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Completed

NCT Number: NCT01884259

Induction Chemotherapy With TP+5-FU or TP+Cetuximab Followed by Radioimmuptherapy for Locally Advanced or Not Resectable SCCHNN

This multicentre, randomised Phase II Pilot Study evaluates the efficacy of docetaxel, cisplatin and 5-fluorouracil or Cetuximab, followed by Cetuximab with radiotherapy.

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Key information

Conditions

Squamous Cell Carcinoma of the Hypopharynx Stage III Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Laryngeal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Respiratory Tract Diseases Squamous Cell Carcinoma of Head and Neck Squamous Cell Carcinoma of the Hypopharynx Stage IV Squamous Cell Carcinoma of the Larynx Stage III Squamous Cell Carcinoma of the Larynx Stage IV Squamous Cell Carcinoma of the Oral Cavity Stage III Squamous Cell Carcinoma of the Oral Cavity Stage IV Squamous Cell Carcinoma of the Oropharynx Stage III Squamous Cell Carcinoma of the Oropharynx Stage IV

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Landeskrankenhaus Feldkirch, Feldkirch, Austria

Loading trial locations.

About this study

It will be evaluated whether 5-FU can be replaced by immunotherapy with cetuximab within a taxane/cisplatin-containing induction-chemotherapy scheme for advanced carcinoma of the head and neck. As 5-FU causes severe mucosal toxicities which are added to known toxicities of cisplatin, a combination-therapy with reduced toxicities and same efficacy would be a acceptable alternative to patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed local advanced squamous cell carcinoma of the Larynx, Hypopharynx, Oropharynx or Cavum oris stage III and IV
  • One measureable lesion (CT oder MR)
  • Age 18 - 75 (including)
  • Performance Score ECOG 0 - 1

Exclusion criteria

selected:

  • Distant metastases
  • ECOG Score >1
  • Prior radiation (Head and neck area)
  • Creatinin Clearance below 60 ml/µl
  • Acute infections
  • Neuropathy grade 3 or 4
  • Myocardial Infarction within the last 12 months
  • Acute coronary syndrome or othe clinically significant cardiovascular diseases

Treatment and study plan

docetaxel

Drug

75 mg/m² on day 1 of 21-days cycle

Cisplatin

Drug

75 mg/m² on day 1 of 21-days cycle

5-fluorouracil

Drug

750 mg/m² day 1 to 5 during 24 hours of 21-days cycle

Cetuximab Induction

Biological

weekly, starting with 400 mg/m² during 120 min.(saturation) then continuing with 250 mg/m²; duration 3 cycles with 21 days

Other names: Erbitux

Cetuximab Radioimmunotherapy

Biological

weekly, starting with 400 mg/m² during 120 min.(saturation only arm A) then continuing with 250 mg/m²; duration 7 weeks

Other names: Erbitux

Boost irradiation

Radiation

First 18 irradiations once daily with single dose of 1,8 Gy for 5 days per week. In addition by day 19 a second irradiation boost will be applied for further 12 days(1,5 Gy per day with at least 5 hours interval to 1,8 Gy dose. This results in total clinical target dose of 72 Gy and total subclinical target dose of 54 Gy. Duration of irradiation: 6 weeks

Other names: Concomitant boost-irradiation

Primary outcomes

  1. Response Rate (CR, PR)

    Time frame: 3 months after end of therapy

    RECIST criteria

Secondary outcomes

  1. Overall Response Rate (CR, PR, PD, SD)

    Time frame: until 3 months after therapy

    RECIST

  2. Locoregionally monitoring

    Time frame: after one year

  3. Progression Free Survival (PFS)

    Time frame: 1, 2 and 5 years after start of therapy

  4. Adverse reactions

    Time frame: During treatment and until 60 months after end of radiotherapy

    Information about acute toxicity (grade, relation to study drug) during study treatment and until 3 months after end of radiotherapy will be collected for each patient using CTCAE 3.0 criteria list.

    Information about late toxicity (grade) will be collected after 3 months of radiotherapy and until 60 months after radiotherapy using RTOG/EORTC toxicity criteria.

    Kind and number of toxicities will be described according to grade. The highest grade of each patient and toxicity will be analysed.

  5. Overall-Survival

    Time frame: 1, 2 and 5 years after start of therapy

Sponsors and collaborators

Lead sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Other

Registry information

Official study title

Randomised Phase II Pilot Study: Induction Chemotherapy With Docetaxel, Cisplatin and Cetuximab Versus Docetaxel, Cisplatin and 5 FU Followed by Radiotherapy With Cetuximab for Locally Advanced or Not Resectable Carcinoma of the Head and Neck

Acronym: HNO-2

Important dates

Study start
2013
Primary completion
2021
Study completion
2022
First posted
Jun 24, 2013
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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