JCOG1305: Interim response adapted strategy for the advanced stage of Hodgkin Lymphoma
- Conditions
- Previously untreated advanced stage Hodgkin lymphoma
- Registration Number
- JPRN-jRCTs031180218
- Lead Sponsor
- AGAI Hirokazu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 93
1) Histologically diagnosed as classical Hodgkin lymphoma according to WHO classification 2008.
2) Clinical stage III or IV, or clinical stage IIB with bulky mediastinal lesion or continuously invasive lesion to extranodal tissues.
3) No central nervous system involvement
4) Aged 16 to 60 years old at enrollment
5) ECOG Performance status: 0-2
6) Having measuralble lesion (fulfill the 3 following criteria)
(i) lymph node or extranodal disease diagnosed as Hodgkin lymphoma by imaging, histopathological or cytopathological method.
(ii) measurable lesion by CT scan (transverse imaging with bidimensional measurements)
(iii) longest transverse diameter for lesions of 1.5 cm or more.
7) No previous anti-cancer treatment (chemotherapy and/or radiation) except for hormone therapy
8) Meet all of the following:
(i) absolute neutrophil count: no less than 1,000/mm3
(ii) platelet count: no less than 100,000/mm3
(iii) total bilirubin: 2.0 mg/dL or below
(iv) AST(GOT) : no more than 150 U/L
(v) ALT(GPT) : no more than 150 U/L
(vi) serum creatinine: 1.6 mg/dL or below (male), 1.2 mg/dL or below (female)
(vii) fasting blood glucose: 150 mg/dL or below
(viii) PaO2 (room air): at least 70 torr
9) ECG: neither ischemic change nor arrhythmia requiring medical intervention
10) Cardiac ejection fraction: at least 50%
11) Written informed consent by the patient (If the patient's age is under 20 years old, the additional consent must be obtained from the patient's parent or legal guardian.)
1) Synchronous or metachronous malignancy
2) Active infection requiring systemic treatment
3) Pregnant or nursing women
4) Psychiatric disease
5) Continuous systemic treatment with steroids or other immunosuppressive drugs
6) Insulin-dependent or uncontrollable diabetes mellitus
7) Unstable angina pectoris, or history of myocardial infarction within six months
8) Seropositive for HBsAg or anti-HCV antibody
9) Seropositive for anti-HIV antibody or unexamined
10) Interstitial pneumonia, pulmonary fibrosis or severe pulmonary emphysema on chest CT
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2-year progressin-free survival among all eligible patients and among inteim PET-positive patients (Co-primary endpoints)
- Secondary Outcome Measures
Name Time Method overall survival, event-free survival, complete response rate, incidence of adverse events, incidence of severe adverse events, incidence of secondary malignancy, incidence of per-protocol in terms of interim PET