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Intermediate Risk Cervical Cancer: Radical Surgery +/- Adjuvant Radiotherapy

NCT04989647RecruitingPHASE3INTERVENTIONAL

Summary

The objective of the trial is to evaluate if adjuvant (chemo)radiation is associated with a disease-free survival benefit after radical surgery in patients with intermediate risk cervical cancer. The primary endpoint of the study is the disease-free survival from the day of randomisation. A total of 514 patients are required to achieve 80% power on 5% significance level with non-inferiority margin of 5% to test the difference between the ARMs using Cox proportional hazards model. The maximal tolerated margin for non-inferiority in 2-year DFS is 5% (including expected drop-out rate of 10%).

Key Facts

Lead Sponsor

The Central and Eastern European Gynecologic Oncology Group

Enrollment

514

Start Date

2022-06-10

Completion Date

2029-12-01

Study Type

INTERVENTIONAL

Official Title

An International Randomised Trial of Radical Surgery Followed by Adjuvant (Chemo)Radiation Versus no Further Treatment in Patients With Early-stage, Intermediate-risk Cervical Cancer Patients

Interventions

No adjuvant therapyAdjuvant radiotherapy

Conditions

Cervical Cancer

Eligibility

Age Range

18 Years – 85 Years

Sex

FEMALE

Inclusion Criteria:

* Pathologically confirmed invasive cervical cancer
* FIGO IB1-IIA
* Squamous cell cancer or HPV-related adenocarcinoma
* Presence of tumour-related risk factors as follows:

  1. tumour ≥4 cm OR
  2. tumour\>2 cm \<4 cm AND lymphovascular space invasion OR
  3. tumour \>2 cm \<4 cm AND tumour free distance \<3 mm OR
  4. tumour \>2 cm \<4 cm AND deep stromal invasion (\>2/3)
* No evidence of suspicious pelvic lymph nodes or distant metastases on imaging (by radiological subjective assessment before surgery and negative pelvic LN on final pathology)
* ECOG performance status 0-1
* Deemed suitable and fit for radical surgery followed by adjuvant radiotherapy
* Negative pregnancy test (if applicable)
* Negative HIV test (only performed in high-risk countries or patients who have moved from those countries within the past 10 years)

Exclusion Criteria:

* Adenosquamous cancer or adenocarcinoma unusual type (non-HPV related - such as: mucinous, clear cell, mesonephric) or other rare tumour types (those not listed in the inclusion criteria)
* Inconclusive primary site of disease
* Unequivocally positive lymph node by imaging (by radiological subjective assessment)
* FIGO \<IB1 / \>IIA
* Previous pelvic malignancy
* History of second primary cancer outside pelvis if ≤ 3 years complete clinical remission (CCR)
* Previous pelvic radiotherapy
* Neoadjuvant chemotherapy prior surgical treatment
* Low likelihood of patient compliance to the follow-up

Outcome Measures

Primary Outcomes

Disease-free survival

Calculated as an interval from the day of randomisation until diagnosis of recurrence: (a) unequivocal finding on imaging by subjective radiological assessment; b) suspicious recurrence on imaging either confirmed by biopsy or supported by other signs (disease progression on imaging or progression of symptoms); (c) physical examination supported by clinical evidence (i.e., symptoms or progression); or (d) death caused by disease or death of unknown cause.

Time frame: Analysed 3 years after randomization of the last patient.

Secondary Outcomes

Overall survival

Time frame: Analysed 6 years after randomization of the last patient.

Pelvic disease-free survival

Time frame: Analysed 3 years after randomization of the last patient.

Health-related quality of life based questionnaire

The analysis will be made based on EORTC validated questionnaires and developed qualitative CERVANTES questionnaire.

Time frame: Analysed 3 years after randomization of the last patient.

Treatment-related adverse events based on Common Terminology Criteria for Adverse Events v5.0

Time frame: Analysed 3 years after randomization of the last patient.

Locations

General University Hospital in Prague, Prague, Czechia

Linked Papers

2021-05-06

Role of adjuvant radiation therapy after radical hysterectomy in patients with stage IB cervical carcinoma and intermediate risk factors

To investigate the outcomes of observation-alone versus adjuvant radiotherapy for patients with lymph node negative FIGO 2018 stage IB cervical carcinoma following radical hysterectomy with negative prognostic factors. The National Cancer Database was accessed and patients with no history of another tumor, diagnosed with intermediate risk (defined as tumor size 2-4 cm with lymph-vascular invasion or tumor size >4 cm) pathological stage IB squamous, adenosquamous carcinoma or adenocarcinoma of the cervix between January 2010 and December 2015 who underwent radical hysterectomy with lymphadenectomy and had negative tumor margins were identified. Overall survival was assessed following generation of Kaplan-Meier curves and compared with the log-rank test. A Cox model was constructed to control for a priori selected confounders known to be associated with overall survival. A total of 765 patients were identified and adjuvant external beam radiotherapy was administered to 378 patients (49.4%). There was no difference in overall survival between patients who did and did not receive adjuvant radiotherapy, P=0.44: 4-year overall survival rates were 88.4% and 87.1% respectively. After controlling for patient age, histology, and surgical approach, the administration of adjuvant radiotherapy was not associated with better survival (HR 0.86, 95% CI 0.54 to 1.38). For patients who received adjuvant radiotherapy, there was no survival difference between those who did (n=219) and did not (n=159) receive concurrent chemotherapy, P=0.36: 4-year overall survival rates were 89.8% and 86.3%, respectively. In a large cohort of patients with lymph node negative, margin negative, stage IB cervical carcinoma, with negative prognostic factors, the administration of adjuvant external beam radiation therapy was not associated with a survival benefit compared with observation alone.

2020-12-14

Tumour-free distance: a novel prognostic marker in patients with early-stage cervical cancer treated by primary surgery

Abstract Background Models predicting recurrence risk (RR) of cervical cancer are used to tailor adjuvant treatment after radical surgery. The goal of our study was to compare available prognostic factors and to develop a prognostic model that would be easy to standardise and use in routine clinical practice. Methods All consecutive patients with early-stage cervical cancer treated by primary surgery in a single referral centre (01/2007–12/2016) were eligible if assessed by standardised protocols for pre-operative imaging and pathology. Fifteen prognostic markers were evaluated in 379 patients, out of which 320 lymph node (LN)-negative. Results The best predictive model for the whole cohort entailed a combination of tumour-free distance (TFD) ≤ 3.5 mm and LN positivity, which separated two subgroups with a substantially distinct RR 36% and 6.5%, respectively. In LN-negative patients, a combination of TFD ≤ 3.5 mm and adenosquamous tumour type separated a group of nine patients with RR 33% from the rest of the group with 6% RR. Conclusions A newly identified prognostic marker, TFD, surpassed all traditional tumour-related markers in the RR assessment. Predictive models combining TFD, which can be easily accessed on pre-operative imaging, with LN status or tumour type can be used in daily practice and can help to identify patients with the highest RR.

2020-12-10

Role of adjuvant therapy after radical hysterectomy in intermediate-risk, early-stage cervical cancer

Adjuvant treatment remains a controversial issue for intermediate-risk cervical cancer. The aim of this study was to compare the prognosis of patients who underwent no adjuvant treatment, pelvic radiotherapy alone, or concurrent chemoradiotherapy after radical hysterectomy for intermediate-risk, early-stage cervical cancer. Patients with stage IB1-IIA2 (FIGO 2009) cervical squamous cell carcinoma treated with radical hysterectomy and pelvic lymph node dissection, with negative lymph nodes, surgical margins, or parametria, who had combined intermediate risk factors as defined in the Gynecologic Oncology Group trial (GOG-92; Sedlis criteria) were included in the study. Recurrence-free survival and disease-specific survival were compared. Of 861 patients included in the analysis, 85 patients received no adjuvant treatment, 283 patients were treated with radiotherapy, and 493 patients with concurrent chemoradiotherapy. After a median follow-up of 63 months (IQR 45 to 84), adjuvant radiotherapy or concurrent chemoradiotherapy was not associated with a survival benefit compared with no adjuvant treatment. The 5-year recurrence-free survival and corresponding disease-specific survival were 87.1%, 84.2%, 89.6% (p=0.27) and 92.3%, 87.7%, 91.4% (p=0.20) in the no adjuvant treatment, radiotherapy alone, and concurrent chemoradiotherapy groups, respectively. Lymphovascular space invasion was the only independent prognostic factor for both recurrence-free survival and disease-specific survival. Additionally, significant heterogeneity exists in Sedlis criteria: higher risk of relapse (HR=1.88; 95% CI 1.19 to 2.97; p=0.007) and death (HR=2.36; 95% CI 1.41 to 3.95; p=0.001) occurred in patients with lymphovascular space invasion and deep 1/3 stromal invasion compared with no lymphovascular space invasion, middle or deep 1/3 stromal invasion, and tumor diameter ≥4 cm. Radical hysterectomy alone without adjuvant treatment may achieve a favorable survival for patients with intermediate-risk cervical cancer as defined by Sedlis criteria. Criteria for adjuvant treatment in patients without high risk factors need to be further evaluated.

2020-04-22

Comparison of no adjuvant treatment and radiotherapy in early‐stage cervical carcinoma with intermediate risk factors

AbstractObjectiveTo evaluate the results of receiving no adjuvant treatment (NAT) or radiotherapy after radical hysterectomy in patients with International Federation of Gynecology and Obstetrics 2018 Stage IB1–IB3 cervical cancer with intermediate risk factors.MethodsA retrospective cohort study was conducted at Baskent University School of Medicine's Department of Gynecology and Obstetrics in Ankara, Turkey between January 1, 2008, and December 31, 2016. In total, 134 women with at least two intermediate risk factors (positive LVSI, deep stromal invasion, and tumor size ≥4 cm) were included in the study. Patients were divided into two groups: NAT and radiotherapy.ResultsThere were 66 patients in the NAT group and 68 in the radiotherapy group. The median follow‐up time was 61.05 months. The 5‐year overall survival (OS) rates were similar in both groups (84.1% vs 82.9%, respectively; P=0.57), while the 5‐year disease‐free survival (DFS) rates were 80.2% and 78.2% in the NAT and radiotherapy groups, respectively (P=0.25). Most importantly, both groups had similar local recurrence rates: 8 (12.1%) in the NAT group and 9 (13.2%) in the radiotherapy group (P=0.82). Multivariant analyses showed that the only independent risk factor for recurrence was tumor size ≥4 cm with a hazard ratio of 2.4 (95% confidence interval 1.12–5.24; P=0.02).ConclusionAdjuvant treatment improved neither DFS nor local recurrence rates.

Linked Investigators

David Cibula

Dimitrios Nasioudis