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Salivary Gland CancerPhase 3NCT02048254

Study of I-125 Brachytherapy Versus Intensity-modulated Radiation Therapy to Treat Inoperable Salivary Gland Cancer

A Phase 3 study testing brachytherapy and IMRT in people with Salivary Gland Cancer, run by Peking 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 The sponsor has not verified this record for over two years, so it may be out of date.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

To compare the efficacy of Iodine-125 radioactive seeds implantation versus IMRT to treat inoperable salivary gland carcinoma. To compare the safety of Iodine-125 radioactive seeds implantation versus IMRT to treat inoperable salivary gland carcinoma. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Salivary Gland Cancer
What is being tested?
brachytherapy and IMRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
Feb 2014to Jun 2018
Phase
Phase 3
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients are diagnosed histologically as primary or recurrent salivary gland cancers that may occur in either major salivary glands or minor salivary glands.
  • The inoperable circumstance include: Primary or recurrent salivary gland cancers that could not be resected completely or could not get negative incision.
  • T3/T4 tumor patients with severe medical comorbidities could not accept the high risk of perioperative complications.
  • At least one measurable tumor or focus (according to RESIST 1.1 Standard).
  • Karnofsky score> 60.
  • Survival time predicted ≥ 3months;
  • HGB≥9 g/dL, WBC≥3.0×10^9/L, NEUT≥1.5×10^9/L, platelet count (PLT)≥ 100×10^9/L; TBIL≤1.5 upper limit of normal, Alanine aminotransferase (ALT)/AST≤3 upper limit of normal; Cera≤1.5 upper limit of normal.
  • Male or female with fertility in the experiment are willing to take contraceptive measures.

Who cannot join

  • Radioactive therapy history of head and neck.
  • Suffering from other malignant tumor in recent five years, except skin basal cell carcinoma or carcinoma in situs of cervix.
  • Chemotherapy history.
  • Receiving other effective therapy.
  • Distant metastases.
  • Pathologic result as squamous cell carcinoma.
Show all 13Show fewer
  • Neurological or mental abnormalities which affect cognitive ability.
  • Severe cardiovascular and cerebrovascular diseases, such as heart failure (NYHA III-IV class), uncontrolled coronary heart disease, cardiomyopathy, uncontrolled arrhythmias, uncontrolled hypertension, myocardial infarction or cerebral infarction within past six months.
  • Active serious clinical infections :> Class 2 NCI-Common Toxicity Criteria for Adverse Effects (CTCAE) Version 4.0 within 14 days before randomization, including active tuberculosis.
  • HIV infection or active hepatitis B or hepatitis C.
  • Uncontrolled systemic diseases, such as poorly controlled diabetes mellitus.
  • Medical history of interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or baseline chest X-ray / CT showed evidence of interstitial lung disease;
  • Pregnancy (via urine β-human chorionic gonadotropin test to determine) or breastfeeding.

Trial locations and contacts

1 site in 1 country.

Shuming Liu, Doctor contact

0086-13520162017

kqlsm@126.com

Yan Shi, Doctor contact

shiyan_sy@163.com

China1 site, 1 recruiting

  • Peking University, School and Hospital of Stomatology

    Beijing, Beijing Municipality, 100081

    Shuming Liu, Doctor, 13520162017, kqlsm@126.com

    Jianguo Zhang, Doctor, rszhang@126.com

    Recruiting

Other trials in China

About this study

Official title: A Randomized Control Trial (RCT) of Using Iodine-125 Brachytherapy Versus Intensity-modulated Radiation Therapy (IMRT) to Treat Inoperable Salivary Gland Cancer

  • To compare the efficacy of Iodine-125 radioactive seeds implantation versus IMRT to treat inoperable salivary gland carcinoma.
  • To compare the safety of Iodine-125 radioactive seeds implantation versus IMRT to treat inoperable salivary gland carcinoma.
Read the detailed description

The target population are those patients with inoperable salivary gland derived primary or recurrent cancer, including local advanced primary salivary gland cancer which could not be resected completely; recurrent salivary gland cancer which could not be resected completely; T3/T4 tumor which could not tolerate surgery due to severe combined disease. The subjects would be divided into Iodine-125 radioactive seeds permanent interstitial implantation brachytherapy and intensity-modulated radiation therapy randomly. During the follow-up period, the efficacy and the safety index would be monitored.

Being tested
brachytherapy, IMRT
Keywords
inoperable salivary gland cancer, brachytherapy, intensity-modulated radiation therapy
Medical subject headings
Salivary Gland Neoplasms

What participants receive

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

  • brachytherapyRadiation

  • IMRTRadiation

    Also called intensity-modulated radiation therapy

Study groups in NCT02048254
Study groupRoleWhat they receive
brachytherapyExperimentalIodine-125 radioactive seeds permanent interstitial implantation brachytherapy
Receives: Radiation: brachytherapy
IMRTActive comparatorIMRT (intensity-modulated radiation therapy), 6 Millivolt (MV)-x fractionated irradiation, 1 time/day, 5 times a week, till the end. Add up to 33 times.
Receives: Radiation: IMRT

What is being measured

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

  1. local control rate

    According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard, tumor progressing during the treatment and follow up period means local control failure, which include the sum of diameters of local and region target focus increases ≥20% or ≥5mm; new focus emerges at local or region area; metastases or secondary primary tumor would not be concluded.

    Measured: 1 year

Secondary outcomes (2)

  1. progression-free survival

    progression-free survival is definite as the time of death of tumor progression event emerges from the patient was randomize. According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard, tumor progressing during the treatment and follow up period means local control failure, which include the sum of diameters of local and region target focus increases ≥20% or ≥5mm; new focus emerges at local or region area; metastases or secondary primary tumor would not be concluded. No respondent means the tumor advances at the first day.

    Measured: 2 years

  2. overall survival

    Refers to the result from a random start time to death of any cause. Records from the beginning of the random time to time of any cause of death. Shedding of subjects censored cases recorded censored time.

    Measured: From date of randomization until the date of death from any cause, assessed up to 2 years

Timeline

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

  1. First posted29 Jan 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionDec 2017 (estimated)
  4. Study completionJun 2018 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02048254
Sponsor's protocol ID
PUCRP201308
Status last verified
Jun 2016
First submitted
23 Jan 2014
Last updated
13 Jun 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Liu SM, Wang HB, Sun Y, Shi Y, Zhang J, Huang MW, Zheng L, Lv XM, Zheng BM, Reilly KH, Yan XY, Ji P, Wu YF, Zhang JG. The efficacy of iodine-125 permanent brachytherapy versus intensity-modulated radiation for inoperable salivary gland malignancies: study protocol of a randomised controlled trial. BMC Cancer. 2016 Mar 7;16:193. doi: 10.1186/s12885-016-2248-7.

    PubMed 26951097

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing brachytherapy and IMRT in people with Salivary Gland Cancer, run by Peking 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 13 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 13 Jun 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Shuming Liu, Doctor (0086-13520162017, kqlsm@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

local control rate (time frame: 1 year). 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 NCT02048254, 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 13 Jun 2016.

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