Adjuvant Concurrent Chemoradiotherapy Versus Radiotherapy in Early-stage Cervical Cancer Patients
Adjuvant Concurrent Chemoradiotherapy Versus Radiotherapy in Early-stage Cervical Cancer Patients With Selected Intermediate-risk Factors: a Randomized Controlled Phase III Trials (ACCEPT Trial)
Ruijin Hospital
340 participants
Mar 15, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- • 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 Criteria9
- • 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
Interventions
concurrent chemotherapy: cisplatin（DDP） weekly, 40mg/m2, begin with radiation Drug: cisplatin（DDP） weekly; Intensity modulated radiotherapy (IMRT) is given five fractions per week at 1.8-2 Gy/fraction/day with total dose summed up to 45-50Gy.
Intensity modulated radiotherapy (IMRT) is given five fractions per week at 1.8-2 Gy/fraction/day with total dose summed up to 45-50Gy.
Locations(2)
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NCT05277688