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NCT Number: NCT00158652

Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC

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.

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Key information

Conditions

Oral Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Hypopharyngeal Neoplasms Hypopharynx Cancer Laryngeal Diseases Laryngeal Neoplasms Larynx Cancer Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Oropharyngeal Neoplasms Oropharynx Cancer Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU de Tours, Tours, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional radiotherapy 70 Gy in 7 weeks

Procedure

2 gy per fraction, 1 fraction per day, 5 fractions per week

middle accelerated radiotherapy 70 Gy in 6 weeks

Procedure

5 x 2gy/week until 40 Gy in 20 fractions and 4 weeks, then 2 fractions of 1.5Gy per day for 30 additional Gy in 2 weeks

very accelerated radiotherapy 64.8 Gy in 3.5 weeks

Procedure

2 fractions of 1.8 Gy per day for 64.8 Gy in 3.5 weeks

5FU, Paraplatin

Drug

5FU 600mg/m²/D, Paraplatin 70mg/m²/D In arm 1: D1-4, 3 cycles during Rth (D1, D22, D43) In arm 2: D1-5, 2 cycles during Rth (D1, D29)

Primary outcomes

  1. Event free survival (event=progression, relapse, death from any cause)

    Time frame: 3 years

Secondary outcomes

  1. Survival

    Time frame: 3 years

  2. Loco regional control

    Time frame: 3 years

  3. Toxicity

    Time frame: early and late

Sponsors and collaborators

Lead sponsor

Groupe Oncologie Radiotherapie Tete et Cou

Other

Registry information

Official study title

Phase III Trial Comparing Conventional RT With Concomitant CT Versus Accelerated RT With Concomitant CT Versus Very Accelerated RT Alone in Patients With Head and Neck Squamous Cell Carcinoma

Important dates

Study start
2000
Primary completion
2011
Study completion
2011
First posted
Sep 12, 2005
Registry last updated
Nov 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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