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

Primary Purpose

Uterine Cervical Neoplasms

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Chemoradiotherapy+ Endostar
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Cervical Neoplasms focused on measuring Adjuvant therapy, chemoradiotherapy, Uterine Cervical Neoplasms, high risk, Endostar

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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;

Sites / Locations

  • The Affiliated Suzhou Hospital of Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemoradiotherapy + Endostar

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
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).
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.
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.
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.

Full Information

First Posted
July 31, 2018
Last Updated
August 10, 2018
Sponsor
Nanjing Medical University
Collaborators
Second Affiliated Hospital of Soochow University
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1. Study Identification

Unique Protocol Identification Number
NCT03622827
Brief Title
Postoperative Concurrent Chemoradiotherapy Combined With Endostar for High-risk Early Stage Cervical Cancer
Acronym
ChESS
Official Title
Postoperative Concurrent Chemoradiotherapy Combined With Recombinant Human Endostatin for High-risk Early Stage Cervical Cancer: A Phase II Pilot Study (ChESS).
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2018 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
July 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Medical University
Collaborators
Second Affiliated Hospital of Soochow University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a pilot phase 2, single arm study to assess the efficacy and safety of concurrent chemoradiotherapy combined with recombinant human endostatin (Endostar) in early stage cervical cancer patients with high risk factor(s). Postoperative 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 prescription dose of 45-50Gy to PTV region. The external beam radiotherapy should be completed within 6 weeks. Concurrent chemotherapy consists 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. Recombinant human endostatin (Endostar,15mg/m2/d, civ, d1-7) is applied 3 days before the concurrent chemoradiotherapy for 2 cycles every 3 weeks. Aimed to recruit total of 120 cases in this single arm study. The primary endpoint is 3-year disease-free survival and acute toxicity. Secondary endpoints include time to distant metastasis survival, local-regional recurrence free survival, 3 and 5-year overall survival, and safety and tolerability. Quality of life will be evaluated with EORTC-Q30.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Neoplasms
Keywords
Adjuvant therapy, chemoradiotherapy, Uterine Cervical Neoplasms, high risk, Endostar

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chemoradiotherapy + Endostar
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Chemoradiotherapy+ Endostar
Intervention Description
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.
Primary Outcome Measure Information:
Title
3-year Disease-free survival
Description
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
Title
Acute toxicity
Description
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 Outcome Measure Information:
Title
Time to distant metastasis survival
Description
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
Title
Local-regional recurrence free survival
Description
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
Title
3-year overall survival rate
Description
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
Title
5-year overall survival rate
Description
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
Title
Quality of Life (QoL)
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ke Gu, M.D., Ph.D
Phone
86-13405070898
Email
dr.guke@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiliang Ding, M.D.
Phone
86-18913535515
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ke Gu, M.D., Ph.D
Organizational Affiliation
The Affiliated Suzhou Hospital of Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated Suzhou Hospital of Nanjing Medical University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ke Gu, M.D., Ph.D
Phone
86-13405070898
Email
dr.guke@hotmail.com
First Name & Middle Initial & Last Name & Degree
Zhiliang Ding, M.D.
Phone
86-18913535515

12. IPD Sharing Statement

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

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