Nasopharyngeal CarcinomaPhase 2NCT02237924

Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Nasopharyngeal Carcinoma

A Phase 2 study testing endostar, DDP and IMRT in people with Nasopharyngeal Carcinoma, run by First Affiliated Hospital of Guangxi Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Nasopharyngeal Carcinoma
What is being tested?: endostar, DDP and IMRT
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteChina
Study dates: Sep 2014to Jan 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 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

patients of either gender and aged from 18 to 70 years old.
patients with histologically confirmed non-keratinizing squamous cell nasopharyngeal carcinoma.
patients at stage III/IVM0 by UICC2010 staging; patients with higher risk factors (such as N3 and T4N2-phase lymph node ≥4 cm) were excluded.
KPS ≥ 70 (Appendix I)
patients with available MRI data of nasopharynx and measurable tumor lesions.
patients did not receive any treatment before enrollment.

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patients with expected survival longer than 6 months.
biochemical indexes: hemoglobin > 120 g/L, WBC > 4 x 109 /L, and blood platelet ≥ 100 x 109 /L; levels of indicators for hepatic and renal function was 1.25 folds of the upper limit of normal value.
the informed content was obtained from every patient.
patients with effective follow-up.

Who cannot join

those with malignant tumors other than nasopharyngeal carcinoma, stage I non-melanoma skin cancer, and cervical carcinoma in situ.
those received treatments before enrollment.
pregnant or lactating women and reproductive women without contraception.
those who were undergoing other drug trials.
those with severe complications, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, mental illness and uncontrollable diabetes.
those who could not be followed up at regular intervals.

Show all 10Show fewer

those who were treated with tumor targeting drugs.
those who could not subject to MRI examination.
those who could not meet the requirements of the prescribed dose.
those with hemorrhagic tendency.

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021

Other trials in China

About this study

Official title: Effect of Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Locoregionally Advanced,Low-risk Nasopharyngeal Carcinoma.

A total of 120 patients with pathologically confirmed locally advanced low-risk nasopharyngeal carcinoma were enrolled. They were randomly divided into two groups, with 60 patients in each group. One group was treated with intensity-modulated radiation therapy (IMRT) combined with Endostar and the other group was treated with IMRT combined with concurrent chemotherapy. The short term efficacy and the toxic and side effects of these treatments were evaluated. The 1-year, 3-year, 5-year overall survival and progression-free survival of patients were analyzed. Our data may provide an alternative option for the treatment of locally advanced low-risk nasopharyngeal carcinoma with high efficacy and low toxicity.

Read the detailed description

This study was a multicenter, open-label, randomized controlled clinical trial. A set of unified standards were used, including the clinical research program, inclusion criteria, exclusion criteria, chemoradiotherapy regimen and evaluation criteria. Nine medical centers participated in this study and 120 patients with pathologically confirmed locally advanced low-risk nasopharyngeal carcinoma were enrolled. These patients were stratified according to clinical stage and participating center, and were randomly divided into two groups: IMRT combined with Endostar group ( IMRT 70-74Gy, Endostar 7.5mg / m2, 2 cycles of continuous intravenous pumping, and 2 cycles of maintenance therapy after radiotherapy) and IMRT combined with concurrent chemotherapy group ( IMRT 70-74Gy, DDP 100mg / m2, intravenous infusion over 2 hours , for 2-3 cycles). After treatment, follow-up was performed every 3 months. The treatment toxicity, local control rate, distant metastasis-free survival, overall survival, progression-free survival were observed and assessed.

Conditions: Nasopharyngeal Carcinoma
Being tested: endostar, DDP, IMRT
Keywords: nasopharyngeal carcinoma, endostar, IMRT, chemoradiation
Medical subject headings: Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

endostarDrug
Endostar 7.5mg / m2, 2 cycles of continuous intravenous pumping for ten days,and 2 cycles of maintenance therapy after radiotherapy
DDPDrug
DDP:100mg/m2 for 2-3 cycles
IMRTRadiation
IMRT:70-74Gy for 2-3 cycles

Study groups in NCT02237924
Study group	Role	What they receive
endostar + IMRT	Experimental	Not described Receives: Drug: endostar; Radiation: IMRT
DDP + IMRT	Active comparator	Not described Receives: Drug: DDP; Radiation: IMRT

What is being measured

The primary outcome is the main question the study is designed to answer.

5-year Overall Survival
The subjects were randomly divided into two groups. Group A: IMRT combined with Endostar ，including 2 cycles of continuous intravenous pumping, and 2 cycles of maintenance therapy after radiotherapy，and Group B: IMRT combined with concurrent chemotherapy for 2 or 3 cycles. After treatment, the subjects go to observation period for 5 years.
Measured: 6 years

Secondary outcomes (1)

3-year Progression Free Survival
The subjects were randomly divided into two groups. Group A: IMRT combined with Endostar ，including 2 cycles of continuous intravenous pumping, and 2 cycles of maintenance therapy after radiotherapy，and Group B: IMRT combined with concurrent chemotherapy for 2 or 3 cycles. After treatment, the subjects go into observation period. MRI will be used for evaluating the carcinoma status. During 3 years, any relapse or death will be recorded.
Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Jan 2022

First posted12 Sep 2014 (estimated)
Study startSep 2014
Primary completionSep 2021
Study completionJan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02237924
Sponsor's protocol ID: S201413__19
Status last verified: Jan 2022
First submitted: 9 Sep 2014
Last updated: 14 Feb 2022
Results posted: No
Data monitoring committee: Yes

Publications

Lee AW, Sze WM, Au JS, Leung SF, Leung TW, Chua DT, Zee BC, Law SC, Teo PM, Tung SY, Kwong DL, Lau WH. Treatment results for nasopharyngeal carcinoma in the modern era: the Hong Kong experience. Int J Radiat Oncol Biol Phys. 2005 Mar 15;61(4):1107-16. doi: 10.1016/j.ijrobp.2004.07.702.
PubMed 15752890
Yeh SA, Tang Y, Lui CC, Huang YJ, Huang EY. Treatment outcomes and late complications of 849 patients with nasopharyngeal carcinoma treated with radiotherapy alone. Int J Radiat Oncol Biol Phys. 2005 Jul 1;62(3):672-9. doi: 10.1016/j.ijrobp.2004.11.002.
PubMed 15936544
Yi JL, Gao L, Huang XD, Li SY, Luo JW, Cai WM, Xiao JP, Xu GZ. Nasopharyngeal carcinoma treated by radical radiotherapy alone: Ten-year experience of a single institution. Int J Radiat Oncol Biol Phys. 2006 May 1;65(1):161-8. doi: 10.1016/j.ijrobp.2005.12.003. Epub 2006 Mar 20.
PubMed 16542792
Lee NY, Zhang Q, Pfister DG, Kim J, Garden AS, Mechalakos J, Hu K, Le QT, Colevas AD, Glisson BS, Chan AT, Ang KK. Addition of bevacizumab to standard chemoradiation for locoregionally advanced nasopharyngeal carcinoma (RTOG 0615): a phase 2 multi-institutional trial. Lancet Oncol. 2012 Feb;13(2):172-80. doi: 10.1016/S1470-2045(11)70303-5. Epub 2011 Dec 15.
PubMed 22178121
Pow EH, Kwong DL, McMillan AS, Wong MC, Sham JS, Leung LH, Leung WK. Xerostomia and quality of life after intensity-modulated radiotherapy vs. conventional radiotherapy for early-stage nasopharyngeal carcinoma: initial report on a randomized controlled clinical trial. Int J Radiat Oncol Biol Phys. 2006 Nov 15;66(4):981-91. doi: 10.1016/j.ijrobp.2006.06.013.
PubMed 17145528
Chan AT, Teo PM, Ngan RK, Leung TW, Lau WH, Zee B, Leung SF, Cheung FY, Yeo W, Yiu HH, Yu KH, Chiu KW, Chan DT, Mok T, Yuen KT, Mo F, Lai M, Kwan WH, Choi P, Johnson PJ. Concurrent chemotherapy-radiotherapy compared with radiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: progression-free survival analysis of a phase III randomized trial. J Clin Oncol. 2002 Apr 15;20(8):2038-44. doi: 10.1200/JCO.2002.08.149.
PubMed 11956263
Lee AW, Lau WH, Tung SY, Chua DT, Chappell R, Xu L, Siu L, Sze WM, Leung TW, Sham JS, Ngan RK, Law SC, Yau TK, Au JS, O'Sullivan B, Pang ES, O SK, Au GK, Lau JT; Hong Kong Nasopharyngeal Cancer Study Group. Preliminary results of a randomized study on therapeutic gain by concurrent chemotherapy for regionally-advanced nasopharyngeal carcinoma: NPC-9901 Trial by the Hong Kong Nasopharyngeal Cancer Study Group. J Clin Oncol. 2005 Oct 1;23(28):6966-75. doi: 10.1200/JCO.2004.00.7542.
PubMed 16192584
Wen QL, Meng MB, Yang B, Tu LL, Jia L, Zhou L, Xu Y, Lu Y. Endostar, a recombined humanized endostatin, enhances the radioresponse for human nasopharyngeal carcinoma and human lung adenocarcinoma xenografts in mice. Cancer Sci. 2009 Aug;100(8):1510-9. doi: 10.1111/j.1349-7006.2009.01193.x. Epub 2009 May 21.
PubMed 19459845

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Locoregionally Advanced,Low-risk Nasopharyngeal Carcinoma.
ClinicalTrials.gov ID: NCT02237924
Acronym / sponsor ID: S201413__19
Conditions: Nasopharyngeal Carcinoma
Keywords: nasopharyngeal carcinoma, endostar, IMRT, chemoradiation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: First Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
Study start: Sep 2014
Primary completion: Sep 2021 (actual)
Study completion: Jan 2022 (actual)
First posted: 12 Sep 2014 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
endostar + IMRT	Experimental	Drug: endostar, Radiation: IMRT
DDP + IMRT	Active comparator	Drug: DDP, Radiation: IMRT

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

patients of either gender and aged from 18 to 70 years old.
patients with histologically confirmed non-keratinizing squamous cell nasopharyngeal carcinoma.
patients at stage III/IVM0 by UICC2010 staging; patients with higher risk factors (such as N3 and T4N2-phase lymph node ≥4 cm) were excluded.
KPS ≥ 70 (Appendix I)
patients with available MRI data of nasopharynx and measurable tumor lesions.

Key exclusion criteria (10 listed)

those with malignant tumors other than nasopharyngeal carcinoma, stage I non-melanoma skin cancer, and cervical carcinoma in situ.
those received treatments before enrollment.
pregnant or lactating women and reproductive women without contraception.
those who were undergoing other drug trials.
those with severe complications, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, mental illness and uncontrollable diabetes.

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
endostarEndostar 7.5mg / m2, 2 cycles of continuous intravenous pumping for ten days,and 2 cycles of maintenance therapy after radiotherapy	Drug	endostar + IMRT
DDPDDP:100mg/m2 for 2-3 cycles	Drug	DDP + IMRT
IMRTIMRT:70-74Gy for 2-3 cycles	Radiation	DDP + IMRT, endostar + IMRT

Primary outcome

5-year Overall Survival
Time frame: 6 years
The subjects were randomly divided into two groups. Group A: IMRT combined with Endostar ，including 2 cycles of continuous intravenous pumping, and 2 cycles of maintenance therapy after radiotherapy，and Group B: IMRT combined with concurrent chemotherapy for 2 or 3 cycles. After treatment, the subjects go to observation period for 5 years.

1 secondary outcome

3-year Progression Free Survival
Time frame: 4 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
Background: PubMed 15752890Lee AW, Sze WM, Au JS, Leung SF, Leung TW, Chua DT, Zee BC, Law SC, Teo PM, Tung SY, Kwong DL, Lau WH. Treatment results for nasopharyngeal carcinoma in the modern era: the Hong Kong experience. Int J Radiat Oncol Biol Phys. 2005 Mar 15;61(4):1107-16. doi: 10.1016/j.ijrobp.2004.07.702.
Background: PubMed 15936544Yeh SA, Tang Y, Lui CC, Huang YJ, Huang EY. Treatment outcomes and late complications of 849 patients with nasopharyngeal carcinoma treated with radiotherapy alone. Int J Radiat Oncol Biol Phys. 2005 Jul 1;62(3):672-9. doi: 10.1016/j.ijrobp.2004.11.002.
Background: PubMed 16542792Yi JL, Gao L, Huang XD, Li SY, Luo JW, Cai WM, Xiao JP, Xu GZ. Nasopharyngeal carcinoma treated by radical radiotherapy alone: Ten-year experience of a single institution. Int J Radiat Oncol Biol Phys. 2006 May 1;65(1):161-8. doi: 10.1016/j.ijrobp.2005.12.003. Epub 2006 Mar 20.
Background: PubMed 22178121Lee NY, Zhang Q, Pfister DG, Kim J, Garden AS, Mechalakos J, Hu K, Le QT, Colevas AD, Glisson BS, Chan AT, Ang KK. Addition of bevacizumab to standard chemoradiation for locoregionally advanced nasopharyngeal carcinoma (RTOG 0615): a phase 2 multi-institutional trial. Lancet Oncol. 2012 Feb;13(2):172-80. doi: 10.1016/S1470-2045(11)70303-5. Epub 2011 Dec 15.
Background: PubMed 17145528Pow EH, Kwong DL, McMillan AS, Wong MC, Sham JS, Leung LH, Leung WK. Xerostomia and quality of life after intensity-modulated radiotherapy vs. conventional radiotherapy for early-stage nasopharyngeal carcinoma: initial report on a randomized controlled clinical trial. Int J Radiat Oncol Biol Phys. 2006 Nov 15;66(4):981-91. doi: 10.1016/j.ijrobp.2006.06.013.
Background: PubMed 11956263Chan AT, Teo PM, Ngan RK, Leung TW, Lau WH, Zee B, Leung SF, Cheung FY, Yeo W, Yiu HH, Yu KH, Chiu KW, Chan DT, Mok T, Yuen KT, Mo F, Lai M, Kwan WH, Choi P, Johnson PJ. Concurrent chemotherapy-radiotherapy compared with radiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: progression-free survival analysis of a phase III randomized trial. J Clin Oncol. 2002 Apr 15;20(8):2038-44. doi: 10.1200/JCO.2002.08.149.
Background: PubMed 16192584Lee AW, Lau WH, Tung SY, Chua DT, Chappell R, Xu L, Siu L, Sze WM, Leung TW, Sham JS, Ngan RK, Law SC, Yau TK, Au JS, O'Sullivan B, Pang ES, O SK, Au GK, Lau JT; Hong Kong Nasopharyngeal Cancer Study Group. Preliminary results of a randomized study on therapeutic gain by concurrent chemotherapy for regionally-advanced nasopharyngeal carcinoma: NPC-9901 Trial by the Hong Kong Nasopharyngeal Cancer Study Group. J Clin Oncol. 2005 Oct 1;23(28):6966-75. doi: 10.1200/JCO.2004.00.7542.
Background: PubMed 19459845Wen QL, Meng MB, Yang B, Tu LL, Jia L, Zhou L, Xu Y, Lu Y. Endostar, a recombined humanized endostatin, enhances the radioresponse for human nasopharyngeal carcinoma and human lung adenocarcinoma xenografts in mice. Cancer Sci. 2009 Aug;100(8):1510-9. doi: 10.1111/j.1349-7006.2009.01193.x. Epub 2009 May 21.

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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.

Sheng ren Wang, doctor study director

First Affiliated Hospital of Guangxi 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 endostar, DDP and IMRT in people with Nasopharyngeal Carcinoma, run by First Affiliated Hospital of Guangxi 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 10 inclusion and 10 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: finished, as of the sponsor's last update on 14 Feb 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

5-year Overall Survival (time frame: 6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02237924, which also lists 8 linked publications.

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 Feb 2022.