Nasopharyngeal CarcinomaPhase 2NCT02636231
Endostar for Locally Recurrent Nasopharyngeal Carcinoma
A Phase 2 study testing Endostatins and IMRT in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 8 sites in China.
Trial summary
The purpose of this study is to determine whether endostar and IMRT is effective in the treatment of locally recurrent nasopharyngeal carcinoma patients compared with IMRT alone. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Endostatins and IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 8 sitesChina
- Study dates
- Nov 2015to Dec 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically or clinically confirmed locally recurrent nasopharyngeal carcinoma;
- No evidence of distant metastasis
- More than 1 year from the end of the first course of radiotherapy
- Male, or female not in the phase of lactating or pregnancy
- ECOG 0-2
- Aged 18-70 years old
Show all 9Show fewer
- WBC count ≥4×109/L, neutrophile granulocyte count≥1.5×109/L, PLT count ≥100×109/L, Hb ≥9g/L
- Total bilirubin, AST, ALT≤2.0 times of upper normal limits; creatinine ≤1.5 times of upper normal limits
- Written informed consort signed
Who cannot join
- Only regionally recurrence
- Evidence of distant metastasis
- Prior invasive malignancy; noninvasive cancers (For example, carcinoma in situ of the bladder, oral cavity, or cervix are all permissible) are permitted
- Severe, active co-morbidity
- Prior anti-tumor treatment after diagnosis of local recurrence
- MRI was not performed 3 months after the first course of radiotherapy
Show all 9Show fewer
- Abnormal function of heart, brain and lungs, etc
- Lactation or pregnancy
- Severe nasopharyngeal mucosal necrosis at the diagnosis of local recurrence
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
First People's Hospital of Foshan
Foshan, Guangdong, 528000
The Affiliated GanZhou Hospital of NanChang University
Ganzhou, Jiangxi, 341000
The First Hospital of Gannan Medical University
Ganzhou, Jiangxi, 341000
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, 510000
The First Affiliated Hospital of Clinical Medicine of G.D.P.U.
Guangzhou, Guangdong, 510000
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
JiangXi Province Tumor Hospital
Nanchang, Jiangxi, 330029
About this study
Official title: A Phase II Randomized Controlled Study to Compare Endostar and IMRT vs. IMRT Alone for Locally Recurrent Nasopharyngeal Carcinoma Patients
The purpose of this study is to determine whether endostar and IMRT is effective in the treatment of locally recurrent nasopharyngeal carcinoma patients compared with IMRT alone.
Read the detailed description
Locally recurrent nasopharyngeal carcinoma (NPC) may be salvaged by intensity modulated-radiotherapy (IMRT), but severe late toxicities become the most common reason of death in IMRT salvaged NPC patients.
The aim of this phase II randomized controlled study is to address the efficacy of concurrent Endostar (Endostatins) with IMRT to reduce the occurrence of severe late toxicities compared with IMRT alone for locally recurrent NPC patients.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Endostatins, IMRT
- Keywords
- Endostar, IMRT, recurrent, NPC
- Medical subject headings
- Nasopharyngeal Carcinoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndostatinsDrug
Also called Endostar
Endostar (Endostatins) is to give from the first day of IMRT, 201mg, civ d1-14, q3w for two cycles.
IMRTRadiation
IMRT is to give GTV 60Gy in 27 fractions.
| Study group | Role | What they receive |
|---|---|---|
| IMRT and concurrent Endostar | Active comparator | IMRT and concurrent Endostar (Endostatins) to treat locally recurrent NPC patients; Endostar is to give from the first day of IMRT, 201mg, civ d1-14, q3w for two cycles.
IMRT is to give GTV 60Gy in 27 fractions. Receives: Drug: Endostatins; Radiation: IMRT |
| IMRT alone | Experimental | IMRT alone to treat locally recurrent NPC patients. IMRT is to give GTV 60Gy in 27 fractions. Receives: Radiation: IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with grade 4-5 late adverse events as assessed by RTOG/EORTC Late Radiation Morbidity Scoring Schema
Measured: From 3 months after the end of IMRT to 1 year after the end of IMRT
Secondary outcomes (2)
Number of participants with severe acute toxicities as assessed by CTCAE v3.0
Measured: From the beginning of IMRT to 3 months after the end of IMRT
Overall survival
Measured: From the beginning the IMRT to 3 year after the end of IMRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionMar 2020
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- JiangXi Province Tumor Hospital, The First Affiliated Hospital of Clinical Medicine of G.D.P.U., Second Affiliated Hospital of Nanchang University, First People's Hospital of Foshan, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, The Affiliated Ganzhou Hospital of Nanchang University, First Affiliated Hospital of Gannan Medical University
- Responsible party
- Principal investigator, Fei Han, Sun Yat-sen University
- Investigators
- Fei Han, M.D., Ph.D., Principal investigator, China: Ethics Committee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636231
- Sponsor's protocol ID
- NPC201501
- Status last verified
- Jan 2021
- First submitted
- 27 Feb 2015
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Han F, Zhao C, Huang SM, Lu LX, Huang Y, Deng XW, Mai WY, Teh BS, Butler EB, Lu TX. Long-term outcomes and prognostic factors of re-irradiation for locally recurrent nasopharyngeal carcinoma using intensity-modulated radiotherapy. Clin Oncol (R Coll Radiol). 2012 Oct;24(8):569-76. doi: 10.1016/j.clon.2011.11.010. Epub 2011 Dec 29.
PubMed 22209574Zhang K, Yang S, Zhu Y, Mo A, Zhang D, Liu L. Protection against acute radiation-induced lung injury: a novel role for the anti-angiogenic agent Endostar. Mol Med Rep. 2012 Aug;6(2):309-15. doi: 10.3892/mmr.2012.903. Epub 2012 May 4.
PubMed 22562140Peng F, Xu Z, Wang J, Chen Y, Li Q, Zuo Y, Chen J, Hu X, Zhou Q, Wang Y, Ma H, Bao Y, Chen M. Recombinant human endostatin normalizes tumor vasculature and enhances radiation response in xenografted human nasopharyngeal carcinoma models. PLoS One. 2012;7(4):e34646. doi: 10.1371/journal.pone.0034646. Epub 2012 Apr 9.
PubMed 22496834Tong RT, Boucher Y, Kozin SV, Winkler F, Hicklin DJ, Jain RK. Vascular normalization by vascular endothelial growth factor receptor 2 blockade induces a pressure gradient across the vasculature and improves drug penetration in tumors. Cancer Res. 2004 Jun 1;64(11):3731-6. doi: 10.1158/0008-5472.CAN-04-0074.
PubMed 15172975Tian YM, Guan Y, Xiao WW, Zeng L, Liu S, Lu TX, Zhao C, Han F. Long-term survival and late complications in intensity-modulated radiotherapy of locally recurrent T1 to T2 nasopharyngeal carcinoma. Head Neck. 2016 Feb;38(2):225-31. doi: 10.1002/hed.23880. Epub 2015 May 27.
PubMed 25244494
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Controlled Study to Compare Endostar and IMRT vs. IMRT Alone for Locally Recurrent Nasopharyngeal Carcinoma Patients
- ClinicalTrials.gov ID
- NCT02636231
- Acronym / sponsor ID
- NPC201501
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Endostar, IMRT, recurrent, NPC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- JiangXi Province Tumor Hospital, The First Affiliated Hospital of Clinical Medicine of G.D.P.U., Second Affiliated Hospital of Nanchang University, First People's Hospital of Foshan, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, The Affiliated Ganzhou Hospital of Nanchang University, First Affiliated Hospital of Gannan Medical University
- Study start
- Nov 2015 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 21 Dec 2015 (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.
The purpose of this study is to determine whether endostar and IMRT is effective in the treatment of locally recurrent nasopharyngeal carcinoma patients compared with IMRT alone.
Detailed description
Locally recurrent nasopharyngeal carcinoma (NPC) may be salvaged by intensity modulated-radiotherapy (IMRT), but severe late toxicities become the most common reason of death in IMRT salvaged NPC patients.
The aim of this phase II randomized controlled study is to address the efficacy of concurrent Endostar (Endostatins) with IMRT to reduce the occurrence of severe late toxicities compared with IMRT alone for locally recurrent NPC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMRT and concurrent Endostar | Active comparator | Drug: Endostatins, Radiation: IMRTIMRT and concurrent Endostar (Endostatins) to treat locally recurrent NPC patients; Endostar is to give from the first day of IMRT, 201mg, civ d1-14, q3w for two cycles. IMRT is to give GTV 60Gy in 27 fractions. |
| IMRT alone | Experimental | Radiation: IMRTIMRT alone to treat locally recurrent NPC patients. IMRT is to give GTV 60Gy in 27 fractions. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Pathologically or clinically confirmed locally recurrent nasopharyngeal carcinoma;
- No evidence of distant metastasis
- More than 1 year from the end of the first course of radiotherapy
- Male, or female not in the phase of lactating or pregnancy
- ECOG 0-2
Key exclusion criteria (9 listed)
- Only regionally recurrence
- Evidence of distant metastasis
- Prior invasive malignancy; noninvasive cancers (For example, carcinoma in situ of the bladder, oral cavity, or cervix are all permissible) are permitted
- Severe, active co-morbidity
- Prior anti-tumor treatment after diagnosis of local recurrence
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 |
|---|---|---|
| EndostatinsAlso: EndostarEndostar (Endostatins) is to give from the first day of IMRT, 201mg, civ d1-14, q3w for two cycles. | Drug | IMRT and concurrent Endostar |
| IMRTIMRT is to give GTV 60Gy in 27 fractions. | Radiation | IMRT alone, IMRT and concurrent Endostar |
Primary outcome
Number of participants with grade 4-5 late adverse events as assessed by RTOG/EORTC Late Radiation Morbidity Scoring Schema
Time frame: From 3 months after the end of IMRT to 1 year after the end of IMRT
2 secondary outcomes
Number of participants with severe acute toxicities as assessed by CTCAE v3.0
Time frame: From the beginning of IMRT to 3 months after the end of IMRT
Overall survival
Time frame: From the beginning the IMRT to 3 year after the end of IMRT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Results publication: PubMed 22209574Han F, Zhao C, Huang SM, Lu LX, Huang Y, Deng XW, Mai WY, Teh BS, Butler EB, Lu TX. Long-term outcomes and prognostic factors of re-irradiation for locally recurrent nasopharyngeal carcinoma using intensity-modulated radiotherapy. Clin Oncol (R Coll Radiol). 2012 Oct;24(8):569-76. doi: 10.1016/j.clon.2011.11.010. Epub 2011 Dec 29.
- Results publication: PubMed 22562140Zhang K, Yang S, Zhu Y, Mo A, Zhang D, Liu L. Protection against acute radiation-induced lung injury: a novel role for the anti-angiogenic agent Endostar. Mol Med Rep. 2012 Aug;6(2):309-15. doi: 10.3892/mmr.2012.903. Epub 2012 May 4.
- Results publication: PubMed 22496834Peng F, Xu Z, Wang J, Chen Y, Li Q, Zuo Y, Chen J, Hu X, Zhou Q, Wang Y, Ma H, Bao Y, Chen M. Recombinant human endostatin normalizes tumor vasculature and enhances radiation response in xenografted human nasopharyngeal carcinoma models. PLoS One. 2012;7(4):e34646. doi: 10.1371/journal.pone.0034646. Epub 2012 Apr 9.
- Results publication: PubMed 15172975Tong RT, Boucher Y, Kozin SV, Winkler F, Hicklin DJ, Jain RK. Vascular normalization by vascular endothelial growth factor receptor 2 blockade induces a pressure gradient across the vasculature and improves drug penetration in tumors. Cancer Res. 2004 Jun 1;64(11):3731-6. doi: 10.1158/0008-5472.CAN-04-0074.
- Results publication: PubMed 25244494Tian YM, Guan Y, Xiao WW, Zeng L, Liu S, Lu TX, Zhao C, Han F. Long-term survival and late complications in intensity-modulated radiotherapy of locally recurrent T1 to T2 nasopharyngeal carcinoma. Head Neck. 2016 Feb;38(2):225-31. doi: 10.1002/hed.23880. Epub 2015 May 27.
Related trials for Nasopharyngeal Carcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
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.
Fei Han, M.D., Ph.D. principal investigator
China: Ethics Committee
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Endostatins and IMRT in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 8 sites 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 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 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
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?
Number of participants with grade 4-5 late adverse events as assessed by RTOG/EORTC Late Radiation Morbidity Scoring Schema (time frame: From 3 months after the end of IMRT to 1 year after the end of IMRT). 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 NCT02636231, which also lists 5 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 3 Feb 2021.