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CTSU N0577 - "Phase III Intergroup Study of Radiotherapy versus Temozolomide Alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide for Patients with 1p/19q Codeleted Anaplastic Glioma"
NOTES:
1) See Neurocognitive Certification requirement in protocol (MANDATORY). Examiners must be certified b/f enrolling any patients. Individuals certified for neurocognitive testing on other specific protocols w/i the past 12 mos (see Section 4.4112 in protocol) do not have to be re-certified, but are required to follow the notification instructions in Section 4.4112.
2) See IMRT certification requirement in protocol.
Treatment Plan (Supplied Drug: Temozolomide)
PRE-REGISTRATION (Central Pathology Review Submission)
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REGISTRATION / RANDOMIZATION (Central review confirmation & confirmation of 1p/19q Co-deleted status)
After Registration, the following must not be used: Surgical procedures for tumor debulking, other types of chemo, immunotherapy, or biologic therapy, or additional boost radiotherapy.
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Arm A
RT: 5940cGy/33fx, Days 1-5, weekly x 6 wks
Followed by 4-6 wk rest period
Arm B (see protocol for pre-tx regimen w/Pneumocystis carinii pneumonia [required])
RT: 5940cGy/33fx, Days 1-5, weekly x 6 wks
Temozolomide: 75mg/m2, PO, QD, weekly x 6 wks
Followed by 4 wk (+/- 3 days) rest period, then adjuv tx w/Temozolomide
Temozolomide: 150 or 200mg/m2*, PO, Days 1-5 (Wk 1), q 28 days x 6 cycles (option to extend to 12 cycles)
* 1st cycle of adjuv Temozolomide is given at 150mg/m2; dose escalated to 200mg/m2 in subsequent cycles in absence of toxicity.
Arm C (see protocol for pre-tx regimen w/Pneumocystis carinii pneumonia [required])
Temozolomide: 150 or 200mg/m2**, PO, Days 1-5 (Wk 1), q 28 days x 12 cycles
** 1st cycle of Temozolomide is given at 150mg/m2; dose escalated to 200mg/m2 in subsequent cycles in absence of toxicity.
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OBSERVATION UNTIL PD (q 12 wks x 2 yrs (max) from regist, then q 6 mos until PD or alternative tx)
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EVENT MONITORING (q 6 mos until death)
Eligibility
PRE-REGISTRATION
Must submit tissue for mandatory central path review & deletion status determination (ASAP post-surgery).
REGISTRATION
Age >18.
New dx & <3 mos from surgical dx.
Histol confirmation of anaplastic glioma (oligodendroglioma, mixed, or astrocytoma [WHO grade III], determined by pre-regist central path review, & tumor is also co-deleted for 1p & 19q. NOTE: Mixed gliomas are eligible, regardless of degree of astrocytic or oligodendrocytic predominance, as long as tumor is co-deleted for 1p & 19q.
Surgery <2 wks pre-regist & recovered from all side effects.
<21 days pre-regist: ANC >1500/uL; platelets >100,000/uL; Hgb >9.0g/dL; total bili <1.5x IUNL (mg/dL); SGOT <3x UNL (Units/L); creat <1.5x ULN (mg/dL).
Negative pregnancy test <7 days pre-regist (if applicable).
Willing and able to complete neurocognitive exam w/o assistance & QOL by themselves or w/assistance.
ECOG perf status 0-2.
Willing to provide tissue for translational research purposes.
No pregnant or nursing women. Men/Women of reproductive potential must use adequate contraception during this study & x 6 mos following completion of Temozolomide txs.
No prior surgery, RT, or chemo for any CNS neoplasm (hormones, vitamins, & growth factors are not considered chemo). EXCEPTION: Pts w/prior bx/resection showing low grade glioma, but now having a bx/resection showing anaplastic glioma & have not had any other tx (radiotherapy or chemo).
No co-morbid illnesses or other severe concurrent disease to preclude study participation & asmt of regimens (investigator's judgement).
No concomitant serious immuno-compromised status (other than that related to concomitant steroids).
No active uncontrolled systemic infection or HIV.
Must not be receiving any other investigational agent that would be considered a tx for the prim neoplasm.
No other active malignancy except non-melanoma skin cancer or in situ cervical carcinoma. NOTE: If there is a prior malignancy, must not be receiving other specific tx (other than hormonal) for their cancer.
No prior MI w/i past 6 mos or CHF requiring ongoing maintenance therapy for life-threatening ventricular arrhythmias.
No recent hepatitis infection or significant risk for reactivation of hepatitis (treating physician's judgement).
PRESTUDY REQUIREMENTS:
Path review & determination of deletion status*#@
RO consult*
H&P, wt, perf status, ht**
Neuro hx & exam**
Pregnancy test (if applicable, w/i 7 days pre-regist)
ANC, platelets, Hgb**
SGOT, alk phos, total bili, creat, calcium, phos, glucose, sodium, potassium**
Head MRI w/contrast or CT w/contrast (MRI preferred unless contraindications)**
Recording of steroid dose**
Optional research blood draw (collect post-regist, but b/f any tx)***
Mandatory research tissue$
Neurocognitive/QOL questionnaire booklets (Mandatory)**
* Pre-regist
** <21 days pre-regist
*** For banking. EDTA & Na heparin blood & EDTA plasma. Contact KCCOP for kit & smart shipper label.
# Allow 10 business days from time NCCTG receives ALL path materials & usable tissue to obtain deletion status & communicate to site.
@ Submit ASAP post-surg & prior to enrollment (pre-regist requirement for central review & deletion status): 1) All diagnostic slides; & 2) FFPE tissue blocks w/corresponding H&E (or 5 unstained slides w/1 corresponding H&E). Send to: NCCTG Operations Office; PC Office (Study N0577); Rochester, MN.
$ Submit <30 days post-regist (correlative studies): 1) All diagnostic slides; 2) FFPE tissue blocks w/corresponding H&E (or 6 unstained slides w/1 corresponding H&E); & 3) 15 unstained slides w/2 corresponding H&Es (#3 is mandatory unless specimens are exhausted/unavailable & there has been reasonable attempt to obtain; pt will still be eligible). NOTE: If FFPE tissue block was previously submitted for determination of deletion status, no additional tissue slides are required. These slides are required if unstained slides (instead of a tissue block) were originally submitted for the pre-regist requirement for determination of deletion status.
Signed informed consent.