Clinical trial · Interventional
TPF Induction With Concomitant Chemoradiation to Treat Patients With Head and Neck Cancer
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).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| accelerated radiotherapy with 'low' dose cisplatin | Radiation | — | UNRESOLVED |
| conventional radiotherapy with 'high' dose cisplatin | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Induction Chemotherapy with TPF Then: cisplatin 100 mg/m2 on day 1, 22 and 43 combined with conventional radiotherapy
- interventionNames
- Radiation: conventional radiotherapy with 'high' dose cisplatin
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Induction chemotherapy with TPF Then cisplatin 40mg/m2 on day 1,8,15,22,29 and 35 combined with accelerated radiotherapy
- interventionNames
- Radiation: accelerated radiotherapy with 'low' dose cisplatin
Primary outcomes (1)
- measure
- feasibility of both study-arms
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 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. Exclusion Criteria: 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
References
Publications (2)
- DERIVEDDriessen 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 29230548
- DERIVEDDriessen 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 26655558