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SUMMARY OF CHANGES

RTOG 96-10 Recurrent H&N

September 8, 1998

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The following changes have been made:

Eligibility Checklist (p.2) Added

Will any component of the patient’s care be given at a VA or military facility?

Section 6.1 Added

If the patient misses more than two days, i.e., 4 fractions, make up missed treatments, with chemotherapy, the alternate week, i.e., the week the patient is on break.

Section 7.4.6 (new) Adherence to Protocol Guidelines

The protocol requires that a CBC be obtained at the beginning of each treatment week. It is critical that this timing be followed. Studies obtained earlier may not fully reflect the developing hematologic toxicity. Secondly, the dose modification guidelines require that the granulocyte count be > 2,000/m³. It is also important that this guideline be followed. On review of patients entered to date, the two patients who suffered fatal leukopenia-associated sepsis had violations of these guidelines. Even following these guidelines closely will not eliminate the possibility of grade 4 myelosuppression and patients must be followed with this possibility in mind. Close adherence to the dose modification guidelines should ensure even greater safety in the utilization of this therapy.

Section 12.1 The M2 is no longer required.