Status:
RECRUITING
Adjuvant Concurrent Chemoradiotherapy Versus Radiotherapy in Early-stage Cervical Cancer Patients
Lead Sponsor:
Ruijin Hospital
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18-80 years
Phase:
PHASE3
Brief Summary
To evaluate if adjuvant concurrent chemoradiotherapy is associated with a recurrence-free survival benefit in comparison with radiotherapy alone in selected intermediate risk cervical cancer after rad...
Detailed Description
Adjuvant therapy for patients with cervical cancer (CC) with intermediate-risk factors remains controversial. According to result of GOG 92 trail, adjuvant radiotherapy significantly improved recurren...
Eligibility Criteria
Inclusion
- • 18 Years to 80 Years
- Histologically proven cervical cancer, FIGO stage Ia2-IIb,and no previous chemotherapy and radiotherapy
- Accepted radical hysterectomy 3-4 weeks before
- Karnofsky score \>70
- Postoperative pathology with one of the three risk factors criterials: (1) lympho-vascular space invasion(LVSI+) and deep 1/3 stromal invasion; (2 ) LVSI(+) and middle 1/3 stromal invasion, and tumor size≥4cm (3)Non-squamous cell carcinoma;
- Examination results showed no radiation or chemotherapy contraindication
- Willing to accept treatment
- Ability to comply with trial requirements
Exclusion
- • Postoperative residual
- Postoperative recurrence or metastasis
- Pelvic lymph node metastasis
- parametrial invasion
- positive surgical margin
- Without lymph node dissection
- Postoperative pathology showed aortic lymph node metastasis
- Examination results showed radiotherapy contraindications
- No indications for radiotherapy
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT05277688
Start Date
March 15 2022
End Date
December 30 2027
Last Update
September 16 2022
Active Locations (2)
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1
Ruijin Hospital, Shanghai jiaotong univestigy school of medicine
Shanghai, Shanghai Municipality, China, 200025
2
Ruijin Hospital, Shanghai jiaotong univestigy school of medicine
Shanghai, Shanghai Municipality, China, 200025