Adjuvant Concurrent Chemoradiotherapy Versus Radiotherapy in Early-stage Cervical Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: adjuvant concurrent chemoradiotherapy, radiotherapy.
- Who it may be relevant to
- Registry conditions: Cervical Cancer. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
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.
Interventions
- Drug adjuvant concurrent chemoradiotherapy
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. - Radiation 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.
Primary outcome measures
- 5-year recurrence-free survival [Time frame: 5 years]
Secondary outcome measures (3)
- 5-year overall survival [Time frame: 5 years]
- Acute toxicity [Time frame: 3 months]
- Quality of Life (QoL) [Time frame: 2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Ruijin Hospital, Shanghai jiaotong univestigy school of medicine — Shanghai
- Ruijin Hospital, Shanghai jiaotong univestigy school of medicine — Shanghai
Identifiers
NCT: NCT05277688 · 2021(237)