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

G

Groupe Oncologie Radiotherapie Tete et Cou

Status and phase

Completed
Phase 2

Conditions

Hypopharynx Cancer
Larynx Cancer

Treatments

Drug: cetuximab
Procedure: Radiotherapy 70 Gy, 35 fractions
Drug: Cisplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00169247
GORTEC-TREMPLIN

Details and patient eligibility

About

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.

Full 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.

Enrollment

156 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

3

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems