Postoperative treatment for high-risk early stage cervical cancer

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

This study is testing a new treatment that combines chemotherapy and radiation with a drug called Endostar to see if it helps people with high-risk early stage cervical cancer stay cancer-free after surgery.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Nanjing Medical University (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT03622827 on ClinicalTrials.gov

What this trial studies

This pilot phase 2 study evaluates the efficacy and safety of combining postoperative concurrent chemoradiotherapy with recombinant human endostatin (Endostar) in patients diagnosed with high-risk early stage cervical cancer. Participants will receive intensity-modulated radiotherapy and chemotherapy with cisplatin and 5-fluorouracil, alongside Endostar, starting 2-3 weeks after surgery. The study aims to recruit 120 patients and will assess disease-free survival, overall survival, and safety outcomes over a three-year period.

Who should consider this trial

Good fit: Ideal candidates include operable patients aged 18-70 with histologically confirmed high-risk cervical cancer who have undergone complete radical hysterectomy.

Not a fit: Patients with distant metastasis or those with non-squamous or non-adenocarcinoma types of cervical cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve disease-free survival rates and overall outcomes for patients with high-risk early stage cervical cancer.

How similar studies have performed: Other studies have shown promise in using concurrent chemoradiotherapy for cervical cancer, but the combination with Endostar is a novel approach.

Eligibility criteria

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;

Where this trial is running

Suzhou, Jiangsu

• The Affiliated Suzhou Hospital of Nanjing Medical University — Suzhou, Jiangsu, China (RECRUITING)

Study contacts

• Principal investigator: Ke Gu, M.D., Ph.D — The Affiliated Suzhou Hospital of Nanjing Medical University
• Study coordinator: Ke Gu, M.D., Ph.D

Conditions: Uterine Cervical Neoplasms, Adjuvant therapy, chemoradiotherapy, high risk, Endostar