Switch Maintenance Study

JRCT ID: jRCT1051180117

Registered date:11/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Colorectal cancer
• Date of first enrollment: 10/01/2018
• Target sample size: 55
• Study type: Interventional

Intervention(s)

CapeOX+Bev ;Capecitabine1000mg/m2 oral administration twice a day Day1-15+Oxaliplatin130mg/m2 120minute DIV+Bevacizumab5.0 mg/kg given on day 1,15
FOLFOX+Bev;Oxaliplatin85mg/m2 120minute DIV+LEVOFOLINATE200mg/m2 120minute DIV+Fluorouracil400mg/m2 rapid DIV+Fluorouracil2400mg/m2 46minute DIV+Bevacizumab DIV5.0 mg/kg Day1,15

TAS-102+Bev;TAS-102 35 mg/m2/time,oral administration twice a day Day1-5,
TAS-102 oral administration twice a day Day8-12+Bevacizumab DIV5.0 mg/kg Day1,15

Outcome(s)

• Primary Outcome: Progression free survival
• Secondary Outcome: Overall survival, Response rate, Disease control rate, Rechallenge rate of oxaliplatin, Safety; periods of maintenance therapy, dose intensity, adverse event, total dose of oxaliplatin

Key inclusion & exclusion criteria

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

Include criteria

1) Historical or cytological documentation of adenocarcinoma of the colon or rectum
2) First line chemotherapy and non-resectable advanced colorectal cancer. If patients were performed adjuvant chemotherapy, the period until first line chemotherapy has to be at least 6 months.
3) Male or female patients >= 20
4) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
5) Adequate bone marrow, liver and renal functions as assessed by the following laboratory requirements conducted within 14 days of starting study treatment:
1. Absolute neutrophil count >= 1500 /mm3
2. Hemoglobin >= 9.0 g/dl
3. Platelet >=100000 /mm3
4. Total bilirubin <=1.5 ml/dl
5. AST and ALT <=100 IU/l
6. Creatinine <= 1.5 mg/dl
6) Life expectancy of at least 90 days.
7) Patients must have measurable or non measurable disease according to RECIST version 1.1
8) Induction chemotherapy was done by CapeOX+Bevacizumb or FOLFOX+Bevacizumab. Except the induction therapy done by other approved standard therapies which include irinotecan or anti-EGFR drug.
9) Conduct a first line induction chemotherapy with bevacizumab, oxaliplatin, and fluoropyrimidine. Induction therapy will be stop systematically for 3 to 4 months then; the chemotherapy switch to TAS-102 plus bevacizumab; expected oxaliplatin dose is 610 to 680 mg/M2.
10) Confirmed the disease control; CR/PR/SD by each image after induction therapy.
11) Signed informed consent obtained before any study specific procedures. Patients must be able to understand and willing to sign a written informed consent.

Exclude criteria

1) Prior treatment with TAS-102 and Bevacizumab.
2) Previous or concurrent cancer that is distinct in primary site or histology form colorectal cancer within 1 years prior to EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta, Tis and T1].
3) Major surgical procedure within 28 days before start of study medication.
4) Pregnant or breast-feeding patients. Woman of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment, and a negative result must be documented before start of treatment.
5)Congestive heart failure >=NYHA class 2.
6) Unstable angina, new-onset angina. Myocardial infarction less than 6 months before start of study medication.
7)Uncontrolled hypertension.
8) Pleural effusion or ascites with dyspnea higher than CTCAE v4.0 grade 2.
9) Arterial or venous thrombotic or embolic events such as cerebrovascular accident, deep vein thrombosis or pulmonary embolism within the 6 months before start of study medication.
10) Known history of HIV infection, or chronic hepatitis B or C.
11) Symptomatic metastatic brain or meningeal metastasis.
12) Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event >= CTCAE v4.0 Grade 3 within 4 weeks of start of study medication.
13) Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
14) Persistant proteinuria of CTCAE v4.0 Grade 3 or higher.
15) Patients unable to swallow oral medications.
16) Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
17) Non-healing wound, ulcer, or bone fracture.
18) Unsolved toxicity higher than CTCAE v4.0 Grade 1 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neurotoxicity <= Grade 2.
19) A responsible doctor has confirmed the candidate should be excluded from this study.

Related Information

• Primary Sponsor: Uemura Mamoru
• Secondary ID(s): UMIN000031317