NCT03622827

Brief Summary

To assess the efficacy and safety of postoperative concurrent chemoradiotherapy combined with recombinant human endostatin (Endostar) in patients with high-risk early stage cervical cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

July 31, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

5 years

First QC Date

July 31, 2018

Last Update Submit

August 10, 2018

Conditions

Uterine Cervical Neoplasms

Keywords

Adjuvant therapychemoradiotherapyUterine Cervical Neoplasmshigh riskEndostar

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    3 months

Secondary Outcomes (5)

  • Time to distant metastasis survival

    3 years

  • Local-regional recurrence free survival

    3 years

  • 3-year overall survival rate

    3 years

  • 5-year overall survival rate

    5 years

  • Quality of Life (QoL)

    3 years

Study Arms (1)

Chemoradiotherapy + Endostar

EXPERIMENTAL

Chemoradiotherapy with Endostar： * Chemoradiotherapy: pelvic radiotherapy with concurrent chemotherapy that consisted of cisplatin (75 mg/m2, day 1-3) and 5-fluorouracil (5-FU; 1000mg/m2/day,civ, day 1-4) for 2 cycles every 3 weeks. * Endostar: recombinant human endostatin (15mg/m2/d, civ, d1-7) is given 3 days before the chemotherapy every 3 weeks, total of two cycles during chemoradiotherapy course.

Combination Product: Chemoradiotherapy+ Endostar

Interventions

Chemoradiotherapy+ EndostarCOMBINATION_PRODUCT

Chemoradiotherapy with Endostar： * Chemoradiotherapy: pelvic radiotherapy starts 2-3 weeks after surgery. 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. The external beam radiotherapy should be completed within 6 weeks. * Concurrent chemotherapy is consisted of cisplatin (75 mg/m2, day 1-3) and 5-fluorouracil (5-FU; 1000mg/m2/day, civ, day 1-4) for 2 cycles every 3 weeks. * Endostar: recombinant human endostatin (15mg/m2/d, civ, d1-7) is given 3 days before the concurrent chemoradiotherapy for 2 cycles every 3 weeks.

Chemoradiotherapy + Endostar

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Suzhou Hospital of Nanjing Medical University

Suzhou, Jiangsu, 215001, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Ke Gu, M.D., Ph.D

    The Affiliated Suzhou Hospital of Nanjing Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ke Gu, M.D., Ph.D

CONTACT

86-13405070898dr.guke@hotmail.com

Zhiliang Ding, M.D.

CONTACT

86-18913535515

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 31, 2018

First Posted

August 9, 2018

Study Start

July 31, 2018

Primary Completion

July 30, 2023

Study Completion

July 30, 2025

Last Updated

August 14, 2018

Record last verified: 2018-08

Locations

CN(1)