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Squamous Cell Carcinoma of the HeadPhase 2ICRATNCT01181401

InductionChemo-Radio-Antibody-Treatment

A Phase 2 study testing TPF induction chemotherapy, TPF experimental and Standard Radiochemotherapy (HART) in people with Squamous Cell Carcinoma of the Head and Squamous Cell Carcinoma of the Neck, run by Charite University, Berlin, Germany at 5 sites in Germany.

Completed

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

Official record
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Trial summary

This is an open-label, randomized, Phase II-study to evaluate the efficacy of a standard-TPF induction chemotherapy (IC) and an alternative TPF induction chemotherapy followed by radio-antibody-therapy, in patients with unresectable LA-SCC of the HN region (oro-hypopharynx carcinoma, cancer of the oral cavity). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TPF induction chemotherapy, TPF experimental and Standard Radiochemotherapy (HART)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
5 sitesGermany
Study dates
Aug 2010to Aug 2015
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven unresectable SCC of the oral cavity, oropharynx and hypopharynx (stage IVA \& IVB)
  • Written and signed informed consent
  • Karnofsky PS > 70 %
  • Age ≥ 18 years
  • Curative treatment intent
  • Adequate bone marrow, hepatic and renal functions as evidenced by the following:
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  • Hematology (Bone marrow):
  • Neutrophils > 2.0 109/L
  • Platelets > 100 x 109/L
  • Hemoglobin > 10 g/dL
  • Hepatic function:
  • Total serum bilirubin < 1 time the UNL of the participating center
  • ASAT (SGOT) and ALAT (SGPT) < 2.5 x UNL
  • Alkaline phosphatase < 5 x UNL
  • Renal function :
  • serum creatinine (SC) < 120 µmol/L (1.4 mg/dl);
  • if values are > 120 µmol/L, the creatinine clearance should be > 60 ml/min (actual or calculated by the Cockcroft-Gault method as follows :
  • weight (kg) x (140 - age) --------------------------------- K x serum creatinine
  • serum creatinine in mg/dL: K = 72 in man K = 85 in woman serum creatinine in µmol/L: K = 0.814 in man K = 0.96 in woman
  • If of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post-dosing.
  • All patients require:
  • dental examination and appropriate dental preservation if needed 1 week prior to the beginning of radiotherapy,
  • gastric feeding tube and Portal-catheter.

Who cannot join

  • Other neoplasia within the past 5 years with the exception of a controlled skin cancer or "in situ" cervix cancer
  • Unknown primary (CUP), nasopharynx, laryngeal or salivary gland cancer
  • Distant metastatic disease (M1)
  • Serious co-morbidity, e.g. arteriosclerosis with apoplexy, recent myocardial infarction, high-grade carotid stenoses, unstable cardiac disease despite treatment, congestive heart failure NYHA grade 3 and 4, insulin-dependent diabetes mellitus, uncontrolled hypertension, liver cirrhosis (Quick < 75%, total protein <3.0 g/dl, bilirubin >2mg/ml) or kidney insufficiency (creatinine >1.4 mg/ml, the creatinine clearance should be > 60 ml/min)
  • patients with ASAT or ALAT > 2.5 UNL associated with alkaline phosphatase > 5 UNL are not eligible for the study
  • Known HIV-infection
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  • Pregnancy or lactation
  • Women of child-bearing potential with unclear contraception
  • Previous treatment of the disease with chemotherapy, radiotherapy, EGFR-targeting agents or surgery exceeding biopsy in head and neck
  • Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study screening
  • Social situations that limit compliance with study requirements
  • Deficient dental preservation status or not accomplished wound healing
  • Legal incapacity
  • Prior accommodation in an institution under officially or judicially orders (§ 40 1 p. 3 No. 4 AMG)
  • Symptomatic peripheral neuropathy National Cancer Institute-Common Toxicity Criteria (NCI-CTC) grade 2 and/or ototoxicity grade 2, except if due to trauma or mechanical impairment due to tumor mass
  • Known allergic/hypersensitivity reaction to any of the components of the treatment

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites

  • Charité Universitaetsmedizin Berlin, CVK, CBF

    Berlin, 13353

  • University Medical Center Hamburg - Eppendorf

    Hamburg, 20246

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitätsklinikum Gießen und Marburg

    Marburg, 35043

  • Universitätsklinikum Regensburg

    Regensburg, 93053

Other trials in Germany

About this study

Official title: Randomized Phase II Study of Two Different Regimens of TPF Induction Chemotherapy Regimen Followed by Radiation Therapy Plus Cetuximab (TPF-CET-HART) vs. HART and Cis-platinum, 5-FU (PF-HART) in Patients With Locally Advanced Unresectable Squamous Cell Carcinomas of the Head and Neck

This is an open-label, randomized, Phase II-study to evaluate the efficacy of a standard-TPF induction chemotherapy (IC) and an alternative TPF induction chemotherapy followed by radio-antibody-therapy, in patients with unresectable LA-SCC of the HN region (oro-hypopharynx carcinoma, cancer of the oral cavity).

The primary objective of the study is to assess the feasibility of an experimental 'fractionated' TPF regimen compared to a current standard TPF regimen.

Read more

Composite endpoint of compliance and feasibility in terms of

  • response (RECIST1.1) and
  • hematological acute toxicity (CTCAE v.4.02)
  • on time application of RAT following an experimental or standard TPF IC.

Secondary endpoints are

  • Treatment intensity achieved
  • Toxicity (according to CTCAE v.4.02)
  • Response rates after completion of induction chemotherapy and after completion of entire protocol treatment (RECIST1.1)
  • Survival (progression-free, metastasis-free, recurrence-free, overall) 1 year after randomisation
  • Quality of life according to EORTC QoL C30 \& HN35

The study will be conducted at 5-6 investigational sites in Germany recruiting 90 patients in total. Eligible patients will have a diagnosis of histologically confirmed SSC of the HN. Patients will receive one of 2 different regimens of TPF IC followed by cetuximab together with radiotherapy (RAT) or a standard radiochemotherapy(RCT) regimen.

Being tested
TPF induction chemotherapy, TPF experimental, Standard Radiochemotherapy (HART)
Keywords
induction chemotherapy, radiotherapy, locally advanced head neck tumor, toxicity, LA SCCHN, Unresectable squamous cell cancer of the head and neck,, Stage IV (UICC)

What participants receive

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

  • TPF induction chemotherapyDrug

    Also called Docetaxel (Taxotere), Cisplatin, 5-Flurouracil, Cetuximab (Erbitux)

    Docetaxel 75 mg/m2 d 1 Cis-platinum 75 mg/m2 d 1 5-FU 750 mg/m2/d c.i. d 1-4 Cetuximab loading dose of 400 mg/m2 1 week prior to RTX, and 250 mg/m2 weekly x 6 concurrent to RTX

  • TPF experimentalDrug

    Also called Docetaxel (Taxotere), Cisplatin, 5-Flurouracil, Certuximab

    Docetaxel 40 mg/m2 d 1+8 Cis-platinum 40 mg/m2 d 1+8 5-FU 1500 mg/m2/24h c.i. d 1+8 every 21 day for 3 cycles 2. Antibody therapy with: cetuximab loading dose of 400 mg/m2 1 week prior to RTX, and 250 mg/m2 weekly x 6 concurrent to RTX

  • Standard Radiochemotherapy (HART)Radiation

    Also called Cis-platinum, 5-FU

    Hyperfractionated accelerated radiotherapy with concurrent Cisplatin and 5-Fluorouracil chemotherapy

Study groups in NCT01181401
Study groupRoleWhat they receive
TPF standardActive comparatorTPF version 1 (standard) 1. Induction chemotherapy: Docetaxel 75 mg/m2 d 1 Cis-platinum 75 mg/m2 d 1 5-FU 750 mg/m2/d c.i. d 1-4 every 21 days for 3 cycles 2. Antibody therapy with: cetuximab loading dose of 400 mg/m2 1 week prior to RTX, and 250 mg/m2 weekly x 6 concurrent to RTX 3. RTX: HART (72 Gy), IMRT or 3D-conformal techniques
Receives: Drug: TPF induction chemotherapy
TPF experimentalExperimentalTPF version 2 (experimental) 1. Induction chemotherapy: Docetaxel 40 mg/m2 d 1+8 Cis-platinum 40 mg/m2 d 1+8 5-FU 1500 mg/m2/24h c.i. d 1+8 every 21 day for 3 cycles 2. Antibody therapy with: cetuximab loading dose of 400 mg/m2 1 week prior to RTX, and 250 mg/m2 weekly x 6 concurrent to RTX 3. RTX: HART (72 Gy), IMRT or 3D-conformal techniques
Receives: Drug: TPF experimental
Standard RCTActive comparatorStandard RCT: 1. HART (72 Gy), IMRT or 3D-conformal techniques 2. with concurrent chemotherapy: Cis-platinum 30 mg/m2 once weekly d 1, 8, 15, 22, 29, 36 5-FU 600mg/m² /24h c.i. d 1-5
Receives: Radiation: Standard Radiochemotherapy (HART)

What is being measured

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

  1. Feasibility of an experimental 'fractionated' TPF regimen compared to a current standard TPF regimen.

    acute hematological toxicity

    Measured: August 2010- December 2012

Secondary outcomes (1)

  1. Survival and late morbidity

    All adequate items illustrating acute toxicity and late morbidity, in particular by hematological measures until one year after treatment (according to NCI-CTCAE v.4.02) Survival (progression-free, metastases-free, recurrence-free, Overall survival) after 1 year Response rates after TPF IC (RECIST1.1) Response rates after completion of multimodal treatment (see follow-up for scheduling RECIST1.1) Efficacy in relation to HPV status (p16 IHC) Quality of life according to EORTC QLC-30 \& HN35

    Measured: 1 year

Timeline

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

  1. First posted13 Aug 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionApr 2015
  4. Study completionAug 2015

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
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01181401
Sponsor's protocol ID
EudraCT No. 2010-019347-18
Acronym
ICRAT
Status last verified
Jan 2019
First submitted
12 Aug 2010
Last updated
31 Jan 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Vermorken JB, Remenar E, van Herpen C, Gorlia T, Mesia R, Degardin M, Stewart JS, Jelic S, Betka J, Preiss JH, van den Weyngaert D, Awada A, Cupissol D, Kienzer HR, Rey A, Desaunois I, Bernier J, Lefebvre JL; EORTC 24971/TAX 323 Study Group. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1695-704. doi: 10.1056/NEJMoa071028.

    PubMed 17960012

  • Posner MR, Hershock DM, Blajman CR, Mickiewicz E, Winquist E, Gorbounova V, Tjulandin S, Shin DM, Cullen K, Ervin TJ, Murphy BA, Raez LE, Cohen RB, Spaulding M, Tishler RB, Roth B, Viroglio Rdel C, Venkatesan V, Romanov I, Agarwala S, Harter KW, Dugan M, Cmelak A, Markoe AM, Read PW, Steinbrenner L, Colevas AD, Norris CM Jr, Haddad RI; TAX 324 Study Group. Cisplatin and fluorouracil alone or with docetaxel in head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1705-15. doi: 10.1056/NEJMoa070956.

    PubMed 17960013

  • Haddad R, Colevas AD, Tishler R, Busse P, Goguen L, Sullivan C, Norris CM, Lake-Willcutt B, Case MA, Costello R, Posner M. Docetaxel, cisplatin, and 5-fluorouracil-based induction chemotherapy in patients with locally advanced squamous cell carcinoma of the head and neck: the Dana Farber Cancer Institute experience. Cancer. 2003 Jan 15;97(2):412-8. doi: 10.1002/cncr.11063.

    PubMed 12518365

  • Bonner JA, Harari PM, Giralt J, Cohen RB, Jones CU, Sur RK, Raben D, Baselga J, Spencer SA, Zhu J, Youssoufian H, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a phase 3 randomised trial, and relation between cetuximab-induced rash and survival. Lancet Oncol. 2010 Jan;11(1):21-8. doi: 10.1016/S1470-2045(09)70311-0. Epub 2009 Nov 10.

    PubMed 19897418

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TPF induction chemotherapy, TPF experimental and Standard Radiochemotherapy (HART) in people with Squamous Cell Carcinoma of the Head and Squamous Cell Carcinoma of the Neck, run by Charite University, Berlin, Germany at 5 sites in Germany.

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 23 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 31 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 Germany. 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?

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?

Feasibility of an experimental 'fractionated' TPF regimen compared to a current standard TPF regimen. (time frame: August 2010- December 2012). 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 NCT01181401, which also lists 4 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 31 Jan 2019.

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