Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00158652

Enrollment

840

Registered

2005-09-12

Start date

2000-03-31

Completion date

2011-03-31

Last updated

2011-11-08

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

Conditions

Hypopharynx Cancer, Larynx Cancer, Oral Cancer, Oropharynx Cancer

Keywords

Head and neck squamous cell carcinoma, Radiotherapy, Chemotherapy

Brief summary

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.

Detailed 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

Interventions

PROCEDUREConventional radiotherapy 70 Gy in 7 weeks

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

PROCEDUREmiddle 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

PROCEDUREvery 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

DRUG5FU, 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Event free survival (event=progression, relapse, death from any cause)	3 years

Secondary

Measure	Time frame
Survival	3 years
Loco regional control	3 years
Toxicity	early and late

Countries

France

Outcome results

None listed

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