InductionChemo-Radio-Antibody-Treatment

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

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2015-08-31

Brief Summary

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This is an open-label, randomized, Phase II-study to evaluate the efficacy of a standard-TPF induction chemotherapy (IC) and an alternative TPF induction chemotherapy followed by radio-antibody-therapy, in patients with unresectable LA-SCC of the HN region (oro-hypopharynx carcinoma, cancer of the oral cavity).

The primary objective of the study is to assess the feasibility of an experimental 'fractionated' TPF regimen compared to a current standard TPF regimen.

Composite endpoint of compliance and feasibility in terms of

* response (RECIST1.1) and
* hematological acute toxicity (CTCAE v.4.02)
* on time application of RAT following an experimental or standard TPF IC.

Secondary endpoints are

* Treatment intensity achieved
* Toxicity (according to CTCAE v.4.02)
* Response rates after completion of induction chemotherapy and after completion of entire protocol treatment (RECIST1.1)
* Survival (progression-free, metastasis-free, recurrence-free, overall) 1 year after randomisation
* Quality of life according to EORTC QoL C30 \& HN35

The study will be conducted at 5-6 investigational sites in Germany recruiting 90 patients in total. Eligible patients will have a diagnosis of histologically confirmed SSC of the HN. Patients will receive one of 2 different regimens of TPF IC followed by cetuximab together with radiotherapy (RAT) or a standard radiochemotherapy(RCT) regimen.

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Detailed Description

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Conditions

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Squamous Cell Carcinoma of the Head Squamous Cell Carcinoma of the Neck

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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TPF standard

TPF version 1 (standard)

1. Induction chemotherapy:

Docetaxel 75 mg/m2 d 1 Cis-platinum 75 mg/m2 d 1 5-FU 750 mg/m2/d c.i. d 1-4 every 21 days for 3 cycles
2. Antibody therapy with:

cetuximab loading dose of 400 mg/m2 1 week prior to RTX, and 250 mg/m2 weekly x 6 concurrent to RTX
3. RTX: HART (72 Gy), IMRT or 3D-conformal techniques

Group Type ACTIVE_COMPARATOR

TPF induction chemotherapy

Intervention Type DRUG

Docetaxel 75 mg/m2 d 1 Cis-platinum 75 mg/m2 d 1 5-FU 750 mg/m2/d c.i. d 1-4 Cetuximab loading dose of 400 mg/m2 1 week prior to RTX, and 250 mg/m2 weekly x 6 concurrent to RTX

TPF experimental

TPF version 2 (experimental)

1. Induction chemotherapy:

Docetaxel 40 mg/m2 d 1+8 Cis-platinum 40 mg/m2 d 1+8 5-FU 1500 mg/m2/24h c.i. d 1+8 every 21 day for 3 cycles
2. Antibody therapy with:

cetuximab loading dose of 400 mg/m2 1 week prior to RTX, and 250 mg/m2 weekly x 6 concurrent to RTX
3. RTX: HART (72 Gy), IMRT or 3D-conformal techniques

Group Type EXPERIMENTAL

TPF experimental

Intervention Type DRUG

Docetaxel 40 mg/m2 d 1+8 Cis-platinum 40 mg/m2 d 1+8 5-FU 1500 mg/m2/24h c.i. d 1+8 every 21 day for 3 cycles 2. Antibody therapy with: cetuximab loading dose of 400 mg/m2 1 week prior to RTX, and 250 mg/m2 weekly x 6 concurrent to RTX

Standard RCT

Standard RCT:

1. HART (72 Gy), IMRT or 3D-conformal techniques
2. with concurrent chemotherapy: Cis-platinum 30 mg/m2 once weekly d 1, 8, 15, 22, 29, 36 5-FU 600mg/m² /24h c.i. d 1-5

Group Type ACTIVE_COMPARATOR

Standard Radiochemotherapy (HART)

Intervention Type RADIATION

Hyperfractionated accelerated radiotherapy with concurrent Cisplatin and 5-Fluorouracil chemotherapy

Interventions

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TPF induction chemotherapy

Docetaxel 75 mg/m2 d 1 Cis-platinum 75 mg/m2 d 1 5-FU 750 mg/m2/d c.i. d 1-4 Cetuximab loading dose of 400 mg/m2 1 week prior to RTX, and 250 mg/m2 weekly x 6 concurrent to RTX

Intervention Type DRUG

TPF experimental

Docetaxel 40 mg/m2 d 1+8 Cis-platinum 40 mg/m2 d 1+8 5-FU 1500 mg/m2/24h c.i. d 1+8 every 21 day for 3 cycles 2. Antibody therapy with: cetuximab loading dose of 400 mg/m2 1 week prior to RTX, and 250 mg/m2 weekly x 6 concurrent to RTX

Intervention Type DRUG

Standard Radiochemotherapy (HART)

Hyperfractionated accelerated radiotherapy with concurrent Cisplatin and 5-Fluorouracil chemotherapy

Intervention Type RADIATION

Other Intervention Names

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Docetaxel (Taxotere) Cisplatin 5-Flurouracil Cetuximab (Erbitux) Docetaxel (Taxotere) Cisplatin 5-Flurouracil Certuximab Cis-platinum 5-FU

Eligibility Criteria

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Inclusion Criteria

* Histologically proven unresectable SCC of the oral cavity, oropharynx and hypopharynx (stage IVA \& IVB)
* Written and signed informed consent
* Karnofsky PS \> 70 %
* Age ≥ 18 years
* Curative treatment intent
* Adequate bone marrow, hepatic and renal functions as evidenced by the following:

Hematology (Bone marrow):

* Neutrophils \> 2.0 109/L
* Platelets \> 100 x 109/L
* Hemoglobin \> 10 g/dL

Hepatic function:

* Total serum bilirubin \< 1 time the UNL of the participating center
* ASAT (SGOT) and ALAT (SGPT) \< 2.5 x UNL
* Alkaline phosphatase \< 5 x UNL

Renal function :

* serum creatinine (SC) \< 120 µmol/L (1.4 mg/dl);
* if values are \> 120 µmol/L, the creatinine clearance should be \> 60 ml/min (actual or calculated by the Cockcroft-Gault method as follows :

weight (kg) x (140 - age) --------------------------------- K x serum creatinine

serum creatinine in mg/dL: K = 72 in man K = 85 in woman serum creatinine in µmol/L: K = 0.814 in man K = 0.96 in woman

• If of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post-dosing.

All patients require:

* dental examination and appropriate dental preservation if needed 1 week prior to the beginning of radiotherapy,
* gastric feeding tube and Portal-catheter.

Exclusion Criteria

* Other neoplasia within the past 5 years with the exception of a controlled skin cancer or "in situ" cervix cancer
* Unknown primary (CUP), nasopharynx, laryngeal or salivary gland cancer
* Distant metastatic disease (M1)
* Serious co-morbidity, e.g. arteriosclerosis with apoplexy, recent myocardial infarction, high-grade carotid stenoses, unstable cardiac disease despite treatment, congestive heart failure NYHA grade 3 and 4, insulin-dependent diabetes mellitus, uncontrolled hypertension, liver cirrhosis (Quick \< 75%, total protein \<3.0 g/dl, bilirubin \>2mg/ml) or kidney insufficiency (creatinine \>1.4 mg/ml, the creatinine clearance should be \> 60 ml/min)
* patients with ASAT or ALAT \> 2.5 UNL associated with alkaline phosphatase \> 5 UNL are not eligible for the study
* Known HIV-infection
* Pregnancy or lactation
* Women of child-bearing potential with unclear contraception
* Previous treatment of the disease with chemotherapy, radiotherapy, EGFR-targeting agents or surgery exceeding biopsy in head and neck
* Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study screening
* Social situations that limit compliance with study requirements
* Deficient dental preservation status or not accomplished wound healing
* Legal incapacity
* Prior accommodation in an institution under officially or judicially orders (§ 40 1 p. 3 No. 4 AMG)
* Symptomatic peripheral neuropathy National Cancer Institute-Common Toxicity Criteria (NCI-CTC) grade 2 and/or ototoxicity grade 2, except if due to trauma or mechanical impairment due to tumor mass
* Known allergic/hypersensitivity reaction to any of the components of the treatment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No