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A Prospective Randomized Controlled Trial of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation Versus Concurrent Chemoradiation Therapy Alone in Advanced Cervical Cancer

A Prospective Randomized Controlled Trial of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation Versus Concurrent Chemoradiation Therapy Alone in Advanced Cervical Cancer

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054929
Enrollment
Unknown
Registered
2021-12-29
Start date
2022-03-01
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical cancer

Interventions

Intervention group:NACT+CCRT

Sponsors

Sichuan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years; 2. Patients must have histologically confirmed cervical cancer with adenocarcinoma, adenosquamous or squamous histology and FIGO 2018 Ib3-IIIb; 3. According to the RECIST 1.1 standard, the subject must have at least one measurable target lesion; 4. No prior treatment; 5. Expected survival period >= 3 months; 6. ECOG score: 0-1; 7. No obvious signs of hematological diseases, ANC >= 1.5 x 10^9/L, platelet count >= 100 x 10^9/L, Hb >= 90 g/L, WBC >= 3.0 x 10^9/L, and no bleeding tendency before enrollment; 8. Adequate hepato-renal function is needed, including: total bilirubin (TBIL)= 50 mL/min; 9. Patients voluntarily participated in the study and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding female patients (women of child-bearing potential must confirm that the pregnancy test is negative within 7 days before the first administration. If it is positive, ultrasound examination must be performed to exclude pregnancy), or women of child-bearing potential who refused to receive contraceptive measures; 2. Combined with other malignant tumors, except for cured skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of any other part; 3. Existence of any bone marrow dysplasia and other abnormal hematopoietic diseases; 4. Active infections, HIV infections, and viral hepatitis that require systematic treatment; 5. Patients with >= grade 1 peripheral neuropathy according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 5.0; 6. Had severe cardiovascular diseases such as cerebrovascular accident, myocardial infarction, hypertension that cannot be controlled after drug intervention, unstable angina pectoris, heart failure (NYHA 2-4) and arrhythmia that need drug intervention within 6 months; 7. It is known to have a history of allergies to research drugs or drug components; 8. Has participated in other anti-tumor intervention clinical trials within 30 days before the first medication; 9. Have a clear history of dementia, mental state changes or any mental illness that will hinder understanding or informed consent; 10. The investigator believes that the patient is not suitable for participating in this clinical research.

Design outcomes

Primary

MeasureTime frame
Progression free survival (PFS);

Secondary

MeasureTime frame
Objective Response Rate (ORR);Overall Survival (OS);Number of participants who experience one or more adverse events (AEs);

Countries

China

Contacts

Public ContactZhang Guonan

Sichuan Cancer Hospital

zhanggn@hotmail.com+86 13881866599

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026