Postoperative Concurrent Chemoradiotherapy Combined With Endostar for High-risk Early Stage Cervical Cancer

NCT03622827UNKNOWNPHASE2INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Nanjing Medical University

Enrollment

120

Start Date

2018-07-31

Completion Date

2023-07-30

Study Type

INTERVENTIONAL

Official Title

Postoperative Concurrent Chemoradiotherapy Combined With Recombinant Human Endostatin for High-risk Early Stage Cervical Cancer: A Phase II Pilot Study (ChESS).

Interventions

Chemoradiotherapy+ Endostar

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

18 Years – 70 Years

Sex

FEMALE

Inclusion Criteria:

* Aged between 18 and 70 years.
* Histologically confirmed adenocarcinoma or squamous cervical carcinomas.
* Chest CT scan and ultrasound must be done prior to surgery as to rule out distant metastasis.
* Operable patients with clinical diagnosis of FIGO stage IB-IIA cervical cancer.
* Complete radical hysterectomy of cervical cancer is mandatory. All gross diseases must have been removed at the end of surgery. All surgical margins of resection must be negative for tumor. Para-aortic lymph node sampling is performed according to gynaecologist decision.
* Patients with one of these risk factors:positive pelvic nodes, parametrial invasion, positive surgical margin.OR patients with at least two of following risk factors: tumor size≥4cm,lymphovascular space invasion,stromal invasion≥1/2.
* Performance status 0-2 (ECOG, Eastern Cooperative Oncology Group).
* Adequate organ function is needed, including cardio-respiratory, hepato-renal and hematological reserves: Absolute neutrophil count (ANC)≥1.5×109/L;Platelet count≥100×109/L; ASAT\&ALST\<1.5 times upper limit of normal (ULN) (With hepatic metastases, ASAT\&ALST\<5.0 times upper limit of normal);Bilirubin \<1.5 times ULN;Creatinine≤1.25×ULN or Creatinine clearance≥50 mL/min.
* Signed written informed consent prior to study entry.

Exclusion Criteria:

* Previous radiation or chemotherapy treatment or major pelvic surgery.
* Patients with distant metastasis confirmed by imaging or pathology.
* Other uncured malignant tumors in the past five years, except the cured skin basal cell carcinoma and breast carcinoma in situ.
* Any prior anticancer therapy.
* Unable to tolerate postoperative concurrent chemoradiotherapy.
* Patients with evidence of being allergic to fluorouracil, cisplatin or Endostar.
* Patients with serious comorbidity that might potentially influence the practice of protocol, including severe infection, myocardial infarction, severe arrhythmia, severe cerebrovascular disease, severe mental disorder, etc.
* Patients with Heart related adverse events or thrombotic events in the past 6 months.
* Patients with hepatitis B, hepatitis C and human immunodeficiency virus (HIV) or any other active viral infections.
* Participate in other clinical researchers.
* The estimated survival\<3 months;

Outcome Measures

Primary Outcomes

3-year Disease-free survival

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 three years.

Time frame: 3 years

Acute toxicity

Evaluate the treatment induced toxicity according to CTCAE 4.0 during the time of chemoradiotherapy and Endostar which starts from the first day of Endostar and lasts three months.

Time frame: 3 months

Secondary Outcomes

Time to distant metastasis survival

Determine the non-distant metastasis survival in early-stage cervical cancer patients with high risk factors, defined as time from the date of surgery to first distant metastasis event (determined by CT or MRI scan and/or pathologic disease on biopsy).

Time frame: 3 years

Local-regional recurrence free survival

Determine the local-regional recurrence free survival in early-stage cervical cancer patients with high risk factors, defined as time from the date of surgery to first local-regional recurrence event (determined by CT or MRI scan and/or pathologic disease on biopsy).

Time frame: 3 years

3-year overall survival rate

Determine the 3-year overall survival rate in early-stage cervical cancer patients with high risk factors, defined as time from the date of surgery to death of all cause at time of 3 years after operation.

Time frame: 3 years

5-year overall survival rate

Determine the 5-year overall survival rate in early-stage cervical cancer patients with high risk factors, defined as time from the date of surgery to death of all cause at time of 5 years after operation.

Time frame: 5 years

Quality of Life (QoL)

Collect QoL data on early-stage cervical cancer patients with high risk factors. The data is measured by EORTC QLQ-C30 (Version 3.0) according to investigator collection at the starting and ending time of the adjuvant treatment. EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. The core and disease-specific for cervix modules are selected to estimate treatment related influence on patients' life. The final score of the questionnaire is collected and analyzed according to detailed scoring procedures from manuals.

Time frame: 3 years

Locations

The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou, China