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Acute Toxic EffectsPhase 1NCT03188497

Dose Escalation of Lobaplatin Concurrent With IMRT for the Treatment of NPC: A Phase I Clinical Trial

A Phase 1 study testing Lobaplatin and linear accelerator in people with Acute Toxic Effects and Tumor Responses, run by Fifth Affiliated Hospital, Sun Yat-Sen 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

Nasopharyngeal carcinoma (NPC) is a common malignant tumor in Southern China area, which is characterized by obvious regional characteristics and "Guangdong cancer". Radiotherapy is the main treatment for locally advanced nasopharyngeal carcinoma. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Acute Toxic Effects, Tumor Responses
What is being tested?
Lobaplatin and linear accelerator
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteChina
Study dates
22 Jun 2016to 20 Mar 2018
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The pathological type is non keratinized carcinoma (according to the pathological classification of World, Health, Organization, WHO)
  • Overall Stage III-IVB (according to the seventh edition of AJCC staging system).
  • Age between 18-65 years old.
  • There is no evidence of distant metastasis.
  • Eastern Cooperative Oncology Group performance status 0 or 1.
  • Normal marrow function: white blood count > 4 * 109/L, hemoglobin > 90g/L, and platelet count > 100 * 109/L.
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  • Normal liver function: total bilirubin (TBIL) and alanine aminotransferase (ALT) <2 times the normal values.
  • Normal renal function: creatinine (Cr) <1.5 times the normal value.
  • The patient must be the basic content of this research and the defendant signed the informed consent.

Who cannot join

  • The pathological type is WHO squamous cell carcinoma or squamous cell carcinoma.
  • Age > 65 years old, or < 18 yeas old.
  • The purpose of treatment is palliative.
  • There was a history of malignancy, except for adequately treated basal cell carcinoma or squamous cell carcinoma, and carcinoma in situ of the cervix.
  • Women who are pregnant or lactating (for women of child-bearing age) should consider pregnancy tests; effective contraception should be emphasized during treatment）.
  • Previously received radiation therapy .
  • Primary and neck metastases were treated with chemotherapy or surgery.
  • Accompanied by other serious diseases may pose a greater risk or impact on test compliance.

Trial locations and contacts

1 site in 1 country.

China1 site

  • the Fifth Hospital Affiliated to Sun Yat-Sen University

    Zhuhai, Guangdong, 519000

Other trials in China

About this study

Official title: Dose Escalation of Lobaplatin Concurrent With Intensity-modulated Radiotherapy for the Treatment of Stage III-IVb Nasopharyngeal Carcinoma: A Phase I Clinical Trial in an Asian Population

Nasopharyngeal carcinoma (NPC) is a common malignant tumor in Southern China area, which is characterized by obvious regional characteristics and "Guangdong cancer". Radiotherapy is the main treatment for locally advanced nasopharyngeal carcinoma. In recent years, chemotherapy has improved the short-term and long-term survival of patients with locally advanced nasopharyngeal carcinoma.

Lobaplatin is the third generation platinum anticancer drugs, mechanism of action and traditional cisplatin is similar, mainly formed by the Pt-GG and Pt-AG chain cross connect, replication and transcription process blocks of deoxyribonucleic acid(DNA), thereby interfering with tumor cell cycle. The damage of DNA induced by lobaplatin can influence the expression of tumor cell specific genes. Due to the different structure of lobaplatin and no cross resistance to cisplatin in the study showed that, compared with cisplatin with gastrointestinal reaction more mild, and no cisplatin common liver and kidney toxicity, neurotoxicity and ototoxicity, in some tumors have a better adaptability; but compared with cisplatin had more severe bone marrow suppression this, offset some of the advantages of lobaplatin in a certain extent. At present, the clinical indications for the treatment of such diseases include head and neck cancer, breast cancer, gastrointestinal cancer, gynecologic malignant tumor and non small cell lung cancer. Tian Ying confirmed that lobaplatin has obvious cytotoxic effect on nasopharyngeal carcinoma cells, in a concentration dependent manner, the mechanism for the dual role, namely block at lower concentration of cells in G2 phase and induce apoptosis at higher concentration, provide the possibility for clinical treatment of nasopharyngeal carcinoma for lobaplatin; there are a number of clinical study confirmed that lobaplatin chemoradiotherapy for locally advanced nasopharyngeal carcinoma with cisplatin approximation. But at present, there is no report on the dose and tolerability of concurrent radiotherapy for nasopharyngeal carcinoma.

Therefore, a dose escalation trial was conducted to determine maximum tolerated dose of lobaplat in as a single agent combined with concurrent intensity-modulated radiotherapy in a Chinese population with locoregionally advanced NPC.

Being tested
Lobaplatin, linear accelerator

What participants receive

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

  • LobaplatinDrug

    Lobaplatin for Injection

  • linear acceleratorDevice

    Medical linear accelerator

Study groups in NCT03188497
Study groupRoleWhat they receive
Experience group 1ExperimentalThe dose of lobaplatin is 25mg/m2 on d1,d22,d43.
Receives: Drug: Lobaplatin; Device: linear accelerator
Experience group 2ExperimentalThe dose of lobaplatin is on d1,d22,d43.
Receives: Drug: Lobaplatin; Device: linear accelerator
Experience group 3ExperimentalThe dose of lobaplatin is on d1,d22,d43.
Receives: Drug: Lobaplatin; Device: linear accelerator
Experience group 4ExperimentalThe dose of lobaplatin is 40mg/m2 on d1,d22,d43.
Receives: Drug: Lobaplatin; Device: linear accelerator
Experience group 5ExperimentalThe dose of lobaplatin is 45mg/m2 on d1,d22,d43.
Receives: Drug: Lobaplatin; Device: linear accelerator
Experience group 6ExperimentalThe dose of lobaplatin is 50mg/m2 on d1,d22,d43.
Receives: Drug: Lobaplatin; Device: linear accelerator

What is being measured

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

  1. Platelets

    grade 3: 25.0-< 50.0*109/L; grade 4:< 25.0*109/L.

    Measured: 1 years

  2. Leukocytes

    grade 3: 1.0-< 2.0*10^9/L; grade 4: < 1.0*10^9/L.

    Measured: 1 years

  3. Neutrophils

    grade 3: 0.5-< 1.0*10^9/L; grade 4: < 0.5*10^9/L.

    Measured: 1 years

  4. Hemoglobin

    grade 3: < 80 g/L; transfusion indicated; grade 4:Life-threatening consequences; urgent intervention indicated; grade 5: Death

    Measured: 1 years

Secondary outcomes (2)

  1. Nausea

    grade 3: Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated

    Measured: 1 years

  2. Vomiting

    grade 3: > 6 episodes (separated by 5 minutes) in 24 hrs; tube feeding, TPN, or hospitalization indicated; grade 4:Life-threatening consequences; urgent intervention indicated; grade 5: Death.

    Measured: 1 years

Timeline

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

  1. First posted15 Jun 2017
  2. Study start22 Jun 2016
  3. Primary completion12 Dec 2017
  4. Study completion20 Mar 2018

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
Randomised
Intervention model
Sequential
Model description
The initial dose was 25mg/m2 on d1,d22,d43 for 1 cycles; if no obvious toxicity was observed,follow 30mg/m2,35mg/m2,40mg/m2,45mg/m2, and 50mg/m2 gradients into the next dose group until the maximum tolerated dose or 50mg/m2
Masking
Single blind
Who is masked
Investigator
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03188497
Sponsor's protocol ID
zsu20170203
Status last verified
Apr 2018
First submitted
22 May 2017
Last updated
10 Apr 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang SY, Xu XW, Yao JJ, Peng PJ, Zhou B, Liu QD, Huang XP, Lin Z. Dose Escalation of Lobaplatin Concurrent with IMRT for the Treatment of Stage III-IVb NPC: A Phase I Clinical Trial. Transl Oncol. 2018 Aug;11(4):1007-1011. doi: 10.1016/j.tranon.2018.06.004. Epub 2018 Jun 29.

    PubMed 29966863

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lobaplatin and linear accelerator in people with Acute Toxic Effects and Tumor Responses, 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 9 inclusion and 8 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 10 Apr 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 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?

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?

Platelets (time frame: 1 years). The study lists 4 primary outcomes in all. 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 NCT03188497, which also lists 1 linked publication.

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 Apr 2018.

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