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Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC

G

Groupe Oncologie Radiotherapie Tete et Cou

Status and phase

Completed
Phase 3

Conditions

Oropharynx Cancer
Hypopharynx Cancer
Larynx Cancer
Oral Cancer

Treatments

Procedure: middle accelerated radiotherapy 70 Gy in 6 weeks
Procedure: Conventional radiotherapy 70 Gy in 7 weeks
Procedure: very accelerated radiotherapy 64.8 Gy in 3.5 weeks
Drug: 5FU, Paraplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00158652
GORTEC 99-02

Details and patient eligibility

About

This is a multicentric randomized phase III trial comparing conventional radiotherapy with concomitant chemotherapy versus accelerated radiotherapy with concomitant chemotherapy versus very accelerated radiotherapy in patients with stage III-IV head and neck squamous cell carcinoma. The main end point is the event free survival.

Full description

This is a multicentric randomized phase III trial comparing conventional radiotherapy with concomitant chemotherapy (arm A) versus middle accelerated radiotherapy with concomitant chemotherapy (arm B) versus very accelerated radiotherapy alone (arm C) in patients with stage III-IV head and neck squamous cell carcinoma (HNSCC). The main end point is the event free survival.

The treatments are

Bras A : Conventional radiotherapy given once daily, delivering 70 Gy in 7 weeks (5 fractions of 2 Gy per week) and chemotherapy: 5FU : 600 mg/m²/d, Paraplatin : 70 mg/m²/d, D1-4 and D22-25 and D43-46

Bras B: middle accelerated radiotherapy delivering 70 Gy in 6 weeks and chemotherapy: 5FU : 600 mg/m²/d, Paraplatin : 70 mg/m²/d, D1-5 and D29-33

  • first part : radiotherapy given once daily delivering 40 Gy in 4 weeks and 20 fractions of 2 Gy
  • second part : radiotherapy given twice daily with "concomitant boost" delivering 30 Gy in 20 fractions in 2 weeks (1,5 Gy x 2 / day)

Bras C: very accelerated radiotherapy given twice daily delivering 64.8 Gy in 3.5 weeks in 36 fractions of 1.8 Gy

Enrollment

840 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Squamous cell carcinoma of oral cavity, oropharynx, hypopharynx or larynx
  • Stage III-IV (UICC 1997): T2, T3 or T4 with N0-N3 or T0 with N2-N3
  • Not resectable
  • Karnofsky PS >= 70
  • Renal/liver/cardiac functions and blood counts compatible with the use of paraplatin and 5-FU
  • Informed consent signed

Exclusion criteria

  • Distant metastasis
  • Contra-indication to concomitant chemotherapy
  • History of cancer
  • History of head and neck radiotherapy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

840 participants in 3 patient groups

1
Active Comparator group
Treatment:
Procedure: Conventional radiotherapy 70 Gy in 7 weeks
Drug: 5FU, Paraplatin
2
Experimental group
Treatment:
Procedure: middle accelerated radiotherapy 70 Gy in 6 weeks
Drug: 5FU, Paraplatin
3
Experimental group
Treatment:
Procedure: very accelerated radiotherapy 64.8 Gy in 3.5 weeks

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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