Radiotherapy With Cisplatin Versus Radiotherapy With Cetuximab After Induction Chemotherapy for Larynx Preservation

Larynx Preservation With Induction Chemotherapy (Cisplatin, 5FU, Docetaxel) Followed by Radiotherapy Combined With Either Cisplatin or Cetuximab in Laryngopharyngeal Squamous Cell Carcinoma - A Randomised Phase II Study

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00169247

Enrollment

156

Registered

2005-09-15

Start date

2005-10-31

Completion date

Unknown

Last updated

2011-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypopharynx Cancer, Larynx Cancer

Keywords

larynx cancer, hypopharynx cancer, larynx preservation, concomitant radiochemotherapy, cisplatin, cetuximab, randomized trial

Brief summary

Larynx preservation remains a very challenging approach in patients with larynx/pharynx cancer. A first attempt consisted of induction chemotherapy followed in good responders by irradiation. This approach allowed to preserve 60 % of the larynx without any significant difference in survival. The second attempt consisted of concurrent chemo-irradiation. This approach provided a higher larynx preservation rate but survival remained unchanged and mucosal toxicity was also higher. A third approach is currently under evaluation: induction chemotherapy followed by concurrent chemo-irradiation in good responders.

Detailed description

At ASCO 2004 there were 3 major presentations issuing an increasing in survival: * the update of the MACH-NC meta-analysis showed that actually only concurrent chemo-irradiation trials found a significantly improved survival (in particular the addition of cisplatinum alone to radiotherapy) * the addition of docetaxel to the cisplatinum-5FU regimen (TPF) when compared with cisplatinum--5FU (PF) * the addition of cetuximab to irradiation On this basis we decided to carry-out a randomized phase II for previously untreated patients requiring a total laryngectomy: All patients after a complete work-up including a CTscan will receive 3 cycles of TPF(T: 75 mg/m², P: 75 mg/m² and 5FU 750 mg/m²). Patients with response over 50 % (endoscopy and CTscan) will be randomized to receive either irradiation (70 Gy) and cisplatinum (100 mg/m² on D1, D22 and D43) or irradiation (70 Gy) with cetuximab (loading dose of 400 mg followed by weekly 250 mg for a total of 8 cycles. Patients with less than 50% decease in tumour volume after TPF, patients with residual or recurrent disease after either RT-CDDP or RT-cetuximab will get salvage total laryngectomy.

Interventions

DRUGCisplatin

PROCEDURERadiotherapy 70 Gy, 35 fractions

DRUGcetuximab

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Larynx or hypopharynx squamous cell carcinoma proven by histology, locally advanced, only eligible for surgery as total or sub-total (pharyngo-)laryngectomy * Performance status 0-1 * Neutrophils \>=1.5 x 109/l, Platelets count \>=100 x 109/l, haemoglobin \>=10 g/dl * Total bilirubin \<= 1.5 x upper reference range * ASAT and ALAT \<= 2.5 x upper reference range, Alkaline Phosphatases \<= 5 x upper reference range * Serum creatinine \<= 120 µmol/l * Weight loss \< 10 % within last 3 months * Written inform consent

Exclusion criteria

* Infiltrative transglottic tumor or clinical cartilage invasion * Distant metastasis * Previous chemotherapy or radiotherapy * Contra-indication to chemotherapy

Design outcomes

Primary

Measure	Time frame
rate of laryngeal preservation	—

Secondary

Measure	Time frame
quality of life	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026