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

NCT ID: NCT05277688

Last Updated: 2022-09-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 340 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2027-12-30

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.

Conditions

Cervical Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

adjuvant concurrent chemoradiotherapy

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

radiotherapy

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: DRUG

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 Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ruijin Hospital, Shanghai jiaotong univestigy school of medicine

Shanghai, Shanghai Municipality, China

Site Status: NOT_YET_RECRUITING

Ruijin Hospital, Shanghai jiaotong univestigy school of medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wei-Xiang Qi, Dr.

Role: CONTACT

qiweixiang1113@163.com

+862164370045

Facility Contacts

Yifeng Wang

Role: primary

+862164370045

Yifeng Wang

Role: primary

+862164370045

Other Identifiers

2021(237)

Identifier Type: -

Identifier Source: org_study_id