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A Randomized Trial Evaluating a Very Intense Radiotherapy-Chemotherapy Regimen Versus a Very Accelerated Radiotherapy in Advanced Head and Neck Squamous Cell Carcinoma


Phase 2/Phase 3
40 Years
75 Years
Not Enrolling
Both
Oropharynx Cancer, Oral Cancer, Hypopharynx Cancer, Larynx Cancer

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Trial Information

A Randomized Trial Evaluating a Very Intense Radiotherapy-Chemotherapy Regimen Versus a Very Accelerated Radiotherapy in Advanced Head and Neck Squamous Cell Carcinoma


Patients with a palpable N2b-c or N3 HNSCC strictly unresectable were randomized to receive
either accelerated RT-CT delivering to the primary tumor 62-64 Gy / 5 weeks in 31-32
fractions of 2 Gy BID or very accelerated RT delivering 62-64 Gy in 31-32 fractions of 2 Gy
BID and 22-23 days. In the accelerated RT-CT arm, 3 cycles of CDDP 100 mg/m2 were delivered
at day 1, 16, 32 and 2 cycles of 5 Fu 1000 mg/m2 day 1 to 5 and 31 to 35. One month after
completion of the concomitant RT-CT, 2 additional cycles of CDDP-5FU were given in patients
responding (> 50%) to the initial course of RT-CT. The end points were event free survival
and survival.


Inclusion Criteria:



- palpable N2b-c or N3 (UICC 1997) squamous cell carcinoma of the head and neck
(oropharynx, oral cavity, hypopharynx or larynx)

- primary tumor and / or nodal extension strictly inoperable due to the extension of
the disease

- performance status of 0 to 2 (WHO scoring system)

- renal/liver/cardiac functions and blood counts compatible with the use of CDDP and
5-FU

- signed inform consent

Exclusion Criteria:

- distant metastasis

- previous history of cancer

- previous radiotherapy or chemotherapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event free survival (event = progressive disease or relapse or or death from any cause)

Principal Investigator

Jean Bourhis

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

France: Ministry of Health

Study ID:

VADN3

NCT ID:

NCT00162708

Start Date:

July 1996

Completion Date:

Related Keywords:

  • Oropharynx Cancer
  • Oral Cancer
  • Hypopharynx Cancer
  • Larynx Cancer
  • Head and neck squamous cell carcinoma
  • Radiotherapy
  • Chemotherapy
  • Laryngeal Neoplasms
  • Carcinoma, Squamous Cell
  • Mouth Neoplasms
  • Oropharyngeal Neoplasms
  • Hypopharyngeal Neoplasms
  • Head and Neck Neoplasms

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