Carboplatin plus nab-Paclitaxel versus docetaxel for elderly squamous non-small cell lung cancer (CAPITAL study)

Conditions

Eldery patients with advanced squamous non-small-cell lung cancer

Kogure Y, Iwasawa S, Saka H, Hamamoto Y, Kada A, Hashimoto H, Atagi S, Takiguchi Y, Ebi N, Inoue A, Kurata T, Okamoto I, Yamaguchi M, Harada T, Seike M, Ando M, Saito AM, Kubota K, Takenoyama M, Seto T, Yamamoto N, Gemma A.

2021-12-0127 citations

10.1016/s2666-7568(21)00255-5

A randomized phase III study comparing carboplatin with nab-paclitaxel versus docetaxel for elderly patients with squamous-cell lung cancer: Capital study.

Yoichiro Hamamoto, Yoshihito Kogure, Akiko Kada, Hiroya Hashimoto, Shinji Atagi et al. (18 authors)

Journal of Clinical Oncology2021-05-202 citations

10.1200/jco.2021.39.15_suppl.9031

A Randomized Phase III Study Comparing Carboplatin With Nab-Paclitaxel Versus Docetaxel for Elderly Patients With Squamous-Cell Lung Cancer: Study Protocol.

Kogure Y, Saka H, Takiguchi Y, Atagi S, Kurata T, Ebi N, Inoue A, Kubota K, Takenoyama M, Seto T, Kada A, Yamanaka T, Ando M, Yamamoto N, Gemma A, Ichinose Y.

2018-05-198 citations

10.1016/j.cllc.2018.05.005

Interventions

A: Docetaxel (60 mg/m2) given on day 1 every 3 weeks until disease progression. B: Carboplatin (AUC 6) given on day1 plus nab-paclitaxel (100 mg/m2) given on day 1, 8, 15 every 3 weeks until disease p

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed advanced squamous non-small-cell lung cancer 2) Clinical stage IIIB (not amenable to curative radiation), IV or recurrent disease 3) Regardless of the presence of measurable lesions 4) 70 years of age or older 5) Performamne status of 0 or 1 6) Adequate organ funcion 7) life expectancy 12 weeks or more at day1 8) Written informed consent

Exclusion criteria

Exclusion criteria: 1) symptomatic central nervous system metastases 2) A past hypersensitive for polysorbate or albmin 3) peripheral neuropathy CTCAE Grade 2 or more 4) uncontrolled pericardial or pleural effusion or ascites 5) prior palliative radiotherapy for metastatic lesion within 14 days before registration 6) Synchronous or metachronous active double malignancies 7) Infectious disease requiring systemic treatment or severe complications 8) do not consent to contraception 9) Positive for HBs antigen 10) positive for HBs antibody or HBc antibody, and positive for HBV-DNA 11) patients who have been judged by the invedtigator to be inappropriate in this clinical trial for other reasons

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

Measure	Time frame
Progression-free survival, response rate, toxicity, quality of life	—

Countries

Japan

Contacts

Public ContactYutaka Ito

National Hospital Organization Nagoya Medical Center Department of Clinical Research Management, Clinical Research Center

capital.office@nnh.go.jp052-951-1111

Outcome results

None listed