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Trial record 45 of 1544 for:    rectal cancer

Folfoxiri Plus Bevacizumab Followed by Chemoradiotherapy Plus Bevacizumab in Patients With Resectable Rectal Cancer (TRUST)

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ClinicalTrials.gov Identifier: NCT03085992
Recruitment Status : Completed
First Posted : March 22, 2017
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Alfredo Falcone, Azienda Ospedaliero, Universitaria Pisana

Brief Summary:
This study includes patients affected by advanced and resectable rectal adenocarcinoma. It provides an induction chemotherapy with FOLFOXIRI regimen plus Bevacizumab followed by Chemoradiotherapy plus Bevacizumab. Surgery with total mesorectal incision must be performed within 7-9 weeks after this last treatment. The protocol will be evaluate the disease free survival at two years. Translational analyses will be performed to show the presence of VEGF polymorphism, CD133 surface markers on colorectal CSCs.

Condition or disease Intervention/treatment Phase
Rectal Cancer Drug: FOLFOXIRI plus Bevacizumab Other: Chemoradiotherapy plus Bevacizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Phase II Study of Induction Treatment With Folfoxiri Plus Bevacizumab Followed by Preoperative Chemoradiotherapy Plus Bevacizumab in Patients With Locally Advanced, Resectable Rectal Cancer.
Study Start Date : March 2012
Actual Primary Completion Date : July 2017
Actual Study Completion Date : March 12, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: Single Arm
INDUCTION TREATMENT WITH FOLFOXIRI PLUS BEVACIZUMAB FOLLOWED BY PREOPERATIVE CHEMORADIOTHERAPY PLUS BEVACIZUMAB
Drug: FOLFOXIRI plus Bevacizumab
  • BEVACIZUMAB 5 mg/kg over 30 minutes, day 1
  • IRINOTECAN 165 mg/sqm IV over 1-h, day 1
  • OXALIPLATIN 85 mg/sqm IV over 2-h, day 1
  • L-LEUCOVORIN 200 mg/sqm IV over 2-h, day 1
  • 5-FLUOROURACIL 3200 mg/sqm IV 48-h continuous infusion, starting on day 1 administered every two weeks for 6 cycles (3 months).

Other: Chemoradiotherapy plus Bevacizumab
  • FLUOROURACIL 225 mg/sqm/day by protracted IV continuous infusion or -CAPECITABINE 825 mg/sqm/bid p.o. continuously without interruption for all the duration of radiation treatment;
  • EXTERNAL-BEAM IRRADIATION 50.4 GY in 28 daily fractions over 5.5 weeks;
  • BEVACIZUMAB 5 mg/kg over 30 minutes, starting on day 1 of radiation treatment day 1 and then every two weeks (for 3 cycles).




Primary Outcome Measures :
  1. Disease-free survival rate at 2 years [ Time Frame: Up to 2 years ]
    Disease-free survival is defined as time from study entry until progression of disease (according to RECIST 1.1) or death from any cause. Patients who are alive without having progressed at the end of the study will be censored at their last radiological assessment.


Secondary Outcome Measures :
  1. Response rate [ Time Frame: Up to 2 years ]
    Response rate is defined as the fraction of treated patients who achieve a response as defined according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria vers. 1.1.

  2. Toxicity Rate [ Time Frame: Up to 2 years ]
    Toxicity Rate is defined as the percentage of patients, relative to the total of enrolled subjects, experiencing treatment-related adverse events as assessed by National Cancer Institute Common Toxicity Criteria (version 3.0), during induction and concomitant chemoradiotherapy

  3. Overall survival [ Time Frame: Up to 2 years ]
    Overall survival is defined as the time from study entry until death from any cause. Patients who are alive at the end of the study will be censored at that point.

  4. Pathological complete response rate [ Time Frame: Up to 2 years ]
    Pathological complete response rate is defined as the fraction of treated patients who achieve pathological response after treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven diagnosis of rectal adenocarcinoma. Diagnosis obtained by a biopsy technique which leaves the major portion of the tumor intact.
  • Locally advanced, resectable disease defined by the presence of at least one of the following features: tumour extending to within 1 mm of or beyond the mesorectal fascia (ie, circumferential radial margin threatened or involved); lower third (≤ 6 cm from the anal verge) cT3 tumours; tumour extending 5 mm or more into perirectal fat; T4 tumour (ie, invading surrounding structures or peritoneum); clinical stage III disease (T1-4, N1-2), with the definition of a clinically positive lymph node being any node ≥ 1.0 cm;
  • Distal border of the tumor must be located < 12 cm from the anal verge.
  • No evidence of metastatic disease by CT scan of the chest and abdomen and total body PET-CT scan.
  • Tumor must be amenable to curative resection (curative resection can include pelvic exenteration).
  • No history of invasive rectal malignancy, regardless of disease-free interval.
  • No other rectal cancers (i.e., sarcoma, lymphoma, carcinoid, squamous cell carcinoma, or cloacogenic carcinoma) or synchronous colon cancer.
  • No clear indication of involvement of the pelvic side walls by imaging.
  • Age between 18 and 75 years.
  • ECOG Performance status < 2 if age < 70 years and = 0 if age 71-75 years.
  • Life expectancy of at least 5 years (excluding diagnosis of cancer).
  • Hematopoietic: absolute neutrophil count ≥ 1,000/mm3; platelet count ≥ 100,000/mm3; haemoglobin level ≥ 10 g/dL.
  • Hepatic: total bilirubin ≤ 1.5 times upper limit of normal (ULN); alkaline phosphatase ≤ 2 times ULN; AST ≤ 2 times ULN. [Note: *If AST>ULN, serologic testing for Hepatitis B and C must be negative].
  • Renal: creatinine clearance > 50 mL/min; no renal disease that would preclude study treatment or follow-up.
  • Written informed consent to experimental treatment and pharmacogenomic analyses.

Exclusion Criteria:

  • Previous treatment with oxaliplatin, irinotecan or bevacizumab. Previous 5-fluorouracil or capecitabine treatment is allowed.
  • Previous pelvic radiation therapy.
  • Hepatic disease that would preclude study treatment or follow-up; uncontrolled coagulopathy; history of viral hepatitis or other chronic liver disease.
  • Cardiovascular disease that would preclude study treatment or follow-up; New York Heart Association class III or IV heart disease; active ischemic heart disease; myocardial infarction within the past 6 months; symptomatic arrhythmia; uncontrolled hypertension.
  • Lack of upper gastrointestinal tract integrity or malabsorption syndrome; active inflammatory bowel disease (i.e., patients requiring current medical interventions or who are symptomatic).
  • Pregnant or lactating women. Fertile patients must use effective contraception (i.e double-barrier contraceptive measures, oral contraception or avoidance of intercourse during the study and for 30 days after surgery).
  • Patients with prior malignancies (with the exception of rectal cancer), including invasive colon cancer, are eligible provided they have been disease-free for ≥ 5 years and are deemed by their physician to be at low risk for recurrence.
  • Other malignancy within the past 5 years with the exception of effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum.
  • Known hypersensitivity to fluorouracil, oxaliplatin or irinotecan or to Chinese hamster ovary cell proteins.
  • Clinically significant peripheral neuropathy (i.e., neurosensory or neuromotor toxicity ≥ grade 2).
  • Psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03085992


Locations
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Italy
Irccs Istituto Oncologico Veneto
Padova, Italy, 35128
Polo Oncologico Area Vasta Nord Ovest
Pisa, Italy, 56100
ausl5 di Pisa
Pontedera, Italy, 56100
Dipartimento Oncologico AUSL 7
Siena, Italy, 53100
Sponsors and Collaborators
Azienda Ospedaliero, Universitaria Pisana
Investigators
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Principal Investigator: Alfredo Falcone, MD Polo Oncologico Area Vasta Nord Ovest

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Responsible Party: Alfredo Falcone, Prof., Azienda Ospedaliero, Universitaria Pisana
ClinicalTrials.gov Identifier: NCT03085992     History of Changes
Other Study ID Numbers: TRUST
2011-003340-45 ( EudraCT Number )
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Alfredo Falcone, Azienda Ospedaliero, Universitaria Pisana:
rectal cancer
FOLFOXIRI
bevacizumab
trust
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Rectal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors