Preliminary Results of the GORTEC 96-01 Randomized Trial, Comparing Very Accelerated Radiotherapy Versus Concomitant Radio-Chemotherapy for Locally Inoperable HNSCC

William Levin, MD
University of Pennsylvania Cancer Center
Last Modified: November 5, 2001

Presenter: J. Bourhis
Presenter's Affiliation: Institut Gustave Roussy, Villejuif, France
Type of Session: Plenary


  • There is some clinical evidence that radiation therapy administered over a shorter period of time offers better tumor control by decreasing the ability of cancer cells to repair themselves from radiation-induced damage.
  • Combined chemotherapy and radiation therapy regimens are also used in the treatment of advanced cancers.
  • It is unclear as to if one of these approaches is superior.

    Materials and Methods

  • Patients with advanced stage squamous cell cancer of the head and neck were randomized to receive either modified fractionated radiotherapy (RT) or concomitant radio-chemotherapy (RT-CT)
  • 109 patients were randomized between very accelerated RT (62-64 Gy/3weeks) and moderately accelerated RT (62-64 Gy/5 weeks) + CDDP 100 mg/m2 Days 1, 16 and 32 and 5FU 1g/m2/day, days 1 to 5 and 31 to 35.
  • In the RT-CT arm, 2 additional cycles of CDDP-5FU were given whenever possible, 28 days and 56 days after the local treatment.
  • 90% of patients had T4 tumors or N3 nodal disease.
  • The majority of patients had oropharynx cancer.


  • There was a 96% incidence of grade 3/4 mucositis in the Accelerated Group, versus 81% in the RT-CT Group.
  • For both groups, there was only about 30% locaregional control.
  • There was no significant difference between groups in terms of survival or incidence of distant metastases.

    Author's Conclusions

  • Accelerated radiotherapy is no better than chemoirradiation in terms of locoregional control, distant metastases, or overall survival.

    Clinical/Scientific Implications

  • Local control of advanced head and neck cancers is necassary before improvements in survival can be achieved.
  • Accordingly, the development of other chemotherapeutic and biologic therapies are needed.

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