EUCTR2015-002773-38-AT进行中（未招募）1 期
mFOLFOX6 vs. mFOLFOX6 + aflibercept as neoadjuvant treatment in MRI-defined T3-rectal cancer: a randomized phase-II-trial - AIO-KRK-0214 Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 119
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age = 18 years on day of signing informed consent
- •2. Signed and dated informed consent, and willing and able to comply with protocol requirements
- •3. WHO/ECOG Performance Status (PS) 0-1
- •4. Diagnosis of rectal adenocarcinoma
- •5. Candidate for sphincter-sparing surgical resection prior to neoadjuvant therapy according to the primary surgeon, i.e. no patient will be included for whom surgeon indicates need for abdomino-perineal resection (APR) at baseline.
- •6. Clinical staging is based on the combination of the following assessments:
- •Physical examination by the primary surgeon
- •CT scan of the chest/abdomen
- •Pelvic MRI
- •Rigid rectoscopy / endoscopic ultrasound (ERUS).
- •Both examinations (MRI + ERUS) are mandatory.
- •7. The tumor has to fulfill the following criteria:
- •No symptomatic bowel obstruction
- •Locally advanced rectal and rectosigmoid cancer, i.e. lower border of tumor > 5 cm and < 16 cm from anal verge as determined by rigid rectoscopy
- •MRI criteria:
- •a. Lower border of tumor below a line defined by promontorium and symphysis, regardless of the criterion < 16 cm from anal verge as determined by rigid rectoscopy”.
- •b. No evidence that tumor is adjacent to (defined as within 2 mm of) the mesorectal fascia on MRI (i.e. CRM > 2 mm)
- •c. Only T3-tumors are included, i.e infiltration into perirectal fat < 10 mm provided CRM > 2 mm
- •d. Note: MRI criteria are used for the definition of T3 tumor (i.e. exclusion of T2 and T4 situation).
- •8. Hematological status:
- •Neutrophils (ANC) = 2 x 10^9/L
- •Platelets = 100 x 10^9/L
- •Hemoglobin = 9 g/dL (previous transfusion of packed blood cells allowed)
- •9. Adequate renal function:
- •Serum creatinine level = 1.5 x upper limit normal (ULN) or = 1.5 mg/dl
- •Creatinine clearance = 30 ml/min
- •10. Adequate liver function:
- •Serum bilirubin = 1.5 x upper limit normal (ULN)
- •Alkaline phosphatase < 3 x ULN
- •AST and ALT < 3 x ULN
- •11. Proteinuria < 2+ (dipstick urinalysis) or = 1 g/24hour or = 500 mg/dl
- •12. Regular follow-up feasible
- •13. For female patients of childbearing potential, negative pregnancy test within 1 week (7 Days) prior of starting study treatment
- •14. Female patients of childbearing potential (i.e. did not undergo surgical sterilization – hysterectomy, bilateral tubal ligation, or bilateral oophorectomy - and is not post-menopausal for at least 24 consecutive months) must commit to using highly effective and appropriate methods of contraception until at least 6 months after the end of study treatment such as combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), vasectomized partner, bilateral tubal occlusion, sexual abstinence. If an oral contraception is used, a barrier method of contraception (e.g. male condom, female condom, cervical cap, diaphragm, contraceptive sponge) has to be applied additionally.
- •15. Fertile male patients with a partner of childbearing potential must commit to using highly effective and appropriate methods of contraception (details see above) until at least 9 months after the end of study treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 59
排除标准
- •1. Distant metastases (CT scans of thorax and abdomen are mandatory)
- •2. cT2 and cT4 tumors (defined by MRI criteria)
- •3. Exclusion of potentially compromised CRM as defined by MRI criteria (i.e. > 2 mm distance from CRM)
- •4. Prior antineoplastic therapy for rectal cancer
- •5. History or evidence upon physical examination of CNS metastasis
- •6. Uncontrolled hypercalcemia
- •7. Pre-existing permanent neuropathy (NCI-CTCAE grade = 2)
- •8. Uncontrolled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy
- •9. Concomitant protocol unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy, radiotherapy)
- •10. Treatment with any other investigational medicinal product within 28 days prior to study entry
- •11. Known dihydropyrimidine dehydrogenase (DPD) deficiency
- •12. Treatment with CYP3A4 inducers unless discontinued > 7 Days prior to randomization
- •13. Any of the following in 3 months prior to inclusion:
- •Grade 3-4 gastrointestinal bleeding
- •Treatment resistant peptic ulcer disease
- •Erosive esophagitis or gastritis
- •Infectious or inflammatory bowel disease
- •Diverticulitis
- •14. Any active infection within 2 weeks prior to study inclusion
- •15. Vaccination with a live, attenuated vaccine within 4 weeks prior to the first administration of the study medication
- •16. Other concomitant or previous malignancy, except:
- •Adequately treated in-situ carcinoma of the uterine cervix
- •Basal or squamous cell carcinoma of the skin
- •Cancer in complete remission for > 5 years
- •17. Any other serious and uncontrolled non-malignant disease, major surgery or traumatic injury within the last 28 days prior to study entry
- •18. Pregnant or breastfeeding women
- •19. Patients with known allergy to any constituent to study drugs
- •20. History of myocardial infarction and/or stroke within 6 months prior to randomization, NYHA class III and IV congestive heart failure
- •21. Severe renal insufficiency (creatinin clearance < 30 ml/min)
- •22. Bowel obstruction
- •23. Contra-indication to the assessment by MRI
- •24. Involvement in the planning and/or conduct of the study (applies to both Sanofi staff and/or staff of Sponsor and study site)
- •25. Patient who might be dependent on the sponsor, site or the investigator
- •26. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 AMG.
- •27. Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].
研究者
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