NCI Community Oncology Research Program - Kansas City (NCORP-KC)
NCI Community Oncology Research Program - Kansas City (NCORP-KC)




NCI Community Oncology Research Program Protocol Summary

RTOG 0920 - "A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer"

The summary below serves as a brief review of the treatment plan and eligibility for the protocol.


This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
 

Please follow the "Full Protocol" link or contact NCORP-KC for complete protocol information.



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Head & Neck Clinical Trial

CANCER TYPE: Head & Neck
RESEARCH BASE: RTOG 0920
NCT NUMBER:
HIPPA FORM: DOWNLOAD HIPPA FORM

Consent Form: VIEW CONSENT FORM

BRIEF DESCRIPTION

ORAL CAVITY, OROPHARYNX, or LARYNX, squamous & its variants, T1 N1-2 or T2-4a N0-2 M0 w/no distant mets, post-total resection w/curative intent; EGFR (& HPV - oropharynx pts only) analyses ---> IMRT (or optional IGRT) +/- Cetuximab (See RT credentialing requirements in protocol.)



NOTES


See IMRT (or optional IGRT) credentialing requirements in Section 5.0 of protocol.

 

Treatment Plan    (Supplied Drug:  Cetuximab)

 

REGISTRATION

For all pts:  MANDATORY SUBMISSION of tissue for EGFR*

For oropharyngeal cancer pts:  MANDATORY ANALYSIS for HPV*

 

RANDOMIZATION

Arm 1 - RT Alone

RT:  2Gy/day, in 30 fx, total 60Gy**

 

Arm 2 - RT + Cetuximab

Cetuximab:  400mg/m2, IV over 120 mins, >5 days  prior to start of RT

RT:  2Gy/day, in 30 fx, total 60Gy**

Cetuximab:  250mg/m2/week, IV over 60 mins, x 6 wks

Cetuximab:  250mg/m2/week, IV over 60 mins, x 4 wks post-RT

 

*    EGFR analysis results are expected in 7-8 business days.  HPV analysis results (oropharyngeal pts only) are expected in 7-10 business days.  When results are known, the pt may be randomized.  The required analyses are not expected to cause delays in pts starting tx, since IMRT generally takes >7 days for institutional planning & QA procedures prior to start of RT.

**  IMRT is mandatory (60Gy prescribed to >95% of PTV).  If IGRT is used, it should be daily to ensure that error/variance is <3.5mm.  IGRT is mandatory when using reduced margins.  NOTE:  66Gy is permitted & optional.



ELIGIBILITY

  • Path (histol) confirmation of squamous cell carcinoma (includes verrucous carcinoma, spindle cell carcinoma, carcinoma NOS, etc.) of head/neck (oral cavity, oropharynx, or larynx).  No hypopharynx primaries.
  • Clinical T1 N1-2 or T2-4a N0-2 M0 with no distant mets.
  • Gross total resection of prim tumor w/curative intent <7 wks pre-regist.  Surgical path must show >1 of following "intermediate" risk factors:
    • Perineural invasion
    • Lymphovascular invasion
    • Single lymph node >3cm of >2 lymph nodes (all <6cm) [no extracapsular extension]
    • Close margin(s) of resection (cancer extending to w/i 5mm of surgical margin &/or an initially focally positive margin that is subsequently superseded by intraoperative negative margins).  Also, tumors w/focally positive margins in the main specimen but negative margins from re-excised samples in the region of the positive margin are allowed.
    • Path-confirmed T3 or microscopic T4a prim tumor. 
    • T2 oral cavity cancer w/>5mm depth of invasion.
  • Zubrod 0-1 w/i 2 wks pre-regist.
  • Age >18.
  • Within 4 wks pre-regist:  AGC >1500 cells/mm3; platelets >100,000 cells/mm3; Hgb >8.0g/dl (use of transfusion/other to achieve this is allowed).
  • Within 2 wks pre-regist:  Total bili <2x IULN; SGOT or SGPT <3x IULN; serum creat <2x IULN or CrCl >50ml/min (24-hr urine collection or estimated by Cockroft-Gault); negative serum pregnancy test (if applicable).  Also required:  Na, K, Cl, glucose, Ca, Mg, albumin.  If initial Mg <0.5mmol/L (1.2mg/dl), pt may receive corrective Mg supplementation, and should continue either prophylactic weekly IV Mg &/or PO Mg supplementation (investigator's discretion).
  • Men/Women of reproductive potential must use effective contraception.
  • No prior invasive malignancy (except non-melanoma skin cancer) unless disease-free >3 yrs.  Non-invasive cancers are permitted even if dxd & treated <3 yrs ago.  No simultaneous primaries or bilat tumors (except bilat tonsil cancers or pts w/T1-2 N0 M0 resected differentiated thyroid cancer).
  • Per op &/or path report, no positive margin(s) [tumor present at cut or inked edge of tumor], nodal extracapsular extension, &/or gross residual disease after surgery.  NOTE:  Tumors w/focally positive margins in the main specimen but negative margins from re-excised samples in the region of the positive margin are allowed (see §8.1).
  • No prior systemic chemo or anti-EGF therapy for study cancer.  Prior chemo or anti-EGF therapy for a different cancer is allowed.
  • No prior RT to region of study cancer that would result in overlap of RT fields.
  • No unstable angina &/or CHF requiring hospitalization w/i 6 mos pre-regist.
  • No transmural MI w/i 6 mos pre-regist.
  • No acute bacterial or fungal infection requiring IV antibiotics at regist.
  • No COPD exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at regist.
  • No idiopathic pulmonary fibrosis or other severe interstitial lung disease that requires oxygen therapy (or will require) w/i 1 yr pre-regist.
  • No hepatic insufficiency resulting in clinical jaundice &/or coagulation defects.  Lab tests for coagulation parameters are NOT required for study entry.
  • No AIDS based on current CDC definition.  HIV testing is NOT required for study entry.
  • No Grade 3-4 electrolyte abnormalities: 
    • Serum Ca (ionized or adjusted for albumin) <7mg/dl (1.75mmol/L) or >12.5mg/dl (>3.1mmol/L) despite intervention to normalize levels.
    • Glucose <40mg/dl (<2.2mmol/L) or >250mg/dl (>14mmol/L).
    • Mg <0.9mg/dl (<0.4mmol/L) or >3mg/dL (>1.23mmol/L) despite intervention to normalize levels.
    • K <3.5mmol/L or >6mmol/L despite intervention to normalize levels.
    • Na <130mmol/L or >155mmol/L despite intervention to normalize levels.
  • No prior allergic reaction to Cetuximab.
  • PRESTUDY REQUIREMENTS:
    • Tissue collection for EGFR (MANDATORY for all pts)#
    • HPV analysis (oropharynx cancer pts only)#
    • General H&P by Rad Onc &/or Med Onc*
    • ENT/Surgeon's exam (laryngopharyngoscopy [mirror &/or fiberoptic &/or direct procedure] is recommended, but not required)*
    • CT w/contrast (or CT/PET) &/or head/neck MRI (recommended w/i 4 wks pre-tx)
    • CXR (or chest CT or CT/PET)*
    • Path Asmt (gross total resection w/i 7 wks pre-regist)
    • Perf status**
    • CBC w/diff & AGC (w/i 4 wks pre-regist)
    • Bili, SGOT or SGPT**
    • Serum creat or CrCl**
    • Na, K, Cl, glucose, Ca, Mg, albumin**
    • Serum pregnancy test (if applicable)**
    • Dental eval (w/i 3 mos prior to start of tx)
    • Asmt of swallowing function (w/i 2 wks pre-tx)
    • Eval for G-tube placement (recommended w/i 4 wks pre-tx)
    • EKG (recommended w/i 8 wks pre-tx)
    • QOL/Functional asmts (w/pt's consent; may do online or hardcopy)

    *       Within 8 wks pre-regist

    **     Within 2 wks pre-regist

    #       Ship to NRG Oncology Biospecimen Bank via FedEx overnight delivery:  1) Representative H&E stained slides & 2) FFPE tissue from bx or surgical specimen or 6 unstained sections & three 3mm core punches from block (if unable to submit block).  Contact NCORP-KC for pre-paid FedEx shipping labels & FFPE specimen plug kit (if needed).  Oropharynx cancer pts must also allow use of submitted tissue for HPV analysis (processed using 4 unstained sections from the tissue block submitted for EGFR analysis). 

  • Signed informed consent, including consent for MANDATORY tissue submission for EGFR & HPV analyses (HPV for oropharyngeal pts only).





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