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Head-and-neck CancerPhase 2NCT02776137

Postoperative Concurrent Chemoradiotherapy With Docetaxel for High-Risk Squamous Cell Carcinoma of Head and Neck

A Phase 2 study testing Docetaxel and Intensity-modulated radiotherapy in people with Head-and-neck Cancer and Squamous Cell Carcinoma, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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

This is a non-randomized, phase II, open label study of postoperative concurrent chemoradiotherapy with docetaxel for high-risk squamous cell carcinoma of the head and neck(HNSCC).The primary purpose of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy with docetaxel in HNSCC patients. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Head-and-neck Cancer, Squamous Cell Carcinoma
What is being tested?
Docetaxel and Intensity-modulated radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
1 siteChina
Study dates
Mar 2016to Feb 2019
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

  • Histologically confirmed squamous cell carcinoma of the head and neck.Site of tumor origin in the oral cavity, oropharynx, larynx, or hypopharynx (excluding nasopharynx, or sinuses)
  • Gross total resection, with pathology demonstrating one or more of the following risk factors:
  • Histologic extracapsular nodal extension
  • Histologic involvement of ≥ 2 regional lymph nodes
  • Invasive cancer seen on microscopic evaluation of the resection margin, with no evidence of gross tumor residual
  • No evidence of distant metastases
Show all 17Show fewer
  • No synchronous or concurrent head and neck primary tumors
  • Karnofsky score over 60
  • Adequate organ function including the following:
  • Absolute neutrophil count (ANC) >= 1.5 * 10^9/l
  • Platelets count >= 100 * 10^9/l
  • Hemoglobin >= 10 g/dl
  • AST and ALT <= 2.5 times institutional upper limit of normal (ULN)
  • Total bilirubin <= 1.5 times institutional ULN
  • Creatinine clearance >= 50 ml/min
  • Serum creatine <= 1 times ULN
  • Signed written informed consent

Who cannot join

  • Evidence of distant metastasis
  • Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
  • Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
  • Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
  • Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai ninth people's hospital

    Shanghai, Shanghai Municipality, 200011

Other trials in China

About this study

Official title: Postoperative Concurrent Chemoradiotherapy With Docetaxel for High-Risk Squamous Cell Carcinoma of Head and Neck，A Non-Randomized Phase II Trial

This is a non-randomized, phase II, open label study of postoperative concurrent chemoradiotherapy with docetaxel for high-risk squamous cell carcinoma of the head and neck(HNSCC).The primary purpose of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy with docetaxel in HNSCC patients.

Being tested
Docetaxel, Intensity-modulated radiotherapy
Keywords
Docetaxel, Concurrent Chemoradiotherapy, High-Risk, Squamous Cell Carcinoma, Head-and-Neck Cancer
Medical subject headings
Head and Neck Neoplasms, Carcinoma, Squamous Cell

What participants receive

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

  • DocetaxelDrug

    Docetaxel: 20mg/m2/w for 6 weeks

  • Intensity-modulated radiotherapyRadiation

    Also called IMRT

    a total dose of 60Gy in 30 fractions over 6 weeks

Study groups in NCT02776137
Study groupRoleWhat they receive
Docetaxel GroupExperimentalConcurrent Chemoradiotherapy With Docetaxel
Receives: Drug: Docetaxel; Radiation: Intensity-modulated radiotherapy

What is being measured

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

  1. Disease-free survival

    from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years

    Measured: 2 years

Secondary outcomes (4)

  1. overall survival rate

    from date of enrollment until date of first death from any cause, assessed up to 2 years

    Measured: 2 years

  2. Acute toxicity profiles, graded according to the NCI CTCAE version 3.0

    Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v3.0 during the course of treatment

    Measured: up to 6-7 weeks

  3. Late toxicity profiles, graded according to the NCI CTCAE version 3.0

    Number of participants with treatment-related late toxicity as assessed every 3 months by CTCAE v3.0 up to 2 years

    Measured: up to 2 years

  4. Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) during the concurrent treatment

    QoL score will be documented on each weekend during the course of radiotherapy

    Measured: participants will be followed for the duration of hospital stay, an expected average of 6 weeks

Timeline

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

  1. First posted18 May 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionDec 2017
  4. Study completionFeb 2019

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
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02776137
Sponsor's protocol ID
2016HNRT001
Status last verified
Aug 2020
First submitted
11 May 2016
Last updated
19 Aug 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Li R, Jiang W, Dou S, Zhong L, Sun J, Zhang C, Zhu G. A Phase 2 Trial of Chemoradiation Therapy Using Weekly Docetaxel for High-Risk Postoperative Oral Squamous Cell Carcinoma Patients. Int J Radiat Oncol Biol Phys. 2020 Jul 1;107(3):462-468. doi: 10.1016/j.ijrobp.2020.02.464. Epub 2020 Feb 29.

    PubMed 32126267

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel and Intensity-modulated radiotherapy in people with Head-and-neck Cancer and Squamous Cell Carcinoma, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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 17 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: finished, as of the sponsor's last update on 19 Aug 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?

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?

Disease-free survival (time frame: 2 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 NCT02776137, 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 19 Aug 2020.

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