Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC
NCT ID: NCT00158652
Last Updated: 2011-11-08
Study Results
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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COMPLETED
PHASE3
840 participants
INTERVENTIONAL
2000-03-31
2011-03-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Conventional radiotherapy 70 Gy in 7 weeks
2 gy per fraction, 1 fraction per day, 5 fractions per week
5FU, Paraplatin
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)
2
middle accelerated radiotherapy 70 Gy in 6 weeks
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
5FU, Paraplatin
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)
3
very accelerated radiotherapy 64.8 Gy in 3.5 weeks
2 fractions of 1.8 Gy per day for 64.8 Gy in 3.5 weeks
Interventions
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Conventional radiotherapy 70 Gy in 7 weeks
2 gy per fraction, 1 fraction per day, 5 fractions per week
middle accelerated radiotherapy 70 Gy in 6 weeks
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
2 fractions of 1.8 Gy per day for 64.8 Gy in 3.5 weeks
5FU, Paraplatin
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* Contra-indication to concomitant chemotherapy
* History of cancer
* History of head and neck radiotherapy
20 Years
75 Years
ALL
No
Sponsors
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Groupe Oncologie Radiotherapie Tete et Cou
OTHER
Responsible Party
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Principal Investigators
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Jean Bourhis, PhD
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Gilles Calais
Role: PRINCIPAL_INVESTIGATOR
CHU Tours
Locations
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CHU de Tours
Tours, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Other Identifiers
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GORTEC 99-02
Identifier Type: -
Identifier Source: org_study_id