AzTrials
AzTrials

Head and Neck CancerPhase 2CondorNCT00774319

TPF Induction With Concomitant Chemoradiation to Treat Patients With Head and Neck Cancer

A Phase 2 study testing conventional radiotherapy with 'high' dose cisplatin and accelerated radiotherapy with 'low' dose cisplatin in people with Head and Neck Cancer, run by Radboud University Medical Center at 2 sites in Netherlands.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of this trial is to compare two different treatments for fit patients with head and neck cancer: All patients are given induction-chemotherapy (docetaxel, cisplatin, 5-FU). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Head and Neck Cancer
What is being tested?
conventional radiotherapy with 'high' dose cisplatin and accelerated radiotherapy with 'low' dose cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
2 sitesNetherlands
Study dates
Dec 2008to Apr 2012
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histology and staging disease
  • Histologically or cytologically proven non-metastatic locally advanced HNSCC, stage III or IV, for which concomitant chemo-radiotherapy would be the standard therapy
  • Patients can be included either with irresectable disease or for which the concomitant chemoradiotherapy was chosen for organ preservation
  • Measurable disease
  • Primary site: oral cavity, oropharynx, hypopharynx and larynx
  • General conditions
Show all 13Show fewer
  • Written informed consent
  • Age >18 years and ≤ 65 years
  • WHO performance status 0-1
  • Adequate bone marrow function (WBC > 3.0 x 109/L, platelets > 100 x 109/L, Hb > 6 mmol/L)
  • Adequate hepatic function: total bilirubin < 1. 5 x upper normal limit, ASAT and ALAT < 2.5 x upper normal limits
  • Adequate renal function: calculated creatinin clearance > 60ml/min. (Cockcroft-Gault formula) Other
  • Expected adequacy of follow-up.

Who cannot join

  • General conditions
  • Active alcohol addiction
  • Admission for COPD in the last 12 months
  • Weight loss > 10% in 3 months before entry
  • Pregnancy or lactation
  • Patients (M/F) with reproductive potential not implementing adequate contraceptives measures
Show all 14Show fewer
  • Prior or current history
  • Prior surgery, radiotherapy or chemotherapy for this tumor
  • Serious concomitant diseases preventing the safe administration of chemotherapy and/or radiotherapy or likely to interfere with the study assessments
  • Serious active infections
  • Other malignancies in the past 5 years with the exception of adequately treated carcinoma in situ of the cervix, or squamous or basal cell carcinoma of the skin
  • Concomitant treatments
  • Concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation
  • Concurrent treatment with any other anti-cancer therapy

Trial locations and contacts

2 sites in 1 country.

C.M.L. van Herpen, Md, Phd contact

31 24 3610353

c.vanherpen@onco.umcn.nl

Netherlands2 sites, 2 recruiting

  • Netherlands Cancer Institute

    Amsterdam

    J.P. de Boer, 31 20 512 9111, j.d.boer@nki.nl

    J.P. de Boer

    Recruiting

  • University Medical Center Nijmegen st Radboud

    Nijmegen, 6525 GH

    C.M.L van Herpen, Md, Phd

    Recruiting

Other trials in Netherlands

About this study

Official title: A Randomised Study of TPF as Neoadjuvant Chemotherapy Followed by Concomitant Chemoradiotherapy (CRT) With Conventional Radiotherapy (RT) Versus Concomitant CRT With Accelerated RT in Patients With Locally Advanced Head and Neck Squamous Cell Cancer (HNSCC) in Good Condition. The Condor Study. A Study of the Dutch Head and Neck Cancer Group (DHNCG).

The purpose of this trial is to compare two different treatments for fit patients with head and neck cancer:

All patients are given induction-chemotherapy (docetaxel, cisplatin, 5-FU).

Subsequently patients are being randomised into two groups:

  • The first group receives neo-adjuvant chemotherapy ('high' dose cisplatin) and conventional radiotherapy
  • The second group receives neo-adjuvant chemotherapy ('low' dose cisplatin) and accelerated radiotherapy.
Read the detailed description

Induction Chemotherapy TPF(arm A and B)

: Docetaxel 75 mg/m2 iv on day 1, Cisplatin 75 mg/ m2 iv on day 1, 5-FU 750 mg/ m2/day iv continuous infusion (in Hickman or port a cath) on days 1-5; prophylactic G-CSF

This cycle will be repeated every 21 days for a maximum of 4 cycles. Clinical evaluation after each cycle and radiological evaluation after 2 cycles will take place. In case of PD or SD (after 2 cycles) with no minor response (no decrease in measurable disease from baseline) concomitant chemoradiotherapy will started per protocol.

Surgery The investigators in each centre can decide neck surgery for residual tumor

Being tested
conventional radiotherapy with 'high' dose cisplatin, accelerated radiotherapy with 'low' dose cisplatin
Keywords
HNSCC, neo Adjuvant, Chemoradiation therapy, TPF
Medical subject headings
Head and Neck Neoplasms, 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.

  • conventional radiotherapy with 'high' dose cisplatinRadiation

    radiotherapy: 5 fractions/week, total treatment time 7 weeks. Dose to gross tumor volume 70 Gy/35 fractions, dose to elective nodal areas 46 Gy/23 fractions.

    100 mg/m2 cisplatin iv on day 1, 22 and 43

  • accelerated radiotherapy with 'low' dose cisplatinRadiation

    Accelerated radiotherapy 6 fractions/week, total treatment time 6 weeks. During one of the weekdays two fractions will be delivered with an interval of at least 6h. Dose to gross tumor volume 70 Gy/35 fractions, dose to elective nodal areas 46 Gy/23 fractions cisplatin 40 mg/m2 iv on day 1,8,18,22,29,35

Study groups in NCT00774319
Study groupRoleWhat they receive
1Active comparatorInduction Chemotherapy with TPF Then: cisplatin 100 mg/m2 on day 1, 22 and 43 combined with conventional radiotherapy
Receives: Radiation: conventional radiotherapy with 'high' dose cisplatin
2Active comparatorInduction chemotherapy with TPF Then cisplatin 40mg/m2 on day 1,8,15,22,29 and 35 combined with accelerated radiotherapy
Receives: Radiation: accelerated radiotherapy with 'low' dose cisplatin

What is being measured

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

  1. feasibility of both study-arms

    Measured: 2 years

Secondary outcomes (1)

  1. to assess the toxicity profile, tumour response, disease free survival and overall survival in both study-arms. Also QoL will be measured.

    Measured: 2 years

Timeline

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

  1. First posted17 Oct 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionApr 2012 (estimated)
  4. Study completionApr 2012 (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
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00774319
Sponsor's protocol ID
NWHHT08-01
Acronym
Condor
Status last verified
Apr 2012
First submitted
16 Oct 2008
Last updated
11 Apr 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Driessen CML, Groenewoud JMM, de Boer JP, Gelderblom H, van der Graaf WTA, Prins JB, Kaanders JHAM, van Herpen CML. Quality of life of patients with locally advanced head and neck cancer treated with induction chemotherapy followed by cisplatin-containing chemoradiotherapy in the Dutch CONDOR study: a randomized controlled trial. Support Care Cancer. 2018 Apr;26(4):1233-1242. doi: 10.1007/s00520-017-3946-7. Epub 2017 Dec 11.

    PubMed 29230548

  • Driessen CM, de Boer JP, Gelderblom H, Rasch CR, de Jong MA, Verbist BM, Melchers WJ, Tesselaar ME, van der Graaf WT, Kaanders JH, van Herpen CM. Induction chemotherapy with docetaxel/cisplatin/5-fluorouracil followed by randomization to two cisplatin-based concomitant chemoradiotherapy schedules in patients with locally advanced head and neck cancer (CONDOR study) (Dutch Head and Neck Society 08-01): A randomized phase II study. Eur J Cancer. 2016 Jan;52:77-84. doi: 10.1016/j.ejca.2015.09.024. Epub 2015 Dec 1.

    PubMed 26655558

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing conventional radiotherapy with 'high' dose cisplatin and accelerated radiotherapy with 'low' dose cisplatin in people with Head and Neck Cancer, run by Radboud University Medical Center at 2 sites in Netherlands.

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 14 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 11 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. 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?

Contact C.M.L. van Herpen, Md, Phd (31 24 3610353, c.vanherpen@onco.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

feasibility of both study-arms (time frame: 2 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 NCT00774319, 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 11 Apr 2012.

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