Adjuvant Concurrent Chemoradiotherapy Versus Radiotherapy in Early-stage Cervical Cancer Patients With Selected Intermediate-risk Factors: a Randomized Controlled Phase III Trials (ACCEPT Trial)
Overview
- Phase
- Phase 3
- Intervention
- adjuvant concurrent chemoradiotherapy
- Conditions
- Cervical Cancer
- Sponsor
- Ruijin Hospital
- Enrollment
- 340
- Locations
- 1
- Primary Endpoint
- 5-year recurrence-free survival
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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 radical surgery.
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 recurrence-free survival in early stage cervical cancer with intermediate risks (Sedlis criteria). However, significant heterogeneity exists in Sedlis criteria, high risk of relapse and death occurred in patients with (1) lympho-vascular space invasion(LVSI+) and deep 1/3 stromal invasion;(2) LVSI(+) and middle 1/3 stromal invasion, and tumor size≥4cm when compared with other factors. In addition, multiple studies have confirmed that (3)non-squamous histology is an independent prognostic factor in early stage cervical cancer, who might be benefited from adjuvant concurrent chemoradiotherapy. As a result, The objective of the trial is 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. The primary endpoint of the study is the recurrence-free survival from the day of randomization.
Investigators
Eligibility 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
Arms & Interventions
experimental group
concurrent chemotherapy: cisplatin（DDP） weekly, 40mg/m2, begin with radiation Drug: cisplatin（DDP） weekly; pelvic radiotherapy: 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.
Intervention: adjuvant concurrent chemoradiotherapy
controlled group
pelvic radiotherapy alone: 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.
Intervention: radiotherapy
Outcomes
Primary Outcomes
5-year recurrence-free survival
Time Frame: 5 years
From date of surgery until the date of first documented local-regional progression or distant metastasis (determined by CT or MRI scan and/or biopsy) or death (from any cause) assessed up to five years.
Secondary Outcomes
- Acute toxicity(3 months)
- Quality of Life (QoL)(2 years)
- 5-year overall survival(5 years)