A randomized phase III study of oxaliplatin based chemotherapy versus combination chemotherapy of TS-1,irinotecan and bevacizumab as first line therapy for unresectable or recurrent colorectal cancer

Phase 3

• Conditions: unresectable or recurrent colorectal cancer

• Registration Number: JPRN-UMIN000007834
• Lead Sponsor: The Tokyo Cooperative Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

1.Histologically proven colorectal cancer (Adenocarcinoma)
2.Unresectable advanced/recurrent colorectal cancer
3.Aged over 20 years at the time of registration
4.Performance status(ECOG) :0,1
5.Patients with evaluable lesion
6.Previously not treated (chemotherapy, radiotherapy, etc.) for unresectable colorectal cancer
7.Able to receive oral treatment
8.Adequate organ function
9.Life expectancy estimated>=3 months
10.Written IC

Exclusion Criteria

1.History of serious drug hypersensitivity
2.Pregnant, lactating or women of
child-bearing potential. Men who want get partner pregnant.
3.Active infections
4.Serious complications
5.Significant abnormal ECG or history of cardiovascular disease
6.Peptic ulcers
7.Peripheral neuropathy
8.Watery diarrhea
9.Massive pleural effusion or ascites
10.Mechanical bowel obstruction
11.Symptomatic peritoneum dissemination
12.Brain metastasis
13.Current or previous (within the last 6 months) history of GI perforation
14.Hemoptysis (=> 2.5ml)
15.Previous history of thromboembolism, cerebral infarction, pulmonary infarction, interstitial pneumonia
16.Any surgical treatments within 28 days
17.Evidence of bleeding diathesis or coagulopathy
18.Ongoing treatment with anticoagulant or aspirin (> 325mg/day)
19.Administering transfusion within 14 days
20.Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
21.Under coutinuous steroid administration
22.Active hepatitis type HBs positive
23.Administration contraindication of 5-FU, Leucovorin, Capecitabine, TS-1, Oxaliplatin, CPT-11 and Bevacizumab
24.Any other cases who are regarded as inadequate for study enrollment by the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified