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Prospective randomized trial comparing pelvic radiotherapy with or without brachytherapy boost in post-operative patients with cervical carcinoma

Prospective randomized trial comparing pelvic radiotherapy with or without brachytherapy boost in post-operative patients with cervical carcinoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032073
Enrollment
Unknown
Registered
2020-04-19
Start date
2020-04-20
Completion date
Unknown
Last updated
2020-04-27

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

Conditions

cervical cancer

Interventions

with brachytherapy boost group:with brachytherapy boost
without brachytherapy boost group:without brachytherapy boost group

Sponsors

Sun-Yat Sen Memorial Hospital, Sun-Yat Sen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with squamous-cell carcinoma or adenocarcinoma (according to WHO histological type) confirmed by operation; 2. Aged 18-70 years; 3. Tumor staged as I/IIA (according to the FIGO 2009 edition staging system); 4. Received a radical hysterectomy and lymphadenectomy; 5. No evidence of distant metastasis (M0); 6. Performance status: KPS > 70; 7. Adequate marrow, normal renal and liver function tese; 8. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. WHO type non-squamous cell carcinoma or non-adenocarcinoma such as neurosecretory large/small cell carcinoma, and the sarcoma; 2. Patients with radical chemoradiotherapy; 3. Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin); 4. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period); 5. 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 x ULN), and emotional disturbance; 7. Previous hysterectomy with benign uterine lesions do not affect the enrollment.

Design outcomes

Primary

MeasureTime frame
5-year local-regional recurrences free survival rate;

Secondary

MeasureTime frame
5-year overall survival;5-year disease-free survival;

Countries

China

Contacts

Public ContactShoumin 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