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

Shanghai Jiao Tong University

Status and phase: Enrolling; Phase 3

Conditions: Cervical Cancer

Treatments: Radiation: radiotherapy; Drug: adjuvant concurrent chemoradiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05277688

2021(237)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 340 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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340 participants in 2 patient groups

experimental group

Experimental group

Description:

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.

Treatment:

Drug: adjuvant concurrent chemoradiotherapy

controlled group

Active Comparator group

Description:

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.

Treatment:

Radiation: radiotherapy