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Nasopharyngeal CarcinomaPhase 2NCT04319471

Sufficient Chemotherapy Combine With Maintenance Chemotherapy in the Treatment of Oligometastatic Nasopharyngeal Carcinoma

A Phase 2 study testing Capecitabine/S-1, Chemotherapy and Head and neck radiotherapy in people with Nasopharyngeal Carcinoma, run by Fujian Cancer Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study is a randomized, phase II, prospective, multicenter clinical trial to evaluate the efficacy and safety of sufficient chemoradiotherapy plus oral capecitabine/S-1 for 1 year in the treatment of oligometastatic Nasopharyngeal Carcinoma Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
Capecitabine/S-1, Chemotherapy and Head and neck radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteChina
Study dates
1 Jun 2020to 1 Jun 2023
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with oligometastatic nasopharyngeal carcinoma (newly diagnosed or after treatment) ; patients with first diagnosis of nasopharyngeal carcinoma diagnosed by pathological biopsy; metastatic focus in principle need biopsy pathological diagnosis; but if the patient refuses to take the metastatic biopsy, the clinician decides with clinical evidence
  • Patients with a ECOG score of 0,1 or 2 and an expected survival period of more than 6 months; those who can cooperate in observing adverse reactions and outcomes;
  • At least one tumor lesion can be measured according to recist 1.1 criteria
  • Have good organ function
  • Informed consent signed and dated indicating that the patient has been informed of all relevant aspects of the study ;
  • Patients who are willing and able to comply with visiting arrangements, treatment plans, laboratory tests, and other research procedures ;
  • Be willing to comply with arrangements during the study to no longer participate in any other clinical studies related to drugs and medical devices.

Who cannot join

  • Patients with severe history of rapid-onset allergy to any of the drugs used in this study ;
  • Patients with local and/or regional recurrence;
  • Combine with other malignancies in 5 years (except non-melanin skin cancer or pre-invasion cervical cancer);
  • Any of the following conditions existed during the first six months of screening: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery transplantation, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism. patients known to have coronary artery disease, congestive heart failure that does not meet the above criteria or left ventricular ejection fraction < 50% and must use an optimized stable medical protocol determined by the therapist, if appropriate, to consult a cardiologist ;
  • Active infections, including tuberculosis, hepatitis b, hepatitis c, and human immunodeficiency virus. Patients with hbv surface antigen (hbsag) positive but HBV DNA <1000 copies/ml are eligible to participate in the study ;
  • Idiopathic pulmonary fibrosis, drug-induced pneumonia, organic pneumonia (bronchiolitis obliterans),Chest CT scans showing evidence of active pneumonia during history or screening of idiopathic pneumonia;
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  • Substance abuse or alcohol addiction
  • Inability or limitation of civil capacity ;
  • Patients with physical or mental disorders who, according to the researchers, can not fully or fully understand the possible complications of the study ;
  • May increase the risk associated with the treatment of the study protocol, or may interfere with the interpretation of the study results and (as judged by the researchers) may render the patient unfit to participate in other severe acute or chronic medical conditions (including immune colitis, inflammatory bowel disease, non-infectious pneumonia, pulmonary fibrosis) or mental disorders (including dementia and epilepsy, recent, past year or active suicidal ideation or behavior) or laboratory abnormalities ;
  • Patients with expected survival <6 months ;
  • Previous diagnosis of immunodeficiency or known Human Immunodeficiency Virus (HIV) or acquired immunodeficiency syndrome (aids)-related diseases ;
  • Male or female pregnant or lactating women who have fertility but are unwilling or unable to use contraception throughout the study period and at least one year after the treatment programme ;
  • Large amounts of glucocorticoids or other immunosuppression have been used within 4 weeks of treatmen

Trial locations and contacts

1 site in 1 country.

Shaojun Lin, DR contact

8613860603879

linshaojun@yeah.net

Qiaojuan Guo, DR contact

8615080013157

guoqiaojuan@163.com

China1 site

  • Department of radiation oncology, Fujian cancer hospital

    Fuzhou, Fujian, 350014

Other trials in China

About this study

Official title: Single Arm, Open, Multicenter Phase II Clinical Study of Sufficient Chemotherapy Combine With Maintenance Chemotherapy in the Treatment of Oligometastatic Nasopharyngeal Carcinoma

This study is a randomized, phase II, prospective, multicenter clinical trial to evaluate the efficacy and safety of sufficient chemoradiotherapy plus oral capecitabine/S-1 for 1 year in the treatment of oligometastatic Nasopharyngeal Carcinoma

Being tested
Capecitabine/S-1, Chemotherapy, Head and neck radiotherapy, Local Consolidative Therapy
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

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

  • Capecitabine/S-1Drug

    Also called Maintenance chemotherapy

    Drug: Capecitabine/S-1

  • ChemotherapyDrug

    Gemcitabine (1000mg/m2) D1 D8+ nidaplatinum (80-100mg/m2) D2 q3w ×4-6cycle

  • Head and neck radiotherapyRadiation

    IMRT is uesd for the synchronous oligometastatic Nasopharyngeal Carcinoma；

  • Local Consolidative TherapyOther

    radiotherapy，surgery or interventional therapy for all metastatic sites.

Study groups in NCT04319471
Study groupRoleWhat they receive
Sufficient Chemotherapy Combine With Maintenance ChemotherapyExperimentalPatients with oligometastatic Nasopharyngeal Carcinoma was given S-1 40-60mg bid d1-14, q4w, oral maintenance chemotherapy for 1 year or capecitabine 2500mg/m2/d twice daily oral d1-14, q4w after receiving sufficient chemotherapy and consolidative local therapy
Receives: Drug: Capecitabine/S-1; Drug: Chemotherapy; Radiation: Head and neck radiotherapy; Other: Local Consolidative Therapy

What is being measured

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

  1. Progression-Free Survival(PFS)

    PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.

    Measured: 12 months and 24 months

Secondary outcomes (1)

  1. overall survival(OS)

    OS was defined as the time from randomization to death from any cause

    Measured: 12 months and 24 months

Timeline

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

  1. First posted24 Mar 2020
  2. Study start1 Jun 2020 (estimated)
  3. Primary completion1 Jun 2023 (estimated)
  4. Study completion1 Jun 2023 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04319471
Sponsor's protocol ID
NPC003.1
Status last verified
Mar 2020
First submitted
22 Mar 2020
Last updated
24 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Capecitabine/S-1, Chemotherapy and Head and neck radiotherapy in people with Nasopharyngeal Carcinoma, run by Fujian 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 7 inclusion and 14 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 24 Mar 2020. 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 Shaojun Lin, DR (8613860603879, linshaojun@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival(PFS) (time frame: 12 months and 24 months). 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 NCT04319471.

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 24 Mar 2020.

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