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

Recruiting now · Phase 3

Conditions studied: Cervical Cancer

In brief

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.

Key facts

Study ID: NCT05277688
Run by: Ruijin Hospital
People needed: 340
Starts: 2022-03-15
Expected to finish: 2027-12-30
Last updated by the study team: 2022-09-16

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

Ruijin Hospital, Shanghai jiaotong univestigy school of medicine — Shanghai, Shanghai Municipality, China (enrolling)
Ruijin Hospital, Shanghai jiaotong univestigy school of medicine — Shanghai, Shanghai Municipality, China

Full record on ClinicalTrials.gov

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