Cervical CancerPhase 2NCT04121975
CCRT Combined With Endostar for the Treatment of Locally Advanced Cervical Cancer
A Phase 2 study testing Radiotherapy, Endostar and Cisplatin in people with Cervical Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
This was a prospective, single arm, phase 2 trial. Adult Patients with histologically confirmed locally advanced cervical cancer were enrolled to receive the treatment of concurrent chemoradiotherapy combined with Endostar. The primary endpoint was progression-free survival (PFS) rate at 1 year. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Radiotherapy, Endostar and Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to Aug 2022
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years old;
- Histologically confirmed to be cervical squamous cell carcinoma;
- Clinical stage IIB (need to have lymph node metastasis), IIIA, IIIB, IVA (2018 version of FIGO stage);
- The ECOG PS score is 0 or 1;
- At least one measurable (measured according to RECIST 1.1);
- No distant organ metastasis confirmed by abdominal CT, chest CT, bone ECT, etc;
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- This treatment must be the first course of treatment;
- The expected survival expectation is not less than 6 months;
- The main organ function meets the following criteria within 7 days before treatment:
- Blood routine examination standard (without blood transfusion within 14 days):
- hemoglobin (HB) ≥ 90g / L;
- neutrophil absolute value (ANC) ≥ 1.5 × 10 9 / L;
- platelets (PLT) ≥ 80 × 10 9 / L.
- Biochemical tests are subject to the following criteria:
- total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
- alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5 times ULN;
- serum creatinine (Cr) ≤ 1.5 times ULN or creatinine clearance (CCr) ≥ 60ml / min;
- Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%).
- Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy tests within 7 days prior to study enrollment And must be non-lactating patients; (11) Can understand the study and have signed an informed consent form;
Who cannot join
- Patients with distant metastases;
- Those suffering from other malignant tumors;
- Have received cancer-related treatment such as radiotherapy or chemotherapy before enrollment;
- Patients with contraindications to radiotherapy and chemotherapy, including serious infections or other complications such as severe cerebrovascular disease, mental illness and uncontrollable diabetes;
- During pregnancy or lactation;
- Those who have received targeted therapy;
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- Those who are in other drug trials;
- Those with serious heart disease, including: congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, severe heart valve disease, and refractory hypertension;
- It is known that there is a hypersensitivity reaction to any component contained in the Endostar formulation;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Hanmei Lou, PHD, +86-13456856364, louhm@zjcc.org.cn
About this study
Official title: Concurrent Chemoradiotherapy Combined With Endostar for the Treatment of Locally Advanced Cervical Cancer, a Prospective, Single Arm Study
This was a prospective, single arm, phase 2 trial. Adult Patients with histologically confirmed locally advanced cervical cancer were enrolled to receive the treatment of concurrent chemoradiotherapy combined with Endostar. The primary endpoint was progression-free survival (PFS) rate at 1 year. The secondary endpoints were PFS, overall survival (OS) and safety.
Read the detailed description
This was a prospective, single arm, phase 2 trial. Adult Patients with histologically confirmed locally advanced cervical cancer were enrolled to receive the treatment of concurrent chemoradiotherapy combined with Endostar. Radiotherapy was administered in 1.8-2.0 Gy fractions 5 times weekly to a total dose of 45-50 Gy. Endostar (30 mg/d) was administered on days 1-5 every two weeks for 4 cycles. Cisplatin (30-40 mg/m2) was administered day 1, 8, 15, 22 and 29. The primary endpoint was progression-free survival (PFS) rate at 1 year. The secondary endpoints were PFS, overall survival (OS) and safety.
- Conditions
- Cervical Cancer
- Being tested
- Radiotherapy, Endostar, Cisplatin
- 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.
RadiotherapyRadiation
Radiotherapy was administered in 1.8-2.0 Gy fractions 5 times weekly to a total dose of 45-50 Gy.
EndostarDrug
Also called Recombinant human endostatin
30 mg/d was administered on days 1-5 every two weeks for 4 cycles.
CisplatinDrug
30-40 mg/m2 was administered day 1, 8, 15, 22 and 29.
| Study group | Role | What they receive |
|---|---|---|
| Chemoradiotherapy | Experimental | Radiation:
Radiotherapy was administered in 1.8-2.0 Gy fractions 5 times weekly to a total dose of 45-50 Gy.
Drug: Endostar 30 mg/d was administered on days 1-5 every two weeks for 4 cycles.
Drug: Cisplatin 30-40 mg/m2 was administered day 1, 8, 15, 22 and 29. Receives: Radiation: Radiotherapy; Drug: Endostar; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival (PFS) rate at 1 year
The rates of patients who were progression free at 1-year after enrollment
Measured: 1 year
Secondary outcomes (3)
Progression-free survival
Progression-free survival (PFS) is defined as the time from enrollment to disease progression or death from any cause.
Measured: 2 year
Overall survival
Overall survival was defined as the time from enrollment to death from any cause
Measured: 2 year
Treatment-related adverse events as assessed by CTCAE v4.0
Treatment-related adverse events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start1 Aug 2019
- Primary completionAug 2021 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe 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
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanmei Lou, PHD, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121975
- Sponsor's protocol ID
- Endo-CC-01
- Status last verified
- Oct 2019
- First submitted
- 9 Oct 2019
- Last updated
- 10 Oct 2019
- 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 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Chemoradiotherapy Combined With Endostar for the Treatment of Locally Advanced Cervical Cancer, a Prospective, Single Arm Study
- ClinicalTrials.gov ID
- NCT04121975
- Acronym / sponsor ID
- Endo-CC-01
- Conditions
- Cervical Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 10 Oct 2019 (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.
This was a prospective, single arm, phase 2 trial. Adult Patients with histologically confirmed locally advanced cervical cancer were enrolled to receive the treatment of concurrent chemoradiotherapy combined with Endostar. The primary endpoint was progression-free survival (PFS) rate at 1 year. The secondary endpoints were PFS, overall survival (OS) and safety.
Detailed description
This was a prospective, single arm, phase 2 trial. Adult Patients with histologically confirmed locally advanced cervical cancer were enrolled to receive the treatment of concurrent chemoradiotherapy combined with Endostar. Radiotherapy was administered in 1.8-2.0 Gy fractions 5 times weekly to a total dose of 45-50 Gy. Endostar (30 mg/d) was administered on days 1-5 every two weeks for 4 cycles. Cisplatin (30-40 mg/m2) was administered day 1, 8, 15, 22 and 29. The primary endpoint was progression-free survival (PFS) rate at 1 year. The secondary endpoints were PFS, overall survival (OS) and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemoradiotherapy | Experimental | Radiation: Radiotherapy, Drug: Endostar, Drug: CisplatinRadiation: Radiotherapy was administered in 1.8-2.0 Gy fractions 5 times weekly to a total dose of 45-50 Gy. Drug: Endostar 30 mg/d was administered on days 1-5 every two weeks for 4 cycles. Drug: Cisplatin 30-40 mg/m2 was administered day 1, 8, 15, 22 and 29. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age from 18 to 65 years old;
- Histologically confirmed to be cervical squamous cell carcinoma;
- Clinical stage IIB (need to have lymph node metastasis), IIIA, IIIB, IVA (2018 version of FIGO stage);
- The ECOG PS score is 0 or 1;
- At least one measurable (measured according to RECIST 1.1);
Key exclusion criteria (9 listed)
- Patients with distant metastases;
- Those suffering from other malignant tumors;
- Have received cancer-related treatment such as radiotherapy or chemotherapy before enrollment;
- Patients with contraindications to radiotherapy and chemotherapy, including serious infections or other complications such as severe cerebrovascular disease, mental illness and uncontrollable diabetes;
- During pregnancy or lactation;
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 |
|---|---|---|
| RadiotherapyRadiotherapy was administered in 1.8-2.0 Gy fractions 5 times weekly to a total dose of 45-50 Gy. | Radiation | Chemoradiotherapy |
| EndostarAlso: Recombinant human endostatin30 mg/d was administered on days 1-5 every two weeks for 4 cycles. | Drug | Chemoradiotherapy |
| Cisplatin30-40 mg/m2 was administered day 1, 8, 15, 22 and 29. | Drug | Chemoradiotherapy |
Primary outcome
progression-free survival (PFS) rate at 1 year
Time frame: 1 year
The rates of patients who were progression free at 1-year after enrollment
3 secondary outcomes
Progression-free survival
Time frame: 2 year
Overall survival
Time frame: 2 year
Treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
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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.
Hanmei Lou, PHD principal investigator
Zhejiang Cancer Hospital
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 Radiotherapy, Endostar and Cisplatin in people with Cervical Cancer, run by Zhejiang Cancer Hospital 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 19 inclusion and 9 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 10 Oct 2019. 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 Hanmei Lou, PHD (+86-13456856364, louhm@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (PFS) rate at 1 year (time frame: 1 year). 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 10 Oct 2019.