Overview

Adjuvant Concurrent Chemoradiotherapy Versus Radiotherapy in Early-stage Cervical Cancer Patients

Status:
Not yet recruiting
Trial end date:
2027-12-30
Target enrollment:
0
Participant gender:
Female
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 radical surgery.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ruijin Hospital
Criteria
Inclusion Criteria:

- • 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 Criteria:

- • 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