Uterine Cervical NeoplasmsPhase 2ChESSNCT03622827
Postoperative Concurrent Chemoradiotherapy Combined With Endostar for High-risk Early Stage Cervical Cancer
A Phase 2 study testing Chemoradiotherapy+ Endostar in people with Uterine Cervical Neoplasms, run by Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Uterine Cervical Neoplasms
- What is being tested?
- Chemoradiotherapy+ Endostar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2018to 30 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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;
Trial locations and contacts
1 site in 1 country.
Zhiliang Ding, M.D. contact
China1 site, 1 recruiting
- Recruiting
The Affiliated Suzhou Hospital of Nanjing Medical University
Suzhou, Jiangsu, 215001
Ke Gu, M.D., Ph.D, 86-13405070898, dr.guke@hotmail.com
Zhiliang Ding, M.D., 86-18913535515
About this study
Official title: Postoperative Concurrent Chemoradiotherapy Combined With Recombinant Human Endostatin for High-risk Early Stage Cervical Cancer: A Phase II Pilot Study (ChESS).
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.
Read the 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.
- Conditions
- Uterine Cervical Neoplasms
- Being tested
- Chemoradiotherapy+ Endostar
- Keywords
- Adjuvant therapy, chemoradiotherapy, Uterine Cervical Neoplasms, high risk, Endostar
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Chemoradiotherapy+ Endostar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months
Secondary outcomes (5)
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start31 Jul 2018
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital of Soochow University
- Responsible party
- Principal investigator, Ke Gu, Nanjing Medical University
- Investigators
- Ke Gu, M.D., Ph.D, Principal investigator, The Affiliated Suzhou Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622827
- Sponsor's protocol ID
- K2018009
- Acronym
- ChESS
- Status last verified
- Aug 2018
- First submitted
- 31 Jul 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Concurrent Chemoradiotherapy Combined With Recombinant Human Endostatin for High-risk Early Stage Cervical Cancer: A Phase II Pilot Study (ChESS).
- ClinicalTrials.gov ID
- NCT03622827
- Acronym / sponsor ID
- ChESS / K2018009
- Conditions
- Uterine Cervical Neoplasms
- Keywords
- Adjuvant therapy, chemoradiotherapy, Uterine Cervical Neoplasms, high risk, Endostar
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Soochow University
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemoradiotherapy + Endostar | Experimental | Combination Product: Chemoradiotherapy+ EndostarChemoradiotherapy 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemoradiotherapy+ EndostarChemoradiotherapy 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. | Combination product | Chemoradiotherapy + Endostar |
Primary outcome
3-year Disease-free survival
Time frame: 3 years
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
Time frame: 3 months
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.
5 secondary outcomes
Time to distant metastasis survival
Time frame: 3 years
Local-regional recurrence free survival
Time frame: 3 years
3-year overall survival rate
Time frame: 3 years
5-year overall survival rate
Time frame: 5 years
Quality of Life (QoL)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhiliang Ding, M.D. contact
Ke Gu, M.D., Ph.D principal investigator
The Affiliated Suzhou Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chemoradiotherapy+ Endostar in people with Uterine Cervical Neoplasms, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ke Gu, M.D., Ph.D (86-13405070898, dr.guke@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year Disease-free survival (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.