AzTrials
AzTrials

SCCHNPhase 2NCT01393184

Safety and Efficacy Study of Target Therapy Combined With Radiotherapy to Treat Senile Locally Advanced SCCHN

A Phase 2 study testing Nimotuzumab and Radiotherapy in people with SCCHN, run by Peking University.

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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

Radiotherapy alone is generally the only treatment in old patients with SCCHN. No evidence indicates combination with EGFR Target therapy can bring benefit for the patients. Senile Society is coming in China, the mean age in Beijing reaches 80 years old. Read more about this study

Who is it for?
Ages 65 to 85 years
Conditions the study is for
SCCHN
What is being tested?
Nimotuzumab and Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
No sites listed yet
Study dates
Mar 2011to Mar 2013
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 65 to 85 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Informed consent form
  • Age 65-85，both genders
  • HNSCC Confirmed by pathology
  • Primary site of oral cavity, oropharynx, hypopharynx, larynx
  • Stage Ⅲ/ⅣA,B
  • Primary lesions can be measured
Show all 11Show fewer
  • Karnofsky's Performance Scale ≥60
  • Life expectancy of more than 6 months
  • Haemoglobin≥100g/L ,WBC ≥3.5×109/L, platelet count≥90×109/L
  • Hepatic function: ALT、AST< 1.5 x ULN, TBIL< 1.5 x ULN
  • Renal function: Creatinine < 1.5 x ULN

Who cannot join

  • 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)
  • History of serious allergic or allergy
  • History of Serious lung or heart disease

About this study

Official title: Prospective, Randomized, Controlled, Phase II，Multiple Centered Clinical Trial of Nimotuzumab Combined With Radiotherapy for Senile Locally Advanced SCCHN

Radiotherapy alone is generally the only treatment in old patients with SCCHN. No evidence indicates combination with EGFR Target therapy can bring benefit for the patients. Senile Society is coming in China, the mean age in Beijing reaches 80 years old. A valuable treatment with efficacy and safety is needed for senile patient with SCCHN. The purpose of the study "Prospective, Randomized, Controlled, Phase II Multiple Centered Clinical Trial of Nimotuzumab Combined with Radiotherapy for Senile Locally Advanced SCCHN" was sponsored to evaluate the efficacy and safety for Nimotuzumab Combined with Radiotherapy in Senile SCCHN patients.

Read the detailed description

condition: Senile Locally Advanced SCCHN. Intervention: Drug:Nimotuzumab. Arm A: Radiotherapy+Nimotuzumab; Arm B: Radiotherapy alone. Phase: Phase 2

Conditions
SCCHN
Being tested
Nimotuzumab and Radiotherapy
Keywords
Target therapy

What participants receive

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

  • Nimotuzumab and RadiotherapyDrug

    Also called Nimotuzumab combined with radiotherapy

    Nimotuzumab (Nimo)： Nimotuzumab weekly Nimo (200 mg) × 8, started 1 w before RT

Study groups in NCT01393184
Study groupRoleWhat they receive
Radiotherapy + NimotuzumabExperimental1. Radiotherapy (RT) Technique: IMRT, Rapid Arc, Tomotherapy Total dose: GTV 70 Gy \& CTV 60 Gy/33F 2. Nimotuzumab (Nimo) weekly Nimo (200 mg) × 8, started 1 w before RT
Receives: Drug: Nimotuzumab and Radiotherapy
Radiotherapy (RT)Active comparatorRadiotherapy (RT) Technique: IMRT, Rapid Arc, Tomotherapy Total dose: GTV 70 Gy \& CTV 60 Gy/33F
Receives: Drug: Nimotuzumab and Radiotherapy

What is being measured

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

  1. Objective response rate: complete response + partial response on RECIST evaluation system

    Measured: 1-month after treatment

  2. Evaluate the Safety of Nimotuzumab Combined with Radiotherapy for old patients. Record the Number and Grade of Participants with Adverse Events as a Measure of Safety and Tolerability

    Measured: participants will be followed during the treatment,an expected average of 6 weeks

  3. Objective response rate: complete response + partial response on RECIST

    Measured: 3-months after treatment

Secondary outcomes (11)

  1. Evaluate the Local control Rate in 2 years.

    Measured: up to 2 years

  2. Evaluate the Quality of Life（QoL）of Senile Locally Advanced SCCHN treated by Nimotuzumab Combined with Radiotherapy or Radiotherapy alone.

    Record the subjective description of the patients by themself according to the QOL table.

    Measured: participants will be followed during the treatment,an expected average of 6 weeks

  3. Evaluate the overall survival of the patient in 2 years.

    Measured: up to 2 years

  4. Evaluate the progression free survival of the patient in 2 years.

    Measured: up to 2 years

  5. Evaluate the Quality of Life（QoL）of Senile Locally Advanced SCCHN treated by Nimotuzumab Combined with Radiotherapy or Radiotherapy alone.

    Record the subjective description of the patients by themself according to the QOL table.

    Measured: every 3 months after treatment

  6. Evaluate the Local control Rate in 3 years.

    Measured: up to 3 years

  7. Evaluate the Local control Rate in 5 years.

    Measured: up to 5 years

  8. Evaluate the overall survival of the patient in 3 years.

    Measured: up to 3 years

  9. Evaluate the overall survival of the patient in 5 years.

    Measured: up to 5 years

  10. Evaluate the progression free survival of the patient in 3 years.

    Measured: up to 3 years

  11. Evaluate the progression free survival of the patient in 5 years.

    Measured: 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 posted13 Jul 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionFeb 2013 (estimated)
  4. Study completionMar 2013 (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
92 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01393184
Sponsor's protocol ID
BT-IST-SCCHN-040
Status last verified
Mar 2011
First submitted
24 Jun 2011
Last updated
13 Jul 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nimotuzumab and Radiotherapy in people with SCCHN, run by Peking University.

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 11 inclusion and 6 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 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

Objective response rate: complete response + partial response on RECIST evaluation system (time frame: 1-month after treatment). The study lists 3 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 NCT01393184.

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 Jul 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in