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A phase III randomized controlled clinical study for chemoradiotherapy combined with or without external irradiation boost in local tumor beds after radical resection of early cervical cancer with whole-layer and above infiltration

A phase III randomized controlled clinical study for chemoradiotherapy combined with or without external irradiation boost in local tumor beds after radical resection of early cervical cancer with whole-layer and above infiltration

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027272
Enrollment
Unknown
Registered
2019-11-07
Start date
2019-10-24
Completion date
Unknown
Last updated
2019-11-11

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:standard chemoradiotherapy± boost in local tumor bed

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Cervical cancer patients with whole layer or above myometrial infiltration after early cervical cancer radical resection.; 2. Aged 18 to 65 years; 3. ECOG performance status 0 - 2; 4. Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervixWBC >=3.0 x 10^9/L and ANC >=2.0 x 10^9/L; Platelets >=100 x 10^9/L; Bilirubin =60ml/min or >=50 ml/min by EDTA creatinine clearance; 6. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. postoperative positive parametrial and/or surgical margins; 2. Previous radiotherapy and/or chemotherapy for this tumor; 3. Patients with bilateral hydronephrosis unless at least one side has been stented and renal function fulfils the required inclusion criteria; 4. Evidence of distant metastases; 5. Prior diagnosis of Crohns disease or ulcerative colitis; 6. Patients with other invasive malignancies; 7. Patients who are pregnant or lactating; 8. Any contraindication to the use of cisplatin chemotherapy; 9. Serious illness or medical condition that precludes the safe administration of the trial treatment including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; 10. HIV positive.

Design outcomes

Primary

MeasureTime frame
RFS;

Secondary

MeasureTime frame
OS;adverse effect;

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