteral obstruction, inability to place ureteral stent or pyelostomy;

4. Pregnant or lactating women;

5. Patients with rectovaginal fistula/vaginovesical fistula/uncontrolled vaginal bleeding or at risk of fistula;

6. Human immunodeficiency virus (HIV) infection;

7. Active hepatitis B (the quantitative detection result of HBV DNA exceeds the lower limit of detection), or HCV infection (the quantitative detection result of HCV RNA exceeds the lower limit of detection);

8. Patients have a serious underlying condition that precludes safe administration of trial treatment. Including but not limited to active infection requiring systemic drug therapy: decompensated heart failure (NYHA Class III and IV), unstable angina pectoris, acute myocardial infarction within 3 months prior to enrollment;

9. Patients with a history of other malignant tumors (except cured cutaneous basal cell carcinoma);

10. Patients with Crohn's disease and ulcerative colitis;

11. Patients who are participating in other clinical trials or have stopped clinical trials for less than 4 weeks;

12. Patients with known hypersensitivity to Nimotuzumab or its components;

13. Patients with contraindications to cisplatin;

14. Patients with neurological or psychiatric disorders affecting cognitive ability;

15. Patients whose lesions cannot be treated with intracavitary radiotherapy as assessed by the investigator;

16. Other reasons that, in the judgment of the investigator, would make the patient inappropriate for the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Junjie Wang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University 3rd Hospital

Beijing, Beijng, China

Countries

China

Other Identifiers

M2020411

Identifier Type: -

Identifier Source: org_study_id