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Chemotherapy in Post-Surgery in the treatment of Cervical Cancer, a multicenter, randomized controlled trial

A Multicenter Trial of Benefits of Adding Chemotherapy as the Adjuvant Post-Surgery Therapy for Cervical Cancer With Adverse Pathological Prognostic Factors

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-08000197
Enrollment
Unknown
Registered
2008-11-20
Start date
2008-01-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Ib~IIa Cervical Cancer

Interventions

Radiotherapy:External irradiation 50Gy/5 weeks Lateral: 2 cm lateral to the bony margin of the pelvis Superior: Between L5 and S1 Inferior: 2 cm below the obturator foramen Intracavitary boost 30-35Gy
Concurrent chemoradiation:External beam radiation with concurrent weekly platinum chemotherapy
Sequence chemotherapy and radiotherapy:2 cycles chemotherapy of Paclitaxel and Cisplatin before and after the irradiation

Sponsors

Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with newly histologically confirmed cervical carcinoma Original clinical stage must be Ib~IIa (FIGO) Age between 18-65 With the presence of these four factors after radical surgery: (1) positive lymph nodes; (2) positive parametria, or positive surgical margins; (3) positive lymphatic vascular space; (4) outer one-third invasion of the cervical stroma. More than 3 months survival is to expect Patients must give signed informed consent.

Exclusion criteria

Exclusion criteria: The presence of uncontrolled life-threatening illness; Receiving other ways of anti-cancer therapy; Residual tumor which can not be removed in the surgery; Investigator consider the patients can't finish the whole study; With normal liver function test (ALT, AST>2.5*ULN); With normal renal function test (Creatinine>1.5*ULN); WBC<4,000/mm3 or PLT<100,000/mm3; Receive the external pelvic irradiation before the surgery.

Design outcomes

Primary

MeasureTime frame
overall survival, 5-year survival;

Secondary

MeasureTime frame
distant metastasis free survival,disease free survival;

Countries

China

Contacts

Public ContactJihong Liu
Lijih@mail.sysu.edu.cn+86 0 13826299236

Outcome results

None listed

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