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prospective phase III clinical trial to compare different treatment (IMRT+TPregimen, IMRT+weekly cisplatin and 3DCRT+weekly cisplatin) in treating late stage cervical cancer with concurrent chemoradiotherapy

prospective phase III clinical trial to compare different treatment (IMRT+TPregimen, IMRT+weekly cisplatin and 3DCRT+weekly cisplatin) in treating late stage cervical cancer with concurrent chemoradiotherapy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-17012830
Enrollment
Unknown
Registered
2017-09-29
Start date
2016-01-01
Completion date
Unknown
Last updated
2017-10-02

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

Conditions

Cervical Cancer

Interventions

3D-CRT+DDP:using 3D-CRT technique
IMRT+DDP:using IMRT technique
IMRT+TP:using TP chemotherapy regimen

Sponsors

Tumor Hospital of Shantou University Medical College
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with cervical cancer confirmed by histology or cytology; 2. Patients with International Federation of Gynecology and Obstetrics (FIGO 2009) stage III staged by at least one gynecological oncologist (associate chief physician or higher), and they were confirmed by image test such as CT or MRI; 3. Patients who had no prior anti-cancer treatment; 4. Patients who have at least one measurable lesion (at least 10mm*10mm in MRI scan of pelvis); 5. Aged 18 to 70 years; 6. ECOG performance status 0 - 2; 7. Weight >=40KG; 8. WBC >=4.0*10^9/L, Hemoglobin>=90g/L, Platelets >=100.0*10^9/L; Bilirubin <=ULN; ALT and AST and ALP<=2.5*ULN; BUN <=1.5*ULN; Creatinine<=1.5*ULN; 9. Signed study-specific informed consent.

Exclusion criteria

Exclusion criteria: 1. Any previous chemotherapy, radiotherapy or surgery for this tumour; 2. Para-aortic nodal involvement or evidence of distant metastasis; 3. Patients who have severe uncontrolled internal diseases or acute infection; 4. Patients who are pregnant or lactating; 5. Patients who did not sign study-specific informed consent; 6. Patients with other invasive malignancies within the last 5 years.

Design outcomes

Primary

MeasureTime frame
Acute hematological toxicity;

Secondary

MeasureTime frame
Acute gastrointestinal toxicity;Other chronic treatment-related toxicity rate;1-year local control rate;

Countries

China

Contacts

Public ContactXIE LIANGXI

Tumor Hospital of Shantou University Medical College

xieliangxi1@qq.com+86 13556399049

Outcome results

None listed

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