Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier:
NCT00158652
First received: September 9, 2005
Last updated: November 7, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Oral Cancer
Oropharynx Cancer
Hypopharynx Cancer
Larynx Cancer
Procedure: Conventional radiotherapy 70 Gy in 7 weeks
Procedure: middle accelerated radiotherapy 70 Gy in 6 weeks
Procedure: very accelerated radiotherapy 64.8 Gy in 3.5 weeks
Drug: 5FU, Paraplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Groupe Oncologie Radiotherapie Tete et Cou:

Primary Outcome Measures:
  • Event free survival (event=progression, relapse, death from any cause) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Loco regional control [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: early and late ] [ Designated as safety issue: Yes ]

Enrollment: 840
Study Start Date: March 2000
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Procedure: Conventional radiotherapy 70 Gy in 7 weeks
2 gy per fraction, 1 fraction per day, 5 fractions per week
Drug: 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)
Experimental: 2 Procedure: 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
Drug: 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)
Experimental: 3 Procedure: 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

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

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158652

Locations
France
CHU de Tours
Tours, France, 37 044
Institut Gustave Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Groupe Oncologie Radiotherapie Tete et Cou
Investigators
Principal Investigator: Jean Bourhis, PhD Gustave Roussy, Cancer Campus, Grand Paris
Principal Investigator: Gilles Calais CHU Tours
  More Information

Additional Information:
No publications provided

Responsible Party: Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier: NCT00158652     History of Changes
Other Study ID Numbers: GORTEC 99-02
Study First Received: September 9, 2005
Last Updated: November 7, 2011
Health Authority: France: Ministry of Health

Keywords provided by Groupe Oncologie Radiotherapie Tete et Cou:
Head and neck squamous cell carcinoma
Radiotherapy
Chemotherapy

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on October 23, 2014