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

GOG-0238 - "A Randomized Trial of Pelvic Irradiation With or Without Concurrent Weekly Cisplatin in Patients with Pelvic-Only Recurrence of Carcinoma of the Uterine Corpus"

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.



Print This Summary

GYN Clinical Trial

CANCER TYPE: Endometrial
RESEARCH BASE: GOG-0238
NCT NUMBER: 00492778
HIPPA FORM: DOWNLOAD HIPPA FORM

Consent Form: VIEW CONSENT FORM

BRIEF DESCRIPTION

ENDOMETRIAL, Recur to pelvis &/or vagina only, complete THBSO for orig cancer; Pelvic RT +/- Concurrent Cisplatin (Sites must be credentialed for IMRT on this study & complete TRIAD access; RO must complete Knowledge Asmt Questionnaire see protocol.)  DCP-001 Eligible



NOTES


NOTES: 

1)  Sites must be credentialed for IMRT & treating RO must complete Knowledge Asmt Questionnaire prior to enrolling pts.  See the IROC Houston website under "Credentialing / GOG".

2)  Each site must complete the process to access TRIAD PRIOR to any patient enrollment (§5.13).

 

Treatment Plan     (Supplied Drug:  None)

 

RANDOMIZATION

Regimen I

Whole Pelvic RT:  4500cGy in 25 fx (180cGy/fx), to whole pelvis, M-F x approx 5 wks

Interstitial or Intracavitary Brachytherapy or External Beam boost*

Regimen II

Whole Pelvic RT:  4500cGy in 25 fx (180cGy/fx), to whole pelvis, M-F x approx 5 wks

Cisplatin:  40mg/m2/wk, IV, Days 1, 8, 15, 22 & 29 of external RT (4 hrs prior to RT)

Interstitial or Intracavitary Brachytherapy or External Beam boost*

 

*  3D conformal or IMRT boost is allowed for pts who are not brachytherapy candidates.



ELIGIBILITY

  • Complete hysterectomy & bilat salpingo-oophorectomy for original uterine carcinoma.
  • Bx w/histol-confirmed recur endometrial cancer confined to pelvis &/or vagina & no extrapelvic disease (incl positive periaortic or inguino-femoral nodes).
  • Endometrial cancer (endometrioid adenocarcinoma, adenocarcinoma w/squamous differentiation, mucinous adenocarcinoma, squamous cell carcinoma, mixed carcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, & serous adenocarcinoma histologies).
  • Complete workup prior to starting therapy to r/o mets including:  1) CT thorax w/IV contrast; & 2) CT pelvis/abdomen w/IV & PO contrast using multi-detector CT <5mm slice thickness.  If unable to tolerate contrast, MRI w/IV gadolinium should be used.  Do CXR first & if abnormal, do CT chest.
  • Prim debulking surgery b/f protocol therapy is allowed, including removal of gross symptomatic disease in pelvis &/or vagina.  No exenterative surgery.  Complete resection of gross recur disease is allowed.
  • Prior hormone &/or systemic chemo is allowed if completed >6 mos pre-study entry & evidence of disease after therapy.  No neo-adjuv chemo for present recur disease.
  • GOG perf status 0-2.
  • Estimated survival >3 mos.
  • ANC >1500/mm3; platelets >100,000/mm3; creat <IULN (if >IULN, CrCl must be >50mL/min); bili <1.5x ULN; SGOT & alk phos each <2.5x ULN; neuropathy (sensory & motor) <CTCAE v3.0 Grade 1.
  • If ureteral obstruction, must undergo stent or nephrostomy tube placement pre-study entry.
  • No prior vaginal, pelvic, or abdominal RT.
  • No septicemia or severe infection.
  • No circumstances precluding study completion or follow-up.
  • No renal abnormalities requiring modification of RT fields.
  • No prior invasive malignancies (except non-melanoma skin cancer) unless disease-free >5 yrs.  No prior cancer tx to contraindicate this study therapy.
  • No significant hx of cardiac disease (incl uncontrolled HTN, unstable angina, CHF, or uncontrolled arrthymias w/i 6 mos pre-regist).
  • No prior active collagen vascular disease.
  • PRE-STUDY REQUIREMENTS:
    • H&P
    • RT tx plan (must be known pre-entry, incl type of boost)*
    • GOG perf status**
    • CT chest/abdomen/pelvis*#
    • CBC/diff/platelets**
    • Lytes, BUN, creat, CrCl, Ca, Mg, PO4**
    • Bili, SGOT, alk phos, LDH**
    • Protoscopy##
    • Cytoscopy##
    • Renal US##
    • EKG*
    • Audiogram (if hx of hearing loss)*
    • Stained path slides for central review (w/i 6 wks of regist)
  • Signed informed consent & HIPAA.

*      Within 28 days prior to initiating protocol therapy.

**    Within 14 days prior to initiating protocol therapy.

#      If unable to tolerate contrast, MRI w/IV gadolinium should be used.  Do CXR first & if abnormal, do CT chest.

##   Optional






  © 2013-2018 All Rights Reserved. Privacy Policy | Terms & Conditions
NCI Community Oncology Research Program - Kansas City (NCORP-KC)
Questions? Call: +1-913-948-5588 | Contact Us
4121 W. 83rd St., Suite 259 Prairie Village, KS 66208 USA