Download 0920 Frequently Asked Questions

0920 Frequently Asked Questions
1. Do we use the same weight to calculate cetuximab doses for all 11 doses?
Patients should be weighed weekly and if there is a weight change by 10% or
more, then the dose should be recalculated. If the change is < 10%, then the dose
can be kept the same.
2. Can loading dose be given on any day?
Loading dose can be given on Monday, Tuesday or Wednesday only. There has to
be at least 5 days between the loading dose and the first concurrent cetuximab and
first radiation treatment. Concurrent cetuximab must be given on Monday or
Tuesday.
3. Should cetuximab be given prior to or after radiation treatment?
It can be given prior to or after radiation treatment.
4. If my patient is edentulous, does the patient still needs to see a Dentist as
specified under section 4.1.1?
No, a note from a Radiation Oncologist and /or ENT doctor would be sufficient.
5. If a cetuximab dose is held for toxicity, do we make up the dose?
No, doses held for toxicity are not made up. If a cetuximab dose is missed for
reasons unrelated to drug toxicity, then the missed dose may be made up at the
discretion of the investigator, at the next appropriate time point according to
Section 7.1.1.
6. If radiation treatment is delayed, can patient receive maintenance dose while
receiving RT?
Yes, there should be no gap.
7. Can a treatment planning CT be used for eligibility criteria 3.1.2.3 (Chest
imaging)?
Yes, as long as the Radiation Oncologist reviews the treatment planning CT with
the Radiologist and dictates a note for source documentation. The treatment
planning CT must be from prior to registration.
8. Will a neck CT be sufficient for follow up assessment?
Yes, many institutional Radiology departments simply refer to H&N CT as a neck
CT.
9. If my patient had the primary resection and neck dissection on different
dates, which date would I use as date of surgery for eligibility criteria 3.1.3?
The date of final surgery should be used.
10. If the clinical stage is T3N2 and the pathologic stage is T3N3, is the patient
eligible?
No, N3 nodal disease is not allowed in this protocol.
11. My patient underwent a neck dissection for unknown primary cancer,
showing 3 positive nodes without extracpasular extension. Despite our best
efforts, we cannot identify a primary tumor. Is the patient eligible?
Unknown primary cancer is not eligible due to the concern that it could represent
occult nasopharynx, hypopharynx or even cancer from a site below the clavicles.
12. What do you do if the clinical size of the tumor was slightly above 2 cm, but
the final pathology report states that the tumor was 1.8 or 1.9 cm in its
greatest dimension?
Pathology measurement of the gross tumor is often an underestimate of the true
size of the tumor, due to the fixation process. If you are confident that the clinical
stage of the tumor was T2, then that should be considered the final stage.
13. What do you do if you can’t be certain if the cancer arose in the oral cavity
versus oropharynx? Larynx versus hypopharynx?
Hypopharynx cancers are ineligible, while oropharynx cancers require central
facility p16 testing. Thus, accurate identification of the primary site is important
for this study, recognizing that 100% certainty is not always possible. In some
cases, it can be difficult and/or subjective to determine precisely where the tumor
originated. This does not mean the patient is ineligible. Careful review of all the
preoperative data, operative reports and pathology reports by multiple oncologists
can be helpful. If you are uncertain, please feel free to contact one or all of the
study chairs (Drs. Machtay, Holsinger and Siu) for individual cases with regards
to these subtle staging and substaging distinctions.
14. Do I submit tissue before I register to the study?
No, patients must be registered to Step 1 first before tissue can be submitted to
Biospecimen Resource. Use the case # obtained from Step 1 registration to label
all specimen submissions.
15. When do I proceed to 2nd Step Registration?
The person who registered the case will receive an email notification from the
RTOG Registration Desk before you can register to Step 2.