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Prospective randomized trial comparing three fractions of brachytherapy before external beam irradiation and the conventional external beam irradiation followed by brachytherapy in patients with locally advanced cervical carcinoma

Prospective randomized trial comparing three fractions of brachytherapy before external beam irradiation and the conventional external beam irradiation followed by brachytherapy in patients with locally advanced cervical carcinoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17012823
Enrollment
Unknown
Registered
2017-09-27
Start date
2017-09-19
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

Experimental group:three fractions of brachytherapy before external beam irradiation
Control:Regular radiotherapy

Sponsors

Sun Yat-sen memorial hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
19 Years to 69 Years

Inclusion criteria

Inclusion criteria: 1. Patients with newly histologically confirmed squamous-cell carcinoma (according to WHO histological type); 2. Aged 18-70 years; 3. Tumor staged as II/III (according to the FIGO 2009 edition staging system); 4. No evidence of distant metastasis (M0); 5. Performance status KPS > 70; 6. Adequate marrow, normal renal and liver function tese; 7. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. WHO type non-squamous cell carcinoma such as adenocarcinoma, neurosecretory large/small cell carcinoma, and the sarcoma; 2. Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin); 3. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period); 4. History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume); 6. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.

Design outcomes

Primary

MeasureTime frame
Tumor complete remission rate;

Secondary

MeasureTime frame
Overall survival;locoregional failure-free survival;

Contacts

Public ContactShou-min Bai

Sun Yat-sen memorial hospital, Sun Yat-sen University

baishm@mail.sysu.edu.cn+86 13802507186

Outcome results

None listed

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