JCOG2002: A randomized phase III study of thoracic radiotherapy for extensive stage small cell lung cancer

JRCT ID: jRCTs031210393

Registered date:27/10/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Extensive stage small cell lung cancer
• Date of first enrollment: 09/11/2021
• Target sample size: 330
• Study type: Interventional

Intervention(s)

Induction therapy
ACE therapy
Atezolizumab 1,200 mg/body (day 1)+CBCDA AUC 5 (day 1)+Etoposide 100 mg/m2 (day 1,2,3), every 3 weeks, up to 4 cycles
DPE therapy - Cisplatin
Durvalumab 1,500 mg/body (day 1)+Cisplatin 80 mg/m2 (day 1)+Etoposide 100 mg/m2 (day 1,2,3), every 3 weeks, up to 4 cycles
DPE therapy - CBCDA
Durvalumab 1,500 mg/body (day 1)+ CBCDA AUC 5 (day 1)+Etoposide 100 mg/m2 (day 1,2,3), every 3 weeks, up to 4 cycles

Group A: maintenance therapy only
Atezolizumab maintenance therapy
Atezolizumab 1,200 mg/body (day 1), every 3 weeks
Durvalumab maintenance therapy
Durvalumab 1,500 mg/body (day 1), every 4 weeks

Group B: maintenance therapy+chest radiation therapy
Atezolizumab maintenance therapy+chest radiation therapy
Atezolizumab 1,200 mg/body (day 1), every 3 weeks
chest radiation therapy:30Gy/10fr.
Durvalumab maintenance therapy+chest radiation therapy
Durvalumab 1,500 mg/body (day 1), every 4 weeks
chest radiation therapy:30Gy/10fr.

Outcome(s)

• Primary Outcome: Overall survival
• Secondary Outcome: Progression-free survival, Adverse event rate, Induction therapy response rate, Induction therapy complete response rate, Incidence rate of SVC syndrome / airway stenosis (>=Grade 2)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Primary registration criteria
(1) Cytologically or histologically confirmed small cell lung cancer. class IV or class V was required for cytology.
(2) Extensive stage was diagnosed by thoracoabdominal contrast-enhanced CT, FDG-PETand brain contrast-enhanced MRI.Lymph node metastasis exists either the supraclavicular/mediastinal lymph node or the ipsilateral hilar lymph node.
(3) Over 20 years old.
(4) Performance status 0, 1 or 2.
(5) Measureable or non-measureable.
(6) No history of radiation therapy or chemotherapy for small cell lung cancer.
(i) No prior palliative radiation therapy for non-central nervous system metastases within 7 days
(ii) No prior stereotactic irradiation for central nervous system metastases within 7 days
(iii) No prior whole-brain irradiation within 14 days
(7) No history of radiation therapy with supraclavicular, mediastinal, or hilar for other cancer types.
(8) Major organ function is preserved.
(i) Neutrophil count >= 1,500 /mm3
(ii) Hemoglobin >= 9.0 mg/dl
(iii) Platelet count >= 100,000 /mm3
(iv) T-bil <=1.5 mg/dL
(v) AST =< 100 U/L (=< 200 U/L in case of liver metastases)
(vi) ALT =< 100 U/L (=< 200 U/L in case of liver metastases)
(vii) Serum creatinine <=1.5 mg/dL
(viii) SpO2 >= 92%
(9) No active autoimmune disease.
(10) No serious tumor-related complications.
(11) Written informed consent.

Secondary registration selection criteria
(1) Primary registration was performed. Four course of ACE therapy or DPE therapy was completed, or only three course of ACE therapy or DPE therapy is completed due to adverse events.
(2) Following (i)-(iii) is satisfied.
(i) Contrast-enhanced CT after 2 courses of induction therapy does not show obvious progressions compared to CT before primary registration.
(ii) Contrast-enhanced CT after 4 courses of induction therapy does not show obvious progressions compared to CT after 2 courses of induction therapy.
(iii) No obvious progressions from the start of induction therapy.
(3) Within 7-42 days from the start of the final course of induction therapy.
(4) Within 64-182 days from the primary registration.
(5) Performance status 0 or 1.
(6) Judged that radiation therapy for the hilum and mediastinum was possible by consulting with a radiologist.
(7) Major organ function is preserved.
(i) Neutrophil count >= 1,500 /mm3
(ii) Hemoglobin >= 9.0 mg/dl
(iii) Platelet count >= 100,000 /mm3
(iv) T-bil <=1.5 mg/dL
(v) AST =< 100 U/L (=< 200 U/L in case of liver metastases)
(vi) ALT =< 100 U/L (=< 200 U/L in case of liver metastases)
(vii) Serum creatinine <=1.5 mg/dL
(viii) SpO2 >= 92%
(8) No drug-induced interstitial pneumonia or pulmonary fibrosis diagnosed by chest CT.
(9) No tracheoesophageal fistula, bronchoesophageal fistula, tracheal mediastinal fistula, or bronchial mediastinal fistula.

Exclude criteria

(1) Simultaneous or metachronous (within 2 years) double cancers , with the exception of intramucosal tumor curable with local therapy.
(2) Active infection requiring systemic therapy.
(3) Fever over 38 degrees Celsius
(4) Female during pregnancy, within 28 days of postparturition, or during lactation. Male who wants partner's pregnancy.
(5) Psychological disorder difficult to participate in this clinical study.
(6) Receiving continuous systemic corticosteroid or immunosuppressant treatment.
(7) Uncontrollable diabetes mellitus.
(8) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration. Uncontrolled valvular disease, dilated cardiomyopathy, and hypertrophic cardiomyopathy.
(9) Interstitial pneumonia or pulmonary fibrosis diagnosed by CT.
(10) Positive for HBs antigen.

Related Information

• Primary Sponsor: NIHO Seiji
• Secondary Sponsor: SASAKI Tomonari
• Source(s) of Monetary Support: National Cancer Center Japan