NCT00774319

Brief 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). 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P75+ for phase_2 head-and-neck-cancer

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

April 11, 2012

Status Verified

April 1, 2012

Enrollment Period

3.3 years

First QC Date

October 16, 2008

Last Update Submit

April 10, 2012

Conditions

Head and Neck Cancer

Keywords

HNSCCneo AdjuvantChemoradiation therapyTPF

Outcome Measures

Primary Outcomes (1)

  • feasibility of both study-arms

    2 years

Secondary Outcomes (1)

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

    2 years

Study Arms (2)

1

ACTIVE COMPARATOR

Induction Chemotherapy with TPF Then: cisplatin 100 mg/m2 on day 1, 22 and 43 combined with conventional radiotherapy

Radiation: conventional radiotherapy with 'high' dose cisplatin

2

ACTIVE COMPARATOR

Induction chemotherapy with TPF Then cisplatin 40mg/m2 on day 1,8,15,22,29 and 35 combined with accelerated radiotherapy

Radiation: accelerated radiotherapy with 'low' dose cisplatin

Interventions

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

1
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

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Netherlands Cancer Institute

Amsterdam, Netherlands

RECRUITING

University Medical Center Nijmegen st Radboud

Nijmegen, 6525 GH, Netherlands

RECRUITING

Related Publications (2)

  • 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.

    PMID: 29230548DERIVED

  • 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.

    PMID: 26655558DERIVED

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • C.M.L. van Herpen, MD, Phd

    UMCN st Radboud

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

31 24 3610353c.vanherpen@onco.umcn.nl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2008

First Posted

October 17, 2008

Study Start

December 1, 2008

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

April 11, 2012

Record last verified: 2012-04

Locations

NL(2)