A Multinational, Randomized, Phase III Study of XELIRI with/without Bevacizumab versus FOLFIRI with/without Bevacizumab as Second-line Therapy in Patients with Metastatic Colorectal Cancer.

Conditions

Patients with 2nd-line treatment of mCRC

Takeshi Kato, Yoshinori Kagawa, Mitsuyoshi Ota, Akitaka Makiyama, Tadamichi Denda et al. (14 authors)

Annals of Oncology2018-10-011 citations

A multinational, randomized, phase III trial of XELIRI with or without bevacizumab versus FOLFIRI with or without bevacizumab as second-line therapy for metastatic colorectal cancer: Safety analysis of Asian XELIRI project (AXEPT).

Masato Nakamura, Tae Won Kim, Rui‐Hua Xu, Young Suk Park, Yong Sang Hong et al. (20 authors)

Journal of Clinical Oncology2017-02-013 citations

10.1200/jco.2017.35.4_suppl.681

Study protocol of the Asian XELIRI ProjecT (AXEPT): a multinational, randomized, non-inferiority, phase III trial of second-line chemotherapy for metastatic colorectal cancer, comparing the efficacy and safety of XELIRI with or without bevacizumab versus FOLFIRI with or without bevacizumab

Masahito Kotaka, Rui‐Hua Xu, Kei Muro, Young Suk Park, Satoshi Morita et al. (25 authors)

Chinese Journal of Cancer2016-12-0115 citations

10.1186/s40880-016-0166-3

A multinational, randomized, phase III trial of XELIRI (+bevacizumab) versus FOLFIRI (+bevacizumab) as the second-line chemotherapy for metastatic colorectal cancer: Asian XELIRI project (AXEPT).

Kei Muro, Tae Won Kim, Young Suk Park, Hiroyuki Uetake, Tomohiro Nishina et al. (19 authors)

Journal of Clinical Oncology2016-02-013 citations

10.1200/jco.2016.34.4_suppl.tps780

Interventions

Arm A: FOLFIRI +/- Bevacizumab (CPT-11:180 mg/m2) Arm B: Tri-weekly XELIRI +/- Bevacizumab (CPT-11: 200 mg/m2, Capecitabine: 1600 mg/m2/day x14 days)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically-confirmed inoperable colorectal adenocarcinoma excluding vermiform appendix cancer and anal canal cancer. 2) Age >=20 years at the time of informed consent 3) ECOG PS of 0-2 4) Written informed consent 5) Life expectancy of at least 90 days 6) Withdrawal from first-line chemotherapy(regardless of containing molecular-targeted drugs)for metastatic colorectal cancer due to intolerable toxicity or progressive disease, or relapse within 180 days after the last dose of adjuvant chemotherapy. 7) Adequate organ function according to following laboratory values obtained within 14 days before enrolment(excluding patients who received blood transfusions or hematopoietic growth factors within 14 days before the laboratory test)

Exclusion criteria

Exclusion criteria: 1)Contraindications of each protocol drugs 2)History of other malignancy with a disease-free survival<5 years 3)Radiological evidence of brain tumor or brain metastases 4)Active infection including hepatitis 5)Previous treatment with irinotecan hydrochloride 6)Pregnant or lactating females, and males and females unwilling to use contraception 7)Requires continuous treatment with systemic steroids 8)Psychiatric disability that would preclude study compliance 9)Otherwise determined by the investigator to be unsuitable for participation in the study <In case of combination with Bevacizumab> 10)Concurrent or recent (within 1 year before enrollment) gastrointestinal perforation 11)Unhealed wound, gastrointestinal ulcer, or traumatic fracture 12)Current or recent(within 1 year before enrollment)thromboembolism or cerebrovascular disease 13)Uncontrolled hypertension 14)Urine dipstick for proteinuria>+2

Design outcomes

Primary

Measure	Time frame
Overall Survival	—

Secondary

Measure	Time frame
PFS, TTF, ORR, DCR, RDI, Safety, Correlation between UGT1A1 polymorphisms and Safety	—

Countries

Japan,Asia(except Japan)

Contacts

Public ContactYumi Miyashita

NPO Epidemiological and Clinical Research Information Network (ECRIN) Aichi Branch

axept@ecrin.or.jp0564-66-1220

Outcome results

None listed