HE-4 TRIAL
Prospective phase II trial on the prognostic andpredictive value of HE-4 regression duringneoadjuvant chemotherapy for advanced ovarian,Fallopian tube or primary peritoneal carcinoma
HE-4 TRIAL
Objectives
Primary:
To assess the significance of HE-4 regression as a predictor of optimalcytoreduction at interval debulking surgery (IDS) in women with ovarian,Fallopian tube or primary peritoneal carcinoma receiving 3 cycles of neo-adjuvant chemotherapy.
Secondary:
•To assess the significance of HE-4 regression as a prognostic indicator
in women with ovarian or primary peritoneal carcinoma receiving neo-
adjuvant chemotherapy;
•To assess the correlation between end of treatment HE-4 value and
Progression free survival (PFS) and Overall survival (OS);
•To assess the correlation between HE-4 regression and objective response
to neoadjuvant treatment as per Recist version 1.1 criteria;
•To assess the correlation between CA 125 and HE4 regression during the
neoadjuvant chemotherapy;
HE-4 TRIAL
Inclusion Criteria
•Female of age 18 years or older;
•Histologically or cytologically documented invasive epithelial ovarian cancer,
primary peritoneal carcinoma, or fallopian tube cancer not suitable of
primary cytoreduction. Subjects with borderline ovarian cancer and patients
with low malignant potential tumors are excluded;
•Measurable or evaluable disease per RECIST 1.1;
•ECOG performance status < 3;
•Life expectancy of at least 3 months;
•Adequate organ functions to receive neoadjuvant chemotherapy;
•No other invasive malignancy within the past 3 years except non-melanoma
skin cancer or in situ cervical cancer (patients with previous cancers may be
enrolled providing that no recurrences have be reported during the last 3 years);
•Written Informed Consent.
HE-4 TRIAL
Exclusion Criteria
•History of another neoplastic disease (except basal cell carcinoma or cervical
carcinoma in situ adequately treated) unless in remission for 3 years or longer;
•Known clinically relevant CNS metastases, unless treated and asymptomatic;
•Other serious illnesses that contraindicate performance of IDS.
HE-4 TRIAL
Statistical consideration
The sample size is estimated on the assumption that the expected HE4levels will decrease more than 40% during NACT.
Based on this feature, 80 patients will be included to achieve a statisticaldifference in HE4 levels (5% levels of significance and 95% power), beforeand after NACT.
To allow for a 20% rate due to exclusion for chemotherapy discontinuationor protocol deviation a total of 100 patients will be included
Stratification Factor:
•Residual tumor at IDS;
•Histotype;
•Antiangiogenic therapy
Study duration: 2 years
HE-4 TRIAL
Samples storage
•Blood samples will be collected at baseline (registration), at every cycles
and 30 days after the last chemotherapy cycle;
•Storage and analyses will be centralized at Istituto Nazionale Tumori,
Milan. 10 ml blood sample will be taken at each time point and stored at
-80°C.
HE-4 TRIAL
Administrative Information
•Academic trial
•NCI of Milan sponsor
•Data center: NCI of Milan (MITO center)
•Planned study start: March 2015
•NCI of Milan organize courier for samples
•Fujirebio Diagnostics support: supply of laboratory kits for HE-4 tests
To participate please contact:
domenica.lorusso@istitutotumori.mi.it
elisa.grassi@istitutotumori.mi.it