| Exclusion Criteria: | 1) Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for >/= 3 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible).
2) Recurrent or multifocal malignant gliomas
3) Metastases detected below the tentorium or beyond the cranial vault.
4) Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable, except prior temozolomide or bevacizumab. Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted.
5) Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields.
6) Severe, active co-morbidity as follows: a) Unstable angina and/or congestive heart failure within the last 6 months. b) Transmural myocardial infarction within the last 6 months. c) Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of >/= 2 mm using the analysis of an EKG performed within 14 days of registration . d) New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to registration. e) History of stroke, cerebral vascular accident (CVA) or transient ischemic attack within 6 months
7) ( 6. continued) f) Serious and inadequately controlled cardiac arrhythmia. g) Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection) or clinically significant peripheral vascular disease. h) Evidence of bleeding diathesis or coagulopathy. i) Serious or non-healing wound, ulcer, or bone fracture or history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration, with the exception of the craniotomy for tumor resection.
8) (7. continued) j) Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration. k) Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration. l) Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.
9) (8. continued) m) Acquired immune deficiency syndrome (AIDS) based upon current Center of Disease Control (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. n) Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity.
10) (9. continued) o) Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.
11) Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
12) Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant due to study drug.
13) Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study.
14) For ACRIN 6686 Advanced Imaging: Inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker). |