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A randomized controlled study of concurrent chemoradiotherapy with or without consolidation chemotherapy for cervical cancer patients with lymph node metastasis after radical operation

A randomized controlled study of concurrent chemoradiotherapy with or without consolidation chemotherapy for cervical cancer patients with lymph node metastasis after radical operation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032834
Enrollment
Unknown
Registered
2020-05-12
Start date
2020-08-16
Completion date
Unknown
Last updated
2020-08-17

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

Conditions

Cervical Cancer

Interventions

experimental group:concurrent chemoradiotherapy combined with consolidation chemotherapy

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 - 70, ECOG performance status 0 - 2; 2. Clinical stage IA2, IB, or IIA, receive extensive abdominal hysterectomy with pelvic lymphadenectomy with or without para-aortic lymphadenectomy/biopsy; 3. The postoperative pathology is cervical squamous cell carcinoma, cervical adenosquamous cell carcinoma or cervical adenocarcinoma; 4. Lymph node metastasis confirmed by postoperative pathology; 5. No previous radiotherapy / chemotherapy; 6. No severe hematopoiesis, heart, lung, liver and kidney dysfunction and immune deficiency: bilirubin = 1.5 × ULN, AST or ALT = 2.5 × ULN, creatinine = 1.5 times the upper limit of normal value, HB = 10.0 g / dl, WBC = 3.5 × 109 / L, ANC = 2.0 × 109 / L, platelet = 100 × 109 / L; 7. Written informed consent; 8. Cooperate with follow-up; 9. Expected lifetime = 6 months.

Exclusion criteria

Exclusion criteria: 1. Positive parametrial and vaginal incisions confirmed by postoperative pathology; 2. Suffering from other malignant tumors; 3. Known allergy to cisplatin / carboplatin and paclitaxel; 4. Clinically serious (i.e. active) heart disease, such as symptomatic coronary heart disease, NYHA class II or more congestive heart failure or serious arrhythmia requiring drug intervention, or a history of myocardial infarction within the last 12 months; 5. Organ transplant patients in need of immunosuppressive therapy; 6. Severe uncontrolled repeated infection, or other serious complications; 7. Distant metastasis detected by CT, MRI and/or PET-CT; 8. Participated in other clinical trials; 9. Drug addiction, chronic alcoholism or AIDS.

Design outcomes

Primary

MeasureTime frame
OS;PFS;

Secondary

MeasureTime frame
Toxic reaction;Quality of life;

Countries

China

Contacts

Public ContactWu Xiaohua

Fudan University Shanghai Cancer Center

docwuxh@yahoo.com+86 021 64175590

Outcome results

None listed

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