Back to resultsIMRT-SIB and Capecitabine in Preoperative Rectal Cancer Treatment (BISER)
Primary Purpose
Rectal Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
Slovenia
Study Type
Interventional
Intervention
IMRT-SIB
Capecitabine
Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Carcinoma focused on measuring rectal carcinoma, preoperative radiochemotherapy, IMRT, SIB
Eligibility Criteria
Inclusion Criteria:
- Biopsy-proven newly diagnosed primary rectal adenocarcinoma
Locally advanced tumor fulfilling at least one of the following criteria on pelvic MRI:
- T ≥ 3 or
- N ≥ 1
- Positive mesorectal fascia (MRF), i.e. tumor or lymph node one mm or less from the mesorectal fascia
- Tumor located od 0 - 15 cm above anocutaneous junction or below peritoneum
- Age 18 years and more
- Signed informed consent
- WHO Performance Status 0-2
- Patients is considered to be mentally and physically ft for chemotherapy as judged by oncologist
- Adequate hematological, hepatic and renal function (WBC ≥ 3.0 x 109/L, neu ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, renal clearance ≥ 50 ml/min, bilirubin ≤ 3x normal value, aspartate transaminase/alanine transaminase (AST/ALT) ≤ 2,5x normal value)
Exclusion Criteria:
- T4 inoperable tumor - extensive growth into cranial part of the sacrum (above S3) or the lumbosacral nerve roots
- Metastatic or recurrent rectal cancer
- Other co-existing malignancy or malignancy within the past 5 years, with the exception of adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin
- Chronic bowel inflammatory disease
- Pregnant or lactating patient
- Significant heart disease (uncontrolled hypertension despite of medication (> 150/100 mmHg), New York Heart Association (NYHA) class III or IV heart disease,unstable angina or myocardial infarction within the past 1 year prior the study entry, history of significant ventricular arrhythmia requiring treatment)
- Inability to consciously sign the consent form due to physical or psychological disabilities
Sites / Locations
- Institute of OncologyRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
IMRT-SIB
Arm Description
Outcomes
Primary Outcome Measures
Pathological complete remission rate (pCR)
Secondary Outcome Measures
Toxicity
Histopathological R0 resection rate
Tumor down-staging rate
Rate of sphincter sparing surgical procedure
Loco-regional failure rate
Disease-free survival
Overall survival
Quality of life
Full Information
NCT ID
NCT02268006
First Posted
February 2, 2014
Last Updated
October 15, 2014
Sponsor
Institute of Oncology Ljubljana
1. Study Identification
Unique Protocol Identification Number
NCT02268006
Brief Title
IMRT-SIB and Capecitabine in Preoperative Rectal Cancer Treatment
Acronym
BISER
Official Title
Preoperative Radiochemotherapy With IMRT - Simultaneous Integrated Boost in Locally Advanced Rectal Cancer - BISER
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Oncology Ljubljana
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Using small radiation beamlets of different intensity, IMRT (intensity modulated radiation therapy) allows shaping the dose around planning target volume with better sparing of normal tissue comparing to 3D conformal radiotherapy. It allows daily delivery of higher dose to the tumor with simultaneous integrated boost (SIB), consequently shortening total treatment time with potentially better response to treatment. In advanced rectal adenocarcinoma excellent response to preoperative radiochemotherapy with complete eradication of the primary tumor observed in the histopathological specimen (pathological complete response, pCR) correlates with a favorable overall prognosis, so trying to achieve better response to preoperative treatment with higher pCR seams feasible.
PURPOSE:The hypothesis of this study is that in preoperative radiochemotherapy for locally advanced rectal adenocarcinoma shortening of the total treatment time with IMRT-SIB to 22 daily fractions concomitant with capecitabine results in an improved pCR rate from 9% (Slovenian trial) to 25%. Secondary objectives are to evaluate pathological down-staging rate, histopathological R0 resection rate, sphincter preservation rate, perioperative surgical complication rate, local control, disease-free survival (DFS), overall survival (OS), late toxicity and quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Carcinoma
Keywords
rectal carcinoma, preoperative radiochemotherapy, IMRT, SIB
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IMRT-SIB
Arm Type
Other
Intervention Type
Radiation
Intervention Name(s)
IMRT-SIB
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
(Xeloda, Capecitabine Teva, Ecansya)
Intervention Type
Procedure
Intervention Name(s)
Surgery
Other Intervention Name(s)
Total Mesorectal Exscision
Primary Outcome Measure Information:
Title
Pathological complete remission rate (pCR)
Time Frame
after the pathological examination of surgical specimens i.e. within 14 days after the operation
Secondary Outcome Measure Information:
Title
Toxicity
Time Frame
According to NCI-CTC (version 4.0): every week for 16 week preoperative, perioperative (0-30 days postoperative), early (30 days - 6 months postoperative), and late (more than 6 months postoperative)
Title
Histopathological R0 resection rate
Time Frame
after the pathological examination of resected specimens i.e. within 14 days after the operation
Title
Tumor down-staging rate
Time Frame
after the pathological examination of resected specimens i.e. within 14 days after the operation
Title
Rate of sphincter sparing surgical procedure
Time Frame
Toxicity/safety: one month after surgery.
Title
Loco-regional failure rate
Time Frame
after 3y and 5y of operation
Title
Disease-free survival
Time Frame
after 3y and 5y of operation
Title
Overall survival
Time Frame
after 3y and 5y of the operation
Title
Quality of life
Time Frame
before the treatment, after surgery, after1,2,3,4 and 5 years of the operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Biopsy-proven newly diagnosed primary rectal adenocarcinoma
Locally advanced tumor fulfilling at least one of the following criteria on pelvic MRI:
T ≥ 3 or
N ≥ 1
Positive mesorectal fascia (MRF), i.e. tumor or lymph node one mm or less from the mesorectal fascia
Tumor located od 0 - 15 cm above anocutaneous junction or below peritoneum
Age 18 years and more
Signed informed consent
WHO Performance Status 0-2
Patients is considered to be mentally and physically ft for chemotherapy as judged by oncologist
Adequate hematological, hepatic and renal function (WBC ≥ 3.0 x 109/L, neu ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, renal clearance ≥ 50 ml/min, bilirubin ≤ 3x normal value, aspartate transaminase/alanine transaminase (AST/ALT) ≤ 2,5x normal value)
Exclusion Criteria:
T4 inoperable tumor - extensive growth into cranial part of the sacrum (above S3) or the lumbosacral nerve roots
Metastatic or recurrent rectal cancer
Other co-existing malignancy or malignancy within the past 5 years, with the exception of adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin
Chronic bowel inflammatory disease
Pregnant or lactating patient
Significant heart disease (uncontrolled hypertension despite of medication (> 150/100 mmHg), New York Heart Association (NYHA) class III or IV heart disease,unstable angina or myocardial infarction within the past 1 year prior the study entry, history of significant ventricular arrhythmia requiring treatment)
Inability to consciously sign the consent form due to physical or psychological disabilities
Facility Information:
Facility Name
Institute of Oncology
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jasna But-Hadzic, MD
Phone
+38615879503
Email
jbut@onko-i.si
First Name & Middle Initial & Last Name & Degree
Vaneja Velenik, MD,PhD, asist. prof.
Phone
+38615879661
Email
vvelenik@onko-i.si
First Name & Middle Initial & Last Name & Degree
Jasna But-Hadzic, MD
First Name & Middle Initial & Last Name & Degree
Vaneja Velenik, MD,PhD,asist.prof.
First Name & Middle Initial & Last Name & Degree
Irena Oblak, MD,PhD,asist.prof.
First Name & Middle Initial & Last Name & Degree
Franc Anderluh, MD,MSc
First Name & Middle Initial & Last Name & Degree
Ajra Secerov, MD
First Name & Middle Initial & Last Name & Degree
Ibrahim Edhemovic, MD,MSc
First Name & Middle Initial & Last Name & Degree
Erik Brecelj, MD,PhD
First Name & Middle Initial & Last Name & Degree
Andrej Vogrin, MD
First Name & Middle Initial & Last Name & Degree
Rihard Hudej
First Name & Middle Initial & Last Name & Degree
Mirko Omejc, MD,PhD,prof.
First Name & Middle Initial & Last Name & Degree
Miran Koželj, MD
First Name & Middle Initial & Last Name & Degree
Bojan Krebs, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
19231097
Citation
Engels B, De Ridder M, Tournel K, Sermeus A, De Coninck P, Verellen D, Storme GA. Preoperative helical tomotherapy and megavoltage computed tomography for rectal cancer: impact on the irradiated volume of small bowel. Int J Radiat Oncol Biol Phys. 2009 Aug 1;74(5):1476-80. doi: 10.1016/j.ijrobp.2008.10.017. Epub 2009 Feb 21.
Results Reference
background
PubMed Identifier
20187944
Citation
Arbea L, Ramos LI, Martinez-Monge R, Moreno M, Aristu J. Intensity-modulated radiation therapy (IMRT) vs. 3D conformal radiotherapy (3DCRT) in locally advanced rectal cancer (LARC): dosimetric comparison and clinical implications. Radiat Oncol. 2010 Feb 26;5:17. doi: 10.1186/1748-717X-5-17.
Results Reference
background
PubMed Identifier
21651775
Citation
Mok H, Crane CH, Palmer MB, Briere TM, Beddar S, Delclos ME, Krishnan S, Das P. Intensity modulated radiation therapy (IMRT): differences in target volumes and improvement in clinically relevant doses to small bowel in rectal carcinoma. Radiat Oncol. 2011 Jun 8;6:63. doi: 10.1186/1748-717X-6-63.
Results Reference
background
PubMed Identifier
21903285
Citation
Li JL, Ji JF, Cai Y, Li XF, Li YH, Wu H, Xu B, Dou FY, Li ZY, Bu ZD, Wu AW, Tham IW. Preoperative concomitant boost intensity-modulated radiotherapy with oral capecitabine in locally advanced mid-low rectal cancer: a phase II trial. Radiother Oncol. 2012 Jan;102(1):4-9. doi: 10.1016/j.radonc.2011.07.030. Epub 2011 Sep 6.
Results Reference
background
PubMed Identifier
17042060
Citation
Velenik V, Anderluh F, Oblak I, Strojan P, Zakotnik B. Capecitabine as a radiosensitizing agent in neoadjuvant treatment of locally advanced resectable rectal cancer: prospective phase II trial. Croat Med J. 2006 Oct;47(5):693-700.
Results Reference
result
PubMed Identifier
20920276
Citation
Velenik V, Oblak I, Anderluh F. Long-term results from a randomized phase II trial of neoadjuvant combined-modality therapy for locally advanced rectal cancer. Radiat Oncol. 2010 Sep 29;5:88. doi: 10.1186/1748-717X-5-88.
Results Reference
result
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IMRT-SIB and Capecitabine in Preoperative Rectal Cancer Treatment
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