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Nasopharyngeal CancersPhase 3NPC2006NCT00828386

Induction Chemotherapy and Chemoradiotherapy in Nasopharyngeal Cancers

A Phase 3 study testing Induction chemotherapy + concurrent radiochemotherapy vs. concurrent radiochemotherapy in people with Nasopharyngeal Cancers, run by Groupe Oncologie Radiotherapie Tete et Cou at 5 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a randomized, multicenter, phase III trial comparing induction chemotherapy with Docetaxel, Cisplatin and 5-Fluorouracil (TPF) followed by concurrent chemoradiotherapy to concurrent chemoradiotherapy alone, in nasopharyngeal cancers staged as T2b, T3, T4 and/or with lymph node involvement (≥ N1. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Nasopharyngeal Cancers
What is being tested?
Induction chemotherapy + concurrent radiochemotherapy vs. concurrent radiochemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
5 sitesin 4 countries
Study dates
Jan 2009to 19 Apr 2017
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • WHO II-III carcinoma of the nasopharynx, histologically proven by a nasal cavity biopsy, locally advanced T2b, T3, T4 and/or N1, N2 or N3 (UICC/AJCC2002).
  • Absence of distant metastases, confirmed by a chest CT scan, abdominal ultrasound (or CT scan) in case of abnormal hepatic function, and bone scintigraphy required.
  • Total absence of previous chemotherapy or radiotherapy, for whatever reason.
  • Total absence of surgical procedures for nasopharyngeal carcinoma.
  • Total absence of concurrent cancer treatment.
  • Total absence of chronic treatment (>= 3 months) with corticosteroids with a daily dosage >= 20 mg/day of methylprednisolone or equivalent.
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  • Age between 18 and 70 years.
  • Performance status 0 or 1 according to the WHO criteria.
  • Hematological function parameters performed within 10 days before inclusion:
  • Neutrophils >= 1.5 * 109/l
  • Platelets: >= 100 * 109/l
  • Hemoglobin: >= 10 g/dl
  • Hepatic function parameters performed within 10 days before inclusion:
  • Total bilirubin is normal
  • AST (SGOT) and ALT (SGPT) <= 2.5 * upper limit of normal (ULN) of each center.
  • Alkaline phosphatase <= 2.5 * ULN.
  • Renal function parameters performed within 10 days before inclusion: Creatinine clearance must be <= 55 ml/min.
  • Patient who has given his/her written consent before any specific procedure of the protocol.
  • Patient having a Social Security (social policy-holders)

Who cannot join

  • WHO I carcinoma of the nasopharynx, histologically proven by a nasal cavity biopsy.
  • Other previous or concomitant cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma.
  • Histological diagnosis on a lymph node biopsy.
  • Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures.
  • Symptomatic peripheral neuropathy with grade >= 2 according to the NCI-CTC criteria.
  • Other serious concurrent medical disease (non-exhaustive list):
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  • Unstable heart disease despite treatment.
  • Myocardial infarction within 6 months before inclusion in the trial.
  • A history of neurological or psychiatric events such as dementia, convulsions.
  • Severe uncontrolled infection.
  • Active gastroduodenal ulcer.
  • Obstructive Pulmonary Disease requiring hospitalization within the year prior to inclusion.
  • Clinical impairment of auditory function.
  • The presence, at time of screening, of psychological, familial, social or geographical factors that may have an effect on the compliance of the patient with the study protocol and monitoring comprises an exclusion criterion. These factors must be discussed with the patient before his or her inclusion in the trial.
  • Hypersensitivity to the excipients.
  • A patient already enrolled in another therapeutic trial on an investigational compound.
  • A person deprived of liberty or in the care of a guardian.
  • -

Trial locations and contacts

5 sites in 4 countries.

5 sites in 4 countries

France2 sites

  • Hôpital de la Pitié-Salpétrière

    Paris, 75013

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Morocco1 site

  • University of Casablanca

    Casablanca

Other trials in Morocco

Romania1 site

  • University of Cluj

    Cluj-Napoca

Other trials in Romania

Tunisia1 site

  • Hôpital Habib Bourguiba

    Sfax

Other trials in Tunisia

About this study

Official title: A Randomized, Multicenter, Phase III Trial Comparing Induction CT With Docetaxel, Cisplatin and 5-FU (TPF) Followed by Concurrent CT-RT to Concurrent CT Alone, in Nasopharyngeal Cancers Staged as T2b, T3, T4 and/or With Lymph Node Involvement (>N1)

This is a randomized, multicenter, phase III trial comparing induction chemotherapy with Docetaxel, Cisplatin and 5-Fluorouracil (TPF) followed by concurrent chemoradiotherapy to concurrent chemoradiotherapy alone, in nasopharyngeal cancers staged as T2b, T3, T4 and/or with lymph node involvement (≥ N1. The main end point is the event free survival.

Read the detailed description

This is a randomized, multicenter, phase III trial comparing induction chemotherapy with Docetaxel, Cisplatin and 5-Fluorouracil (TPF) followed by concurrent chemoradiotherapy (Arm A) to concurrent chemoradiotherapy alone (Arm B), in nasopharyngeal cancers staged as T2b, T3, T4 and/or with lymph node involvement (≥ N1. The main end point is the event free survival.

The treatments are :

Arm A:

induction chemotherapy: Docetaxel (75 mg/m² administered on D1 of each course, every 3 weeks via one-hour IV infusion) + Cisplatin(75 mg/m² administered on D1 via one-hour infusion )+ 5-FU (750 mg/m²/d administered as a continuous infusion from D1 to D5. The cycles will be repeated every 3 weeks up to a total of 3 courses.

followed by chemoradiotherapy with Cisplatin (40 mg/m2 starting on D1 of the radiation therapy) during 7 weeks

Arm B: Chemoradiotherapy with Cisplatin alone (40 mg/m2 starting on D1 of the radiation therapy) during 7 weeks

Being tested
Induction chemotherapy + concurrent radiochemotherapy vs. concurrent radiochemotherapy
Keywords
Nasopharyngeal cancers, induction chemotherapy, radiochemotherapy
Medical subject headings
Nasopharyngeal Neoplasms

What participants receive

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

  • Induction chemotherapy + concurrent radiochemotherapy vs. concurrent radiochemotherapyProcedure or surgery

    Induction chemotherapy (Docetaxel, Cisplatin and 5-Fluorouracil) + concurrent radiochemotherapy

Study groups in NCT00828386
Study groupRoleWhat they receive
Induction chemotherapy + concurrent chemoradiotherapyExperimentalInduction chemotherapy (Docetaxel + Cisplatin + 5-FU): * Docetaxel 75 mg/m² administered on D1 of each course, every 3 weeks, via one-hour IV infusion * Cisplatin 75 mg/m² administered on D1 via one-hour infusion followed by * 5-Fluorouracil (as a continuous infusion): 750 mg/m²/d administered as a continuous infusion from D1 to D5. The cycles will be repeated every 3 weeks up to a total of 3 courses. Followed by concurrent chemoradiotherapy with Cisplatin : weekly Cisplatin 40 mg/m2 starting on D1 of the radiation therapy (70 Gy/7 weeks).
Receives: Procedure: Induction chemotherapy + concurrent radiochemotherapy vs. concurrent radiochemotherapy
Concurrent radiochemotherapy aloneActive comparatorConcurrent chemoradiotherapy with Cisplatin : weekly Cisplatin 40 mg/m2 starting on D1 of the radiation therapy (70 Gy/7 weeks).
Receives: Procedure: Induction chemotherapy + concurrent radiochemotherapy vs. concurrent radiochemotherapy

What is being measured

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

  1. Event free-survival

    Measured: 3 years

Secondary outcomes (6)

  1. Survival

    Measured: 3 years

  2. late and acute toxicity according to NCI-CTC and EORTC/RTOG criteria

    Measured: early and late

  3. Cumulative incidence of loco-regional progression

    Measured: 3 years

  4. Cumulative rate of metastasis

    Measured: 3 years

  5. Global response to chemo-radiotherapy

    Measured: 3 years

  6. Global response to induction chemotherapy

    Measured: after the induction chemotherapy of the last patient included

Timeline

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

  1. First posted23 Jan 2009 (estimated)
  2. Study startJan 2009
  3. Primary completion19 Apr 2017
  4. Study completion19 Apr 2017

Why it stopped: Low accrual

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
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00828386
Sponsor's protocol ID
GORTEC NPC2006
Acronym
NPC2006
Status last verified
Jan 2019
First submitted
22 Jan 2009
Last updated
18 Jan 2019
Results posted
No

Publications

  • Tao Y, Auperin A, Graff P, Lapeyre M, Gregoire V, Maingon P, Geoffrois L, Verrelle P, Calais G, Gery B, Martin L, Alfonsi M, Deprez P, Bardet E, Pignon T, Rives M, Sire C, Bourhis J. Very accelerated radiotherapy or concurrent chemoradiotherapy for N3 head and neck squamous cell carcinoma: Pooled analysis of two GORTEC randomized trials. Oral Oncol. 2017 Aug;71:61-66. doi: 10.1016/j.oraloncology.2017.06.002. Epub 2017 Jun 9.

    PubMed 28688693

  • Bourhis J, Sire C, Graff P, Gregoire V, Maingon P, Calais G, Gery B, Martin L, Alfonsi M, Desprez P, Pignon T, Bardet E, Rives M, Geoffrois L, Daly-Schveitzer N, Sen S, Tuchais C, Dupuis O, Guerif S, Lapeyre M, Favrel V, Hamoir M, Lusinchi A, Temam S, Pinna A, Tao YG, Blanchard P, Auperin A. Concomitant chemoradiotherapy versus acceleration of radiotherapy with or without concomitant chemotherapy in locally advanced head and neck carcinoma (GORTEC 99-02): an open-label phase 3 randomised trial. Lancet Oncol. 2012 Feb;13(2):145-53. doi: 10.1016/S1470-2045(11)70346-1. Epub 2012 Jan 18.

    PubMed 22261362

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Induction chemotherapy + concurrent radiochemotherapy vs. concurrent radiochemotherapy in people with Nasopharyngeal Cancers, run by Groupe Oncologie Radiotherapie Tete et Cou at 5 sites in 4 countries.

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 19 inclusion and 18 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: stopped early, as of the sponsor's last update on 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France, Morocco, Romania, Tunisia. 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?

The study was stopped early (reason given: Low accrual). 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?

Event free-survival (time frame: 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 NCT00828386, which also lists 2 linked publications.

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 18 Jan 2019; AzTrials last refreshed its copy on 8 Nov 2026.

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