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Oropharyngeal CancerPhase 2NCT01516996

Safety and Efficacy Study of Nimotuzumab Plus Neoadjuvant and Concurrent Chemoradiotherapy to Treat Oropharynx and Hypopharynx Cancer

A Phase 2 study testing docetaxel and cisplatin, IMRT and Nimotuzumab in people with Oropharyngeal Cancer and Hypopharyngeal Cancer, run by The Second People's Hospital of Sichuan at 13 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of this study is to evaluate the efficiency and safety of adding nimotuzumab to neoadjuvant and concurrent chemoradiotherapy in the treatment of patients with locoregionally advanced squamous cell carcinoma of the oropharynx and hypopharynx. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Oropharyngeal Cancer, Hypopharyngeal Cancer
What is being tested?
docetaxel and cisplatin, IMRT and Nimotuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
13 sitesChina
Study dates
Mar 2012to Mar 2018
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

  • Informed consent form
  • Histologically confirmed locally advanced (stages III and IVb), squamous cell carcinoma of the oropharynx and hypopharynx
  • The tumor mass had to be measurable
  • Karnofsky performance status ≥70
  • Life expectancy estimated than 6 months
  • Hematologic: WBC≥4×109 /L , plateletes≥100×109 /L, haemoglobin ≥100 g/L；
  • Hepatic: AST/ALT<1.5 times upper limit of normal (ULN)；serum bilirubin<1.5 times ULN;
  • Renal: Creatinine<1.5 times ULN；

Who cannot join

  • Known distant metastases
  • Primary tumor and nodes received surgery(except of biopsy)
  • Received other anti EGFR monoclonal antibody treatment
  • Previous chemotherapy or radiotherapy
  • Participation in other interventional clinical trials within 1 month
  • Other malignant tumor (except of non-melanoma skin Cancer or carcinoma in situ of cervix)
Show all 9Show fewer
  • History of serious allergic or allergy
  • History of Serious lung or heart disease
  • Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

China13 sites, 1 recruiting

  • Neimenggu Tumor Hospital

    Baotou, Neimenggu, 014030

    Active, not recruiting

  • The Second People's Hospital of Sichuan

    Chengdu, Sichuan, 610041

    Peng Xu, M.D., 15828312322, xupeng4618@163.com

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Active, not recruiting

  • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

    Chongqing, Sichuan, 400042

    Active, not recruiting

  • GuiZhou Cancer Hospital

    Guiyang, Guizhou, 550004

    Active, not recruiting

  • Yunnan Tumor Hospital, The Third Affiliated Hospital of KUNMING Medical University

    Kunming, Yunnan, 652100

    Active, not recruiting

  • Gansu Province Medical Science Institute

    Lanzhou, Gansu, 730050

    Active, not recruiting

  • Guangxi Tumor Hospital

    Nanning, Guangxi, 530021

    Active, not recruiting

  • Xinjiang tumor hospital, The Third Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000

    Active, not recruiting

  • Xijing Hospital

    Xi’an, Shanxi, 710032

    Active, not recruiting

  • ShanXi Cancer Hospital

    Xian, Shanxi, 710061

    Active, not recruiting

  • Qinghai Five Hospital

    Xining, Qinghai

    Active, not recruiting

  • The Tumor Affiliated Hospital of Ningxia Medical University General Hospita

    Yinchuan, Ningxia, 750004

    Active, not recruiting

Other trials in China

About this study

Official title: Neoadjuvant and Concurrent Chemoradiotherapy Plus Nimotuzumab in Treating Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Oropharynx and Hypopharynx

The purpose of this study is to evaluate the efficiency and safety of adding nimotuzumab to neoadjuvant and concurrent chemoradiotherapy in the treatment of patients with locoregionally advanced squamous cell carcinoma of the oropharynx and hypopharynx.

Read the detailed description

Locoregionally advanced squamous cell carcinoma of the head and neck(LA-SCCHN) poses one of the most complex management challenges. This stage of disease is still potentially curable, but requires combined-modality therapy. Recent studies have showed that induction chemotherapy（neoadjuvant）reduced the 3-year distant relapse rate. Concurrent chemoradiotherapy(CCRT), on the other hand, has demonstrated a significant and consistent benefit in local control rates, but its impact on distant failure is inconsistent. Nimotuzumab is a novel EGFR-targeting monoclonal antibody that has the potential.to be used as a single agent or as a radio- and chemotherapy sensitizer for the treatment of SCCHN. Thus, investigators conducted a randomized, multicenter phaseⅡ study to compare the efficiency and safety of adding nimotuzumab to neoadjuvant and CCRT with neoadjuvant and CCRT in the treatment of patients with locoregionally advanced squamous cell carcinoma of the oropharynx and hypopharynx.

Being tested
docetaxel and cisplatin, IMRT, Nimotuzumab
Keywords
Neoadjuvant, Concurrent Chemoradiotherapy,CCRT, Nimotuzumab, Locoregionally Advanced Oropharynx, Hypopharynx cancer, Randomized, Multicenter
Medical subject headings
Oropharyngeal Neoplasms, Hypopharyngeal Neoplasms

What participants receive

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

  • docetaxel and cisplatinDrug

    • The neoadjuvant consists of docetaxel 75mg/m2 day 1 and cisplatin 75mg/m2 days 1 to 3, repeat every 3 weeks, for 2 cycles.
    • CCRT: cisplatin 75mg/m2 is administered on day 1 of week 7,10 and 13 on current with RT

  • IMRTRadiation

    Also called CCRT

    IMRT is administered with chemotherapy from week 7 to week 13

    • GTV（primary tumor）：68-70Gy/35~38 F，once a day, 5 times per week
    • CTV（Clinical target）：56-66Gy/30~36f，once a day, 5 times per week
    • GTV-ln（positive neck region）：66-70Gy/33~36 F，once a day, 5 times per week
    • CTV-ln（negative neck region）：50-54Gy/28~30F, once a day, 5 times

  • NimotuzumabBiological

    Nimotuzumab was administered 200 mg IV over 1 hour on day 1,once a week, for 13~14 weeks

Study groups in NCT01516996
Study groupRoleWhat they receive
Neoadjuvant and CCRTActive comparatorNot described
Receives: Drug: docetaxel and cisplatin; Radiation: IMRT
Neoadjuvant and CCRT and NimotuzumabExperimentalNot described
Receives: Drug: docetaxel and cisplatin; Radiation: IMRT; Biological: Nimotuzumab

What is being measured

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

  1. Objective response rate

    Objective Response Rate: Complete response (CR)+ partial response (PR) rates base on RECIST evaluation system.

    Measured: 3 months after all the treatment ending

  2. The Number of Participants with Adverse Events

    Record the Number of participants with adverse events and the Grades of the AE according to CTCAE v3.0 as the two measure of safety.

    Measured: Participants will be followed during the treatment and 3 months after all the treatment ending ,an expected average of 26 weeks

Secondary outcomes (5)

  1. Overall Survival

    Measured: From date of randomization until the date of death from any cause,assessed up to 5 years

  2. Progression-Free Survival

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

  3. Evaluate the Local control Rate in 1 to 5 years.

    To evaluate each year until 5 years later

    Measured: Participants will be followed every year for the duration of 5 years

  4. Tumor-Free Survival

    Measured: From date of randomization until the date of first documented occurrence of primary, neck, distant relapse,assessed up to 5 years

  5. Non-metastatic Rate

    Measured: The time from randomization until distant relapse occur,assessed up to 5 years

Timeline

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

  1. First posted25 Jan 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionSep 2013 (estimated)
  4. Study completionMar 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01516996
Sponsor's protocol ID
BT-IST-SCCHN-036
Status last verified
Mar 2012
First submitted
11 Jan 2012
Last updated
20 Mar 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing docetaxel and cisplatin, IMRT and Nimotuzumab in people with Oropharyngeal Cancer and Hypopharyngeal Cancer, run by The Second People's Hospital of Sichuan at 13 sites 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 9 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 20 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: 3 months after all the treatment ending). The study lists 2 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 NCT01516996.

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 20 Mar 2012.

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