Phase II multicenter, double-blind, randomized controlled trial of FOLFOX therapy with bevacizumab in patients with unresectable advanced / recurrent small bowel cancer

JRCT ID: jRCT2031210656

Registered date:10/03/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: unresectable advanced / recurrent small bowel cancer
• Date of first enrollment: 30/05/2022
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Eligible cases are assigned to the Bev + FOLFOX group or the placebo + FOLFOX group. In principle, one cycle should be 14 days, and the investigational drug (bevacizumab or placebo) should be administered on Day 1 of mFOLFOX6. Bevacizumab is administered by mixing 5 mg / kg (body weight) into physiological saline at a time. Placebo is given 100 mL of saline. The frequency of administration of the investigational drug is not specified.

Outcome(s)

• Primary Outcome: Progression Free Survival (PFS)

Secondary Outcome

- PFS as of 1 year
- Overall survival (OS)
- Response rate
- Effective period
- Effect of reducing target lesions
- Disease control rate
- Resection rate
- Secondary cancer incidence rate
- Study treatment administration period
- Adverse event

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1) Histologically confirmed primary small intestine carcinoma
2) Judged to be unresectable due to infiltration of surrounding organs or distant metastasis
3) No history of chemotherapy or radiation therapy, except postoperative adjuvant chemotherapy as long as 6 months have passed since the termination at the time of allocation
4) ECOG Performance Status score of 0 or 1
5) The age of >=20, and <=80 at the time of consent
6) Having measurable lesions
7) Having sufficient organ function
i. Neutrophil count: 1,500 / micro Liter or more
ii. Platelet count: 10.0 x 10^4 / micro Liter or more
iii. Hemoglobin: 9.0 g / dL or more
iv. Total bilirubin: 1.5 mg / dL or less
v. AST, ALT: 100 IU / L (100U / L) or less for both (200 IU / L (200U / L) or less if you have liver metastasis)
vi. Serum creatinine: 1.5 mg / dL or less
8) Obtained written informed consent from the patient for participation in the clinical trial

Exclude criteria

1) Experienced active double cancer within 5 years
2) Having an active infection
4) Having fresh bleeding in the gastrointestinal tract
5a) Observed diarrhea that interferes with daily life
6) Having symptomatic brain metastases
8) With serious complications (intestinal palsy, interstitial pneumonia or pulmonary fibrosis, uncontrollable diabetes, heart failure, ischemic heart disease requiring treatment, uncontrolled hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg).
9) Those who are possibly pregnant, gave birth within 28 days, lactating, or unwilling to contraceptive
10) Judged that it is difficult to obtain informed consent due to mental illness
12a) Administered platelet aggregation inhibitors, vitamin K antagonists at therapeutic doses, or anticoagulant treatments at effective doses within 10 days prior to allocation
13) With a history of hemoptysis of 2.5 mL or more
14a) Having a high possibility for bleeding, such as tumor tissue involving major blood vessels
15a) With severe non-healing wounds, ulcers or fractures
16) Those who have experienced major surgery, with the wound not healed completely, or those whose surgery are scheduled within 28 days prior to allocation
17) Participating in other clinical trials
18) Others that the attending doctor judged inappropriate for this trial
* Missing numbers: 3), 7), 11), Corrections: 5a), 12a), 14a), 15a)

Related Information

• Primary Sponsor: Yamashita Haruhiro
• Source(s) of Monetary Support: Grant-in-Aid for Clinical Research from the National Hospital Organization