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Nasopharyngeal CarcinomaPhase 2NCT01614938

Induction Chemotherapy Followed by Concurrent Radiation With Cetuximab or Cisplatin in Locally Advanced Nasopharyngeal Cancer

A Phase 2 study testing Cetuximab, Cisplatin and Docetaxel in people with Nasopharyngeal Carcinoma, run by Fudan 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of this study is to compare the efficacy and toxicity of docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent radiotherapy with cetuximab or weekly cisplatin in locally advanced nasopharyngeal carcinoma. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
Cetuximab, Cisplatin and Docetaxel
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteChina
Study dates
Aug 2010to Aug 2014
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

  • Histopathologically proven nasopharyngeal carcinoma (WHO type 2 or 3)
  • Stage Ⅲ-ⅣB disease (AJCC/UICC 2009)
  • ECOG performance status of 0-1
  • Life expectancy of more than 6 months
  • Signed written informed consent
  • Adequate organ function including the following:
Show all 13Show fewer
  • Absolute neutrophil count (ANC) >= 1.5 * 109/l
  • Platelets count >= 100 * 109/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

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 or concomitant 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

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: Phase II Trial of Docetaxel-Cisplatin Neoadjuvant Chemotherapy Followed by Concurrent Radiotherapy With Cetuximab or Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma

The purpose of this study is to compare the efficacy and toxicity of docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent radiotherapy with cetuximab or weekly cisplatin in locally advanced nasopharyngeal carcinoma.

Read the detailed description

Although concurrent chemoradiation is the standard treatment modality for locally advanced nasopharyngeal carcinoma (NPC), high incidences of distant metastases and severe treatment related toxicities have become an obstacle to be overcome. A phase Ⅱ study conducted by Hui et al. showed that neoadjuvant docetaxel-cisplatin (TP) chemotherapy followed by concurrent chemoradiotherapy was superior to the standard concomitant chemoradiation in terms of the 3-year OS without significantly exacerbating the acute toxicities. Moreover, Bonner et al. demonstrated that RT with concurrent Cetuximab significantly improved the 5-year OS and did not increase the treatment induced toxicities when compared with RT alone. Therefore, we initiated this study to compare the efficacy and toxicity of the two regimens, neoadjuvant chemotherapy followed by concurrent radiotherapy with cetuximab or weekly cisplatin for locally advanced NPC.

Being tested
Cetuximab, Cisplatin, Docetaxel, Intensity-modulated radiotherapy
Keywords
Nasopharyngeal carcinoma, Locally advanced, Cetuximab, Weekly cisplatin chemotherapy, Intensity-modulated radiotherapy
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

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

  • CetuximabDrug

    Also called Erbitux

    400 mg/m2 initial dose before radiation, then 250 mg/m2 weekly during radiation

  • CisplatinDrug

    Also called Platinol

    2 cycles of induction chemotherapy every 3 weeks with cisplatin 80 mg/m2 D1-3

  • DocetaxelDrug

    Also called Taxotere

    2 cycles of induction chemotherapy every 3 weeks with docetaxel 75 mg/m2 D1

  • Intensity-modulated radiotherapyRadiation

    Also called IMRT

    a total dose of 66-70.4Gy in 30-32 fractions over 6-6.5 weeks planned to be delivered to the PTV of gross tumor

  • CisplatinDrug

    Also called Platinol

    2 cycles of induction chemotherapy every 3 weeks with cisplatin 80 mg/m2 D1-3, then 6 cycles of concomitant chemotherapy every week with cisplatin 30 mg/m2 D1

Study groups in NCT01614938
Study groupRoleWhat they receive
cisplatin-radiotherapy (CRT)Active comparatorThe arm receiving docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent weekly cisplatin and radiotherapy
Receives: Drug: Docetaxel; Radiation: Intensity-modulated radiotherapy; Drug: Cisplatin
cetuximab-radiotherapy (ERT)ExperimentalThe arm receiving docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent cetuximab and radiotherapy
Receives: Drug: Cetuximab; Drug: Cisplatin; Drug: Docetaxel; Radiation: Intensity-modulated radiotherapy

What is being measured

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

  1. Progression-free survival

    The time from date of randomization until date of first documented disease progression or death from any cause, assessed up to 3 years.

    Measured: up to 3 years

Secondary outcomes (8)

  1. Overall survival

    The time from date of randomization until date of death due to any cause, assessed up to 3 years.

    Measured: up to 3 years

  2. Locoregional recurrence-free survival

    The time from date of randomization until date of first documented disease recurrence at a locoregional site, assessed up to 3 years.

    Measured: up to 3 years

  3. Distant metastasis-free survival

    The time from date of randomization until date of first documented distant metastasis, assessed up to 3 years.

    Measured: up to 3 years

  4. Number of participants with hematologic toxicity events occurred during two cycles of neoadjuvant chemotherapy according to CTCAE v4.0

    Measured: 1, 2, 3 weeks post-dose

  5. Number of participants with acute toxicities (hematologic toxicity events, oral mucositis, acne-like rash) occurred during the concurrent treatment according to CTCAE v4.0

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

  6. Number of participants with late toxicities (hematologic toxicity events, dysphagia, acne-like rash) occurred from 3 months after completion of radiotherapy to last follow-up visit according to CTCAE v4.0

    Measured: Every 3 months during the first 2 years, then every 6 months during year 3 after completion of radiotherapy

  7. 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

  8. Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) at 3 months after completion of radiotherapy

    Measured: At 3 months after completion of radiotherapy

Timeline

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

  1. First posted8 Jun 2012 (estimated)
  2. Study startAug 2010
  3. Primary completionAug 2014 (estimated)
  4. Study completionAug 2014 (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
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01614938
Sponsor's protocol ID
HN201002
Status last verified
Jun 2012
First submitted
5 Jun 2012
Last updated
8 Jun 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Xu T, Liu Y, Dou S, Li F, Guan X, Zhu G. Weekly cetuximab concurrent with IMRT aggravated radiation-induced oral mucositis in locally advanced nasopharyngeal carcinoma: Results of a randomized phase II study. Oral Oncol. 2015 Sep;51(9):875-9. doi: 10.1016/j.oraloncology.2015.06.008. Epub 2015 Jul 7.

    PubMed 26163437

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cetuximab, Cisplatin and Docetaxel in people with Nasopharyngeal Carcinoma, run by Fudan 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 13 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: status not confirmed, as of the sponsor's last update on 8 Jun 2012. 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?

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?

Progression-free survival (time frame: up to 3 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 NCT01614938, 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 8 Jun 2012.

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