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Nasopharyngeal CarcinomaPhase 1NCT04522050

Gemcitabine-based Induction Chemotherapy Combined With Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma

A Phase 1 study testing Gemcitabine combined with cisplatin induction chemotherapy and concurrent chemoradiotherapy with gemcitabine in people with Nasopharyngeal Carcinoma, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Researchers conduct the clinical trial (gemcitabine combined with cisplatin induction chemotherapy followed by concurrent chemoradiotherapy with gemcitabine for locally advanced nasopharyngeal carcinoma) to evaluate the safety and effectiveness of gemcitabine in patients with locally advanced nasopharyngeal carcinoma. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
Gemcitabine combined with cisplatin induction chemotherapy and concurrent chemoradiotherapy with gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteChina
Study dates
1 Oct 2018to 1 Dec 2024
Phase
Phase 1
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients with newly histologically confirmed non-keratinizing carcinoma (according to WHO histological type)
  • Tumor staged as Ⅲ-Ⅳa (according to the 8th AJCC edition staging system)
  • Age :18-60
  • Performance status: KPS > 70
  • Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) < 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) < 2.5×ULN, and bilirubin < ULN
  • Renal: creatinine clearance > 60ml/min
  • Adequate marrow: leucocyte count > 4×109/L, neutrophil count > 2×109/L, and platelet count > 100×109/L
  • Written informed consent

Who cannot join

  • History of allergy to related drugs
  • Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin)
  • History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume)
  • Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes
  • Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×ULN), and emotional disturbance

Trial locations and contacts

1 site in 1 country.

qi zeng, Doctor contact

18898534065

zengqi37@mail.sysu.edu.cn

siyang wang, Doctor contact

13570608929

13570608929@163.com

China1 site, 1 recruiting

  • The Fifth Affiliated Hospital of Sun Yat-sen University

    Zhuhai, Guangdong, 519000

    Qi Zeng, Doctor, 18898534065, zengqi37@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Multicenter and Prospective Clinical Trial of Gemcitabine-based Induction Chemotherapy Combined With Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma

Researchers conduct the clinical trial (gemcitabine combined with cisplatin induction chemotherapy followed by concurrent chemoradiotherapy with gemcitabine for locally advanced nasopharyngeal carcinoma) to evaluate the safety and effectiveness of gemcitabine in patients with locally advanced nasopharyngeal carcinoma.

Read the detailed description

Diagnosed as locally advanced nasopharyngeal carcinoma (stage III-IV), and pathologically confirmed as a differentiated or undifferentiated non-keratinizing nasopharyngeal carcinoma, the patient is eligible to participate in the study. Patients receive gemcitabine (1000mg/m² d1,8) and cisplatin (80mg/m², d1) every 3 weeks for 2 cycles before radiotherapy. And then intensity modulated radiotherapy (IMRT) is given a total dose of GTVnx 70Gy, GTVnd 66Gy, CTV1 60Gy and CTV2 54Gy for 33 times in total, concurrently with gemcitabine. The initial dose of gemcitabine is 25mg/m² once a week for 6 times. The patients are divided into 9 groups (25mg/m², 50mg/m², 100mg/m², 200mg/m², 300mg/m², 350mg/m², 400mg/m², 450mg/m², 500mg/m²) with 6 patients in each group. Considering about 20% of the cases of dropout, withdrawal, and loss to follow-up in clinical trials, a total of 65 cases are needed in this study. The efficacy is evaluated according to the European Solid Tumor Efficacy Evaluation Standard (RECIST1.1). After induction chemotherapy, radiotherapy, and 3 months after radiotherapy, nasopharyngeal endoscopy and magnetic resonance imaging of the would be reviewed for 1 year, 2 years, and 3 years to evaluate the curative effect. The chest CT, abdominal B-ultrasound, bone scan or PETCT examinations are reviewed to exclud distant metastases. Biopsy diagnosis can be performed for patients suspected of local residual and recurrence.

Being tested
Gemcitabine combined with cisplatin induction chemotherapy, concurrent chemoradiotherapy with gemcitabine
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

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

  • Gemcitabine combined with cisplatin induction chemotherapyDrug

    Also called concurrent chemoradiotherapy with gemcitabine

    Patients receive gemcitabine (1000mg/m² d1,8) and cisplatin (80mg/m², d1) every 3 weeks for 2 cycles before radiotherapy. And then intensity modulated radiotherapy (IMRT) is given a total dose of GTVnx 70Gy, GTVnd 66Gy, CTV1 60Gy and CTV2 54Gy for 33 times in total, concurrently with gemcitabine. The initial dose of gemcitabine is 25mg/m² once a week for 6 times. The patients are divided into 9 groups (25mg/m², 50mg/m², 100mg/m², 200mg/m², 300mg/m², 350mg/m², 400mg/m², 450mg/m², 500mg/m²) with 6 patients in each group.

  • concurrent chemoradiotherapy with gemcitabineDrug

    followed by concurrent gemcitabine chemoradiotherapy

Study groups in NCT04522050
Study groupRoleWhat they receive
Induction chemotherapy + IMRT and concurrent gemcitabineOtherPatients receive gemcitabine (1000mg/m² d1,8) and cisplatin (80mg/m²,d1) every 3weeks for 2 cycles before radiotherapy, and then receive intensity modulated radiotherapy (IMRT) concurrently with gemcitabine. The initial dose of gemcitabine is 25mg/m² once a week for 6 times. Patients are divided into 9 groups (25mg/m², 50mg/m², 100mg/m², 200mg/m², 300mg/m², 350mg/m², 400mg/m², 450mg/m², 500mg/m²) with 6 patients in each group.
Receives: Drug: Gemcitabine combined with cisplatin induction chemotherapy; Drug: concurrent chemoradiotherapy with gemcitabine

What is being measured

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

  1. Maximum tolerance dose(MTD)

    MTD is detemined by the dose that is immediately lower than the dose that produced dose limiting toxicity （DLT）. If DLT occurs in more than half of patients at a certain dose level, the test will be terminated. If DLT occurs in 2 cases,another 6 patients will be treated with this dose. If DLT does not occur in 6 cases, the dose will continue to increase. If it still occurs, the next dose is MTD.

    Measured: 3 years

Secondary outcomes (2)

  1. Dose limiting toxicity (DLT)

    We determined DLT: a) grade ≥ 3 anemia; b) grade ≥ 3 thrombocytopenia; c) grade ≥ 3 neutropenia no less than 5 days, d) grade 3 febrile neutropenia (absolute neutrophil count < 1.0 x 10^9/L, fever ≥ 38.5℃) despite therapy with granulocyte colony-stimulating factor; and e) any other grades 3-4 toxicity (except alopecia and nausea).

    Measured: 3 years

  2. Tumor response rates

    Tumor response rate was evaluated according to the RECIST1.1. After induction chemotherapy, radiotherapy and 3 months, 1 year, 2 years, and 3 years of radiotherapy, nasal endoscope and magnetic resonance imaging results were used to evaluate the efficacy. And chest CT scanning, abdominal ultrasound, bone scan or PETCT examination were used to exclude the distant metastases. Pathologic biopsy can be performed for patients who are suspected of locally residual or recurrence.

    Measured: 3 years

Timeline

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

  1. First posted21 Aug 2020
  2. Study start1 Oct 2018
  3. Primary completion1 Oct 2024 (estimated)
  4. Study completion1 Dec 2024 (estimated)

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The initial dose of gemcitabine is 25mg/m² once a week for 6 times. The patients are divided into 9 groups (25mg/m², 50mg/m², 100mg/m², 200mg/m², 300mg/m², 350mg/m², 400mg/m², 450mg/m², 500mg/m²) with 6 patients in each group.
Masking
None (open label)
Enrolment
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04522050
Sponsor's protocol ID
ZDWY.TJZLK.111
Status last verified
Jun 2023
First submitted
15 Aug 2020
Last updated
12 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Jia WH, Huang QH, Liao J, Ye W, Shugart YY, Liu Q, Chen LZ, Li YH, Lin X, Wen FL, Adami HO, Zeng Y, Zeng YX. Trends in incidence and mortality of nasopharyngeal carcinoma over a 20-25 year period (1978/1983-2002) in Sihui and Cangwu counties in southern China. BMC Cancer. 2006 Jul 6;6:178. doi: 10.1186/1471-2407-6-178.

    PubMed 16822324

  • Zeng Q, Wang J, Lv X, Li J, Yin LJ, Xiang YQ, Guo X. Induction Chemotherapy Followed by Radiotherapy versus Concurrent Chemoradiotherapy in elderly patients with nasopharyngeal carcinoma: finding from a propensity-matched analysis. BMC Cancer. 2016 Aug 30;16(1):693. doi: 10.1186/s12885-016-2661-y.

    PubMed 27577729

  • Meng R, Wei K, Xia L, Xu Y, Chen W, Zheng R, Lin L. Cancer incidence and mortality in Guangdong province, 2012. Chin J Cancer Res. 2016 Jun;28(3):311-20. doi: 10.21147/j.issn.1000-9604.2016.03.05.

    PubMed 27478316

  • Peng G, Wang T, Yang KY, Zhang S, Zhang T, Li Q, Han J, Wu G. A prospective, randomized study comparing outcomes and toxicities of intensity-modulated radiotherapy vs. conventional two-dimensional radiotherapy for the treatment of nasopharyngeal carcinoma. Radiother Oncol. 2012 Sep;104(3):286-93. doi: 10.1016/j.radonc.2012.08.013. Epub 2012 Sep 17.

    PubMed 22995588

  • Zhang MX, Li J, Shen GP, Zou X, Xu JJ, Jiang R, You R, Hua YJ, Sun Y, Ma J, Hong MH, Chen MY. Intensity-modulated radiotherapy prolongs the survival of patients with nasopharyngeal carcinoma compared with conventional two-dimensional radiotherapy: A 10-year experience with a large cohort and long follow-up. Eur J Cancer. 2015 Nov;51(17):2587-95. doi: 10.1016/j.ejca.2015.08.006. Epub 2015 Aug 26.

    PubMed 26318726

  • Huang PY, Zeng Q, Cao KJ, Guo X, Guo L, Mo HY, Wu PH, Qian CN, Mai HQ, Hong MH. Ten-year outcomes of a randomised trial for locoregionally advanced nasopharyngeal carcinoma: A single-institution experience from an endemic area. Eur J Cancer. 2015 Sep;51(13):1760-70. doi: 10.1016/j.ejca.2015.05.025. Epub 2015 Jun 17.

    PubMed 26093812

  • Sun Y, Li WF, Chen NY, Zhang N, Hu GQ, Xie FY, Sun Y, Chen XZ, Li JG, Zhu XD, Hu CS, Xu XY, Chen YY, Hu WH, Guo L, Mo HY, Chen L, Mao YP, Sun R, Ai P, Liang SB, Long GX, Zheng BM, Feng XL, Gong XC, Li L, Shen CY, Xu JY, Guo Y, Chen YM, Zhang F, Lin L, Tang LL, Liu MZ, Ma J. Induction chemotherapy plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: a phase 3, multicentre, randomised controlled trial. Lancet Oncol. 2016 Nov;17(11):1509-1520. doi: 10.1016/S1470-2045(16)30410-7. Epub 2016 Sep 27.

    PubMed 27686945

  • Chua MLK, Wee JTS, Hui EP, Chan ATC. Nasopharyngeal carcinoma. Lancet. 2016 Mar 5;387(10022):1012-1024. doi: 10.1016/S0140-6736(15)00055-0. Epub 2015 Aug 28.

    PubMed 26321262

  • Ke LR, Xia WX, Qiu WZ, Huang XJ, Yang J, Yu YH, Liang H, Liu GY, Ye YF, Xiang YQ, Guo X, Lv X. Safety and efficacy of lobaplatin combined with 5-fluorouracil as first-line induction chemotherapy followed by lobaplatin-radiotherapy in locally advanced nasopharyngeal carcinoma: preliminary results of a prospective phase II trial. BMC Cancer. 2017 Feb 15;17(1):134. doi: 10.1186/s12885-017-3080-4.

    PubMed 28202000

  • Tang LQ, Chen DP, Guo L, Mo HY, Huang Y, Guo SS, Qi B, Tang QN, Wang P, Li XY, Li JB, Liu Q, Gao YH, Xie FY, Liu LT, Li Y, Liu SL, Xie HJ, Liang YJ, Sun XS, Yan JJ, Wu YS, Luo DH, Huang PY, Xiang YQ, Sun R, Chen MY, Lv X, Wang L, Xia WX, Zhao C, Cao KJ, Qian CN, Guo X, Hong MH, Nie ZQ, Chen QY, Mai HQ. Concurrent chemoradiotherapy with nedaplatin versus cisplatin in stage II-IVB nasopharyngeal carcinoma: an open-label, non-inferiority, randomised phase 3 trial. Lancet Oncol. 2018 Apr;19(4):461-473. doi: 10.1016/S1470-2045(18)30104-9. Epub 2018 Feb 28.

    PubMed 29501366

  • Vanderveken OM, Szturz P, Specenier P, Merlano MC, Benasso M, Van Gestel D, Wouters K, Van Laer C, Van den Weyngaert D, Peeters M, Vermorken J. Gemcitabine-Based Chemoradiation in the Treatment of Locally Advanced Head and Neck Cancer: Systematic Review of Literature and Meta-Analysis. Oncologist. 2016 Jan;21(1):59-71. doi: 10.1634/theoncologist.2015-0246. Epub 2015 Dec 28.

    PubMed 26712958

  • Zhang L, Huang Y, Hong S, Yang Y, Yu G, Jia J, Peng P, Wu X, Lin Q, Xi X, Peng J, Xu M, Chen D, Lu X, Wang R, Cao X, Chen X, Lin Z, Xiong J, Lin Q, Xie C, Li Z, Pan J, Li J, Wu S, Lian Y, Yang Q, Zhao C. Gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 trial. Lancet. 2016 Oct 15;388(10054):1883-1892. doi: 10.1016/S0140-6736(16)31388-5. Epub 2016 Aug 23.

    PubMed 27567279

  • Mason KA, Milas L, Hunter NR, Elshaikh M, Buchmiller L, Kishi K, Hittelman K, Ang KK. Maximizing therapeutic gain with gemcitabine and fractionated radiation. Int J Radiat Oncol Biol Phys. 1999 Jul 15;44(5):1125-35. doi: 10.1016/s0360-3016(99)00134-0.

    PubMed 10421547

  • Milas L, Fujii T, Hunter N, Elshaikh M, Mason K, Plunkett W, Ang KK, Hittelman W. Enhancement of tumor radioresponse in vivo by gemcitabine. Cancer Res. 1999 Jan 1;59(1):107-14.

    PubMed 9892194

  • El Deen DA, Toson EA, El Morsy SM. Gemcitabine-based induction chemotherapy and concurrent with radiation in advanced head and neck cancer. Med Oncol. 2012 Dec;29(5):3367-73. doi: 10.1007/s12032-012-0269-x. Epub 2012 Jun 8.

    PubMed 22678924

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Gemcitabine combined with cisplatin induction chemotherapy and concurrent chemoradiotherapy with gemcitabine in people with Nasopharyngeal Carcinoma, run by Fifth Affiliated Hospital, Sun Yat-Sen 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 8 inclusion and 5 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 12 Jul 2023. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 qi zeng, Doctor (18898534065, zengqi37@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerance dose(MTD) (time frame: 3 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 NCT04522050, which also lists 16 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 12 Jul 2023.

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