AzTrials
AzTrials

Head and Neck Squamous Cell CarcinomaPhase 3H&N07NCT01086826

Treatment of Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck

A Phase 3 study testing RT+CDDP/5-FU, RT+CETUXIMAB and INDUCTION CTx(TPF)+(RT+CDDP/5-FU) in people with Head and Neck Squamous Cell Carcinoma, run by Associazione Volontari Pazienti Oncologici at 60 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a randomized multicenter open label phase III factorial trial evaluating the 3 years OS in patients with locally advanced squamous cell carcinoma of head and neck treated with locoregional treatment (radiotherapy plus concomitant chemotherapy or cetuximab) with or without neoadjuvant chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
RT+CDDP/5-FU, RT+CETUXIMAB and INDUCTION CTx(TPF)+(RT+CDDP/5-FU)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
60 sitesItaly
Study dates
Mar 2008to Dec 2014
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically proven squamous cell carcinoma of the head and neck.
  • Primary tumor sites eligible : oral cavity, oropharynx, hypopharynx Although they are admittedly of squamous cell types, the following tumors will be excluded because of them responsiveness to chemotherapy: tumors of the nasal and paranasal cavities and of the nasopharynx.
  • Stage 3 or 4 disease without evidence of distant metastases verified by chest X Ray, abdominal ultrasound, or CT (liver function test abnormalities); bone scan in case of local symptoms.
  • At least one uni or bidimensionally measurable lesion.
  • Tumor considered inoperable after evaluation by a multidisciplinary team (i.e. a surgeon, a medical oncologist and a radiation oncologist). Criteria for inoperability are:
  • technical unresectability: tumor fixation/invasion to base of the skull or cervical vertebrae, involvement of the nasopharynx, and fixed lymph nodes.
Show all 19Show fewer
  • Physician decision based on low surgical curability. This category will include the following:
  • All T3-4 stages. ii) All N2-3 stages excluding T1 N2. iii) Patients for organ preservation. Reason for inoperability will be recorded in the CRF.
  • No previous chemotherapy or radiotherapy for any reason and no previous surgery for SCCHN (other than biopsy) are allowed at time of study entry.
  • Age > 18 years.
  • Karnofsky performance status > 70. (ECOG 0-1) (Appendix II)
  • No active alcohol addiction.
  • Life expectancy > 6 months.
  • Signed informed consent prior to beginning protocol specific procedures.
  • Adequate bone marrow, hepatic and renal functions as evidenced by the following:
  • Hematology (Bone marrow): i) Neutrophils > 2.0 109/L ii) Platelets > 100 x 109/L iii) Hemoglobin > 10 g/dL b) Hepatic function i) Total bilirubin < 1 x UNL ii) ASAT (SGOT) and ALAT (SGPT) < 2.5 x ULN iii) Alkaline phosphatase < 5 x ULN Patients with ASAT or ALAT > 1.5 x ULN associated with alkaline phosphatase > 2.5 x ULN are not eligible for the study.
  • Renal function : serum creatinine < 1 x UNL. In case of borderline value the creatinine clearance > 60 ml/min (calculated by the Cockcroft-Gault method as follows :
  • Patients must be available for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating center.
  • -

Who cannot join

  • Pregnant or lactating women or women of childbearing potential not using adequate contraception.
  • Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin, or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years. Any prior treatment with radiotherapy or chemotherapy is an exclusion criterion.
  • Symptomatic peripheral neuropathy > grade 2 by NCIC-CTG criteria
  • Symptomatic altered hearing > grade 2 by NCIC-CTG criteria.
  • Other serious illnesses or medical conditions including:
  • Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry.
Show all 16Show fewer
  • History of significant neurologic or psychiatric disorders including dementia or seizures.
  • Active uncontrolled infection.
  • Active peptic ulcer.
  • Hypercalcemia.
  • Chronic obstructive pulmonary disease requiring hospitalization during the year preceding study entry
  • History of hypersensitivity reaction to polysorbate 80 (Appendix IV)
  • Patients requiring intravenous alimentation.
  • Patients who experienced a weight loss of more than 20% of their body weight in the 3 months preceding study entry.
  • Concomitant treatment with any other anticancer therapy.
  • Participation in a therapeutic clinical trial within 30 days of study entry

Trial locations and contacts

60 sites in 1 country.

60 sites in 1 country

Italy60 sites

  • Istituto tumori "Giovanni Paolo II" IRCCS

    Bari, Bari, 70124

  • Ospedale S.Martino

    Belluno, Belluno, 32100

  • Ospedale Bellaria Di Bologna

    Bologna, Bologna, 40100

  • Policlinico S.Orsola-Malpighi

    Bologna, Bologna, 40138

  • Ospedale "S.Maurizio"

    Bolzano, Bolzano, 39100

  • Istituto Clinico S.Anna

    Brescia, Brescia, 25127

  • Azienda Ospedaliera Di Circolo

    Busto Arsizio, Varese, 21052

  • "Ospedale Businco"

    Cagliari, Cagliari, 09121

  • Policlinico Universitario

    Cagliari, Cagliari, 09121

  • Ospedale Di Camposampiero

    Camposampiero, Padova, 35012

  • Ospedale Civile di Castelfranco

    Castelfranco Veneto, Treviso, 31033

  • A.O Pugliese-Ciaccio

    Catanzaro, Catanzaro, 88100

  • Ospedale Clinicizzato Di Chieti

    Chieti, Chieti, 66100

  • Ospedale Civile di Cittadella

    Cittadella, Padova, 35010

  • Ospedale Santa Croce Di Fano

    Fano, Pesaro-urbino, 61032

  • Ospedale "S. Maria Del Prato"

    Feltre, Belluno, 32032

  • Ospedale "AUGUSTO MURRI"

    Fermo, Fermo, 63023

  • A.O.Universitaria

    Ferrara, Ferrara, 44100

  • Azienda Ospedaliera "S.Antonio Abate"

    Gallarate, Varese, 21013

  • Ospedale Civile di Latisana

    Latisana, Udine, 33057

  • Azienda Ospedaliera "Alessandro Manzoni"

    Lecco, Lecco, 23900

  • "AULSS 21 Mater Salutis"

    Legnago, Verona, 37045

  • P.O. SAN VINCENZO di Messina

    Messina, Messina, 98039

  • A.O. Universitaria Di Messina

    Messina, Messina, 98151

  • "Ospedale dell' Angelo"

    Mestre, Venezia, 30173

  • Irccs - Ospedale "S. Raffaele"

    Milan, Milano, 20132

  • "Istituto Europeo di Oncologia"

    Milan, Milano, 20141

  • "Ospedale San Paolo"

    Milan, Milano, 20143

  • A.O. Niguarda-Cà Granda

    Milan, Milano, 20162

  • "Ospedale Civile di Mirano"

    Mirano, Venezia, 30035

  • "A.O. - Policlinico Di Modena"

    Modena, Modena, 41100

  • H.S. Gerardo dei Tintori

    Monza, Moza-Brianza, 20052

  • "Istituto Oncologico Veneto"

    Padova, Padova, 35100

  • Policlinico Universitario di Palermo

    Palermo, Palermo, 90100

  • Casa di Cura "La Maddalena"

    Palermo, Palermo, 90121

  • A.O.Universitaria "Ospedale Maggiore"

    Parma, Parma, 43121

  • Osp. S. Maria della Misericordia

    Perugia, Perugia, 06132

  • A.O. "Ospedale S. Salvatore"

    Pesaro, Pesaro-urbino, 61100

  • Ospedale "G. Da Saliceto"

    Piacenza, Piacenza, 29121

  • Ospedale di Macerata

    Province of Macerata, Macerata, 62100

  • Osp. S. Maria Delle Croci

    Ravenna, Ravenna, 48100

  • A.O. "S.Camillo de' Lellis"

    Rieti, Rieti, 02100

  • Istituto Nazionale Tumori Regina Elena

    Roma, Roma, 00144

  • Ospedale S.Pietro "Fatebenefratelli"

    Roma, Roma, 00189

  • IRCCS Casa Sollievo della Sofferenza

    S. Giovanni Rotondo, Foggia, 71013

  • A.O. Ospedale Sant'Anna

    S.Fermo, Como, 22100

  • Ospedale "B.Eustachio" - S.Severino

    San Severino Marche, Macerata, 62027

  • Ospedale Civile Di Sondrio

    Sondrio, Sondrio, 23100

  • Osp. S.G. Moscati

    Taranto, Taranto, 74100

  • Ospedale "Boldrini"

    Thiene, Vicenza, 36015

  • P.O. "S.Antonio Abate"

    Tolmezzo, Udine, 33028

  • Ospedale "S. Chiara"

    Trento, Trento, 38100

  • Ospedale Di Treviglio - Caravaggio

    Treviglio, Bergamo, 24047

  • Ospedale Ca' Foncello

    Treviso, Treviso, 31100

  • "Ospedali Riuniti"

    Trieste, Trieste, 34100

  • A.O. Santa Maria della Misericordia

    Udine, Udine, 33100

  • Ospedale Di Circolo E Fondazione Macchi

    Varese, Varese, 21100

  • Ospedale Civile SS Giovanni e Paolo

    Venezia, Venezia, 30174

  • Ospedale Civile Maggiore Borgo Trento

    Verona, Verona, 37126

  • Ospedale civile di Vicenza

    Vicenza, Vicenza, 36100

Other trials in Italy

About this study

Official title: Neoadjuvant Docetaxel+Cisplatin and 5-fluorouracil (TPF) Followed by Radiotherapy+Concomitant Chemo or Cetuximab Versus Radiotherapy+Concomitant Chemo or Cetuximab in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck. A Randomized Phase III Factorial Study.

This is a randomized multicenter open label phase III factorial trial evaluating the 3 years OS in patients with locally advanced squamous cell carcinoma of head and neck treated with locoregional treatment (radiotherapy plus concomitant chemotherapy or cetuximab) with or without neoadjuvant chemotherapy.

Read the detailed description

This multicenter open label randomised phase III study is the implementation of a previous phase II randomized trial evaluating the efficacy of chemoradiotherapy with or without neoadjuvant TPF chemotherapy in locally advanced Head and Neck cancer. Assuming a randomisation ratio of 1:1, using the Mantel-Cox version of the log-rank test, 204 events are required in order to achieve a power of 0.80 of detecting an hazard ratio of 0.675 in favour of the experimental treatment with a type I error of 0.05, two-sided. With a uniform accrual of 4 years and a follow-up of 2 further years, the total number of required patients is 420 (210 per arm) to detect an absolute difference of 12% in 3 year overall survival in favour of the neoadjuvant arm (from 52.5% to 64.5%).Since the 101 patients randomized in the phase II part of the study will be included in the final analysis, 319 new patients are needed to complete the trial.The total number of 420 patients will be able to detect a difference of 10%, (from 35% to 45%) in terms of grade 3/4 in-field mucosal toxicity during the concomitant treatment (radiotherapy plus chemo or cetuximab) with a power of 80%. Within the H\&N07 trials was introduced a sub-study that allows to investigate the value of circulating marker evaluation as predictor of response to anti EGFR therapy in patients with cancer of the head and neck.

The expression level analysis of circulating biological markers will be evaluated on blood collected during therapy. The analysis will concern the following biological markers:Cytokines angiogenesis and cell adhesion molecules; Proteins involved in the EGFR signaling pathway (EGF, TGF-a, s-EGFR);circulating tumor cells (CTC) and circulating endothelial cells (CEC).

Being tested
RT+CDDP/5-FU, RT+CETUXIMAB, INDUCTION CTx(TPF)+(RT+CDDP/5-FU), INDUCTION CTx(TPF)+(RT+CETUXIMAB)
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

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

  • RT+CDDP/5-FUDrug

    Also called Radiotherapy, Cisplatin, 5-fluoruracil

    RT=70 Gy (2 Gy x1/day, 5 days per week for 7 weeks) CDDP: 20 mg/m2/day as 30 minutes IV infusion from day 1 to day 4 5-FU: 800 mg/m2/day for 4 days Both drugs will be administered during weeks 1 and 6 of irradiation, starting from day 1 of radiotherapy.

  • RT+CETUXIMABDrug

    Also called Radiotherapy, Cetuximab

    RT= 70 Gy (2 Gy x1/day, 5 days per week for 7 weeks) Cetuximab= 400 mg/m2 as first dose.Subsequent doses of 250 mg/ m2, weekly, for 7 times.

  • INDUCTION CTx(TPF)+(RT+CDDP/5-FU)Drug

    Also called Docetaxel. Cisplatin, 5-fluoruracil, Radiotherapy

    INDUCTION CTx(TPF):docetaxel 75 mg/m² + CDDP 80mg/m² + 5-FU 800 mg/m²/day from day 1 to day 4 will begin after the end of cisplatin infusion on day 1.Every 3 weeks.

    concomitant CTx= CDDP 20 mg/m2/day + 5-FU 800 mg/m2/day RT= 70 Gy(2 Gy x1/day, 5 days per week for 7 weeks)

  • INDUCTION CTx(TPF)+(RT+CETUXIMAB)Drug

    Also called Docetaxel. Cisplatin, 5-fluoruracil, Radiotherapy, Cetuximab

    INDUCTION CTx(TPF):docetaxel 75 mg/m² + CDDP 80mg/m² + 5-FU 800 mg/m²/day from day 1 to day 4 will begin after the end of cisplatin infusion on day 1.Every 3 weeks.

    RT= 70 Gy(2 Gy x1/day, 5 days per week for 7 weeks) CETUXIMAB= 400 mg/m2 as first dose. Subsequent doses of 250 mg/ m2, weekly, for 7 times.

Study groups in NCT01086826
Study groupRoleWhat they receive
RT+CDDP/5-FUActive comparatorRT: Tumor: 70 Gy (2 Gy x1/day, 5 days per week for 7 weeks) Lymph nodes: at least 50 Gy (2 Gy x1/day, 5 days per week for 6 weeks) CDDP: 20 mg/m2/day as 30 minutes IV infusion from day 1 to day 4 5-FU 800 mg/m2/day for 4 will be administered as continuos iv infusion Both drugs will be administered during weeks 1 and 6 of irradiation, starting from day 1 of radiotherapy.
Receives: Drug: RT+CDDP/5-FU
RT+CETUXIMABExperimentalRT: Tumor: 70 Gy (2 Gy x1/day, 5 days per week for 7 weeks) Lymph nodes: at least 50 Gy (2 Gy x1/day, 5 days per week for 6 weeks) CETUXIMAB: Cetuximab 400 mg/m2 as first dose, 7 days before the beginning of radiotherapy as 120 minutes IV infusion. Subsequent doses of 250 mg/ m2 will be administered as 60 minutes IV infusion, weekly, for 7 times.
Receives: Drug: RT+CETUXIMAB
INDUCTION CTx(TPF)+(RT+CDDP/5-FU)Active comparatorINDUCTION CTx(TPF): DOCETAXEL: 75 mg/m², 1 hour IV infusion, Day and every 3 weeks CISPLATIN: 80mg/m², intravenous infusion over 30-minute to 3 hours,Day 1 immediately after docetaxel administration and then every 3 weeks 5-FU 800 mg/m²/day, 24 hour continous infusion over 4 days, Day 1 after the end of cisplatin infusion, and every 3 weeks. RT: Tumor: 70 Gy (2 Gy x1/day, 5 days per week for 7 weeks) Lymph nodes: at least 50 Gy (2 Gy x1/day, 5 days per week for 6 weeks) CDDP: 20 mg/m2/day as 30 minutes IV infusion from day 1 to day 4 5-FU 800 mg/m2/day for 4 will be administered as continuos iv infusion
Receives: Drug: INDUCTION CTx(TPF)+(RT+CDDP/5-FU)
INDUCTION CTx(TPF)+(RT+CETUXIMAB)ExperimentalDOCETAXEL: 75 mg/m², 1 hour IV infusion, Day and every 3 weeks CISPLATIN: 80mg/m², intravenous infusion over 30-minute to 3 hours,Day 1 immediately after docetaxel administration and then every 3 weeks 5-FU 800 mg/m²/day, 24 hour continous infusion over 4 days, Day 1 after the end of cisplatin infusion, and every 3 weeks. RADIOTHRAPY: Tumor: 70 Gy (2 Gy x1/day, 5 days per week for 7 weeks) Lymph nodes: at least 50 Gy (2 Gy x1/day, 5 days per week for 6 weeks) CETUXIMAB: Cetuximab 400 mg/m2 as first dose, 7 days before the beginning of radiotherapy as 120 minutes IV infusion. Subsequent doses of 250 mg/ m2 will be administered as 60 minutes IV infusion, weekly, for 7 times.
Receives: Drug: INDUCTION CTx(TPF)+(RT+CETUXIMAB)

What is being measured

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

  1. overall survival

    overall survival defined as the time from the date of randomization to the date of death from any cause.

    Measured: 3 years

Secondary outcomes (1)

  1. progression free survival

    Secondary Objectives are: To compare the radiological and pathological complete response rate, the duration of response,the time to progression,the hematological and non-hematological toxicity,the duration of RTX plus concomitant CHT or cetuximab,the interruption number and the radiological complete response during concomitant chemoradiation and radiation plus cetuximab. To evaluate the biological profile expression,correlation between biological biomarkers expression,response to treatment and OS. To compare Quality of life.

    Measured: 3 years

Timeline

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

  1. First posted15 Mar 2010 (estimated)
  2. Study startMar 2008
  3. Primary completionApr 2014
  4. Study completionDec 2014

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
Factorial
Masking
None (open label)
Enrolment
320 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01086826
Sponsor's protocol ID
H&N07
Acronym
H&N07
Status last verified
Jun 2013
First submitted
12 Mar 2010
Last updated
26 Jan 2015
Results posted
No
Data monitoring committee
No

Publications

  • Ghi MG, Paccagnella A, Ferrari D, Foa P, Alterio D, Codeca C, Nole F, Verri E, Orecchia R, Morelli F, Parisi S, Mastromauro C, Mione CA, Rossetto C, Polsinelli M, Koussis H, Loreggian L, Bonetti A, Campostrini F, Azzarello G, D'Ambrosio C, Bertoni F, Casanova C, Emiliani E, Guaraldi M, Bunkheila F, Bidoli P, Niespolo RM, Gava A, Massa E, Frattegiani A, Valduga F, Pieri G, Cipani T, Da Corte D, Chiappa F, Rulli E; GSTTC (Gruppo di Studio Tumori della Testa e del Collo) Italian Study Group. Induction TPF followed by concomitant treatment versus concomitant treatment alone in locally advanced head and neck cancer. A phase II-III trial. Ann Oncol. 2017 Sep 1;28(9):2206-2212. doi: 10.1093/annonc/mdx299.

    PubMed 28911070

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RT+CDDP/5-FU, RT+CETUXIMAB and INDUCTION CTx(TPF)+(RT+CDDP/5-FU) in people with Head and Neck Squamous Cell Carcinoma, run by Associazione Volontari Pazienti Oncologici at 60 sites in Italy.

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 16 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 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in Italy. 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 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?

overall 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 NCT01086826, 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 26 Jan 2015.

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