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

NRG-GY006 - "A Randomized Phase II Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal 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.



Print This Summary

GYN Clinical Trial

CANCER TYPE: Cervical
RESEARCH BASE: NRG
NCT NUMBER: NCT02466971
HIPPA FORM: DOWNLOAD HIPPA FORM

Consent Form: VIEW CONSENT FORM

BRIEF DESCRIPTION

Uterine cervix Stg. IB2, II, IIIB, IVA or Vagina Stg. II-IVA, squamous, adenoca, or adenosquamous. No para-aortic LN mets on PET. Radiation/Cisplatin vs Radiation/Cisplatin/Triapine.



NOTES


ALL SITES MUST COMPLETE IMRT CREDENTIALING

PLEASE SEE THE IROC WEBSITE FOR FURTHER INFORMATION

 

 

Treatment Plan     (Supplied Drug:  Triapine)

Arm 1: 

Radiation - 45 Gy / 25 fractions of 1.8 Gy + 5.4Gy / 3 fraction parametrium  boost + 40 Gy LDR or 30 Gy HDR brachytherapy

Cisplatin - X1 weekly cisplatin 40 mg/m2 (maximum 70 mg) days 2, 9, 16, 23, 30 of radiation (5 total infusions; a sixth administration on day 36 is permissible at the treating physician’s discretion).

Arm 2:

Radiation - 45 Gy / 25 fractions of 1.8 Gy + 5.4Gy / 3 fraction parametrium  boost + 40 Gy LDR or 30 Gy HDR brachytherapy

Cisplatin - X1 weekly, 40 mg/m2 (maximum 70 mg) days 2, 9, 16, 23, 30 of radiation (5 total infusions; a sixth administration on day 36 is permissible at the treating physician’s discretion).

Triapine: X3 weekly, 25 mg/m2 (maximum 50 mg) days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, 33 of radiation (15 total infusions).



ELIGIBILITY

  • Patient has pathologic diagnosis of stage IB2 (> 5 cm), II, IIIB or IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix or stage II-IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the vagina not amenable to curative surgical resection alone. The presence or absence of para-aortic lymph node metastasis will be based on pre-therapy 18F-FDG PET/CT. If the baseline 18F-FDG PET/CT identifies hypermetabolic para-aortic disease, such patients will NOT be eligible. The patient must be able to tolerate imaging requirements of an 18F-FDG PET/CT scan. 
  • Patient must provide study specific informed consent prior to study entry.
  • Patient must have a GOG performance status of 0, 1, or 2 or equivalent (Appendix A).
  • Patient must have adequate organ and marrow function as defined below:
    • absolute neutrophil count > 1,500/μL
    • platelets > 100,000/μL
    • hemoglobin > 10 g/dL
    • total bilirubin < 2.0 mg/dL
    • AST(SGOT)/ALT(SGPT) < 2.5 X institutional upper limit of normal
    • PT/aPTT < 1.5 X institutional upper limit of normal
    • Creatinine ≤ 1.5 mg/dL to receive weekly cisplatin*
    • Patients whose serum creatinine is between 1.5 and 1.9 mg/dL are eligible for cisplatin if there is no hydronephrosis and the estimated creatinine clearance (CCr) is ≥ 30 ml/min. For the purpose of estimating the CCr, the formula of Cockcroft and Gault for females should be used:
    • CCr = 0.85 x (140-age) x IBW / (Scr x72) where age is the patient’s age in years (from 20 to 80 years), Scr is the serum creatinine in mg/dL, and IBW is the ideal body weight in kg (according to the calculation IBW = 45.5 kg + 2.3 kg for each inch over 5 feet).Patient does not have uncontrolled diabetes mellitus (i.e., fasting blood glucose >200 mg/dL).
  • Patient has a life expectancy of greater than 20 weeks.
  • Age is ≥ 18 years.
  • Patient does not have known brain metastases (testing optional).
  • Patient does not have known human immunodeficiency virus syndrome(HIV, testing optional). Known HIV-positive patients receiving combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with triapine.
  • Patient does not have a known allergy to compounds of similar or biologic composition as triapine.
  • Patient does not have known glucose-6-phosphate dehydrogenase (G6PD) deficiency as the condition interferes with triapine antidote metabolism (G6PD testing optional).
  • Patient is not actively breastfeeding (or has agreed to discontinue breastfeeding before the initiation of protocol therapy).
  • Patient must not have another concurrent active invasive malignancy.
  • Patient must not have had a prior invasive malignancy diagnosed within the last three years (except [1] non-melanoma skin cancer or [2] prior in situ carcinoma of the cervix). Patients are excluded if they have received prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissues at the discretion of the treating physician.
  • Patient must not have uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within six months of protocol initiation, cardiac arrhythmia within six months of protocol initiation; known inadequately controlled hypertension; clinically significant pulmonary disease including dyspnea at rest, or patients requiring supplemental oxygen, or poor pulmonary reserve; proteinuria or clinically significant renal function impairment (baseline serum creatinine >2 mg/dL); or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patient must not be receiving another investigational agent for the treatment of cancer.
  • Patient must not be pregnant. Patient must agree to use two forms of birth control if they are of child-bearing potential.





  © 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