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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2022-01-13

Brief Summary

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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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Detailed Description

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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.

Conditions

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Squamous Cell Carcinoma of the Hypopharynx Stage III 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 Oropharynx Stage III Squamous Cell Carcinoma of the Oropharynx Stage IV Squamous Cell Carcinoma of the Oral Cavity Stage III Squamous Cell Carcinoma of the Oral Cavity Stage IV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Patients receive 3 cycles (cycle duration 21 days) of docetaxel (75mg/m²), cisplatin (75mg/m²) and 5-fluorouracil (750mg/m²) followed by Cetuximab (weekly, starting with 400mg/m² then continuing with 250 mg/m²) with radiotherapy (concomitant boost for 6 weeks).

Active comparator is 5-fluorouracil for first three cycles.

Group Type ACTIVE_COMPARATOR

Docetaxel

Intervention Type DRUG

75 mg/m² on day 1 of 21-days cycle

Cisplatin

Intervention Type DRUG

75 mg/m² on day 1 of 21-days cycle

5-fluorouracil

Intervention Type DRUG

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

Cetuximab Radioimmunotherapy

Intervention Type BIOLOGICAL

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

Boost irradiation

Intervention Type 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

B

All patients receive 3 cycles (cycle duration 21 days) of docetaxel (75mg/m²), cisplatin (75mg/m²) Cetuximab (weekly, starting with 400mg/m² and continuing with 250 mg/m²), followed by Cetuximab (weekly 250 mg/m²) with radiotherapy (concomitant boost for 6 weeks).

Experimental: cetuximab for the first three cycles.

Group Type EXPERIMENTAL

Docetaxel

Intervention Type DRUG

75 mg/m² on day 1 of 21-days cycle

Cisplatin

Intervention Type DRUG

75 mg/m² on day 1 of 21-days cycle

Cetuximab Induction

Intervention Type BIOLOGICAL

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

Cetuximab Radioimmunotherapy

Intervention Type BIOLOGICAL

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

Boost irradiation

Intervention Type 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

Interventions

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Docetaxel

75 mg/m² on day 1 of 21-days cycle

Intervention Type DRUG

Cisplatin

75 mg/m² on day 1 of 21-days cycle

Intervention Type DRUG

5-fluorouracil

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

Intervention Type DRUG

Cetuximab Induction

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

Intervention Type BIOLOGICAL

Cetuximab Radioimmunotherapy

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

Intervention Type BIOLOGICAL

Boost irradiation

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

Intervention Type RADIATION

Other Intervention Names

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Erbitux Erbitux Concomitant boost-irradiation

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No