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Rectal CarcinomaPhase 2BISERNCT02268006

IMRT-SIB and Capecitabine in Preoperative Rectal Cancer Treatment

A Phase 2 study testing IMRT-SIB, Capecitabine and Surgery in people with Rectal Carcinoma, run by Institute of Oncology Ljubljana at 1 site in Slovenia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Rectal Carcinoma
What is being tested?
IMRT-SIB, Capecitabine and Surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSlovenia
Study dates
Jan 2014to Dec 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Slovenia1 site, 1 recruiting

  • Institute of Oncology

    Ljubljana, 1000

    Jasna But-Hadzic, MD, +38615879503, jbut@onko-i.si

    Vaneja Velenik, MD,PhD, asist. prof., +38615879661, vvelenik@onko-i.si

    Recruiting

Other trials in Slovenia

About this study

Official title: Preoperative Radiochemotherapy With IMRT - Simultaneous Integrated Boost in Locally Advanced Rectal Cancer - BISER

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.

Being tested
IMRT-SIB, Capecitabine, Surgery
Keywords
rectal carcinoma, preoperative radiochemotherapy, IMRT, SIB
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMRT-SIBRadiation

  • CapecitabineDrug

    Also called (Xeloda, Capecitabine Teva, Ecansya)

  • SurgeryProcedure or surgery

    Also called Total Mesorectal Exscision

Study groups in NCT02268006
Study groupRoleWhat they receive
IMRT-SIBOtherNot described
Receives: Radiation: IMRT-SIB; Drug: Capecitabine; Procedure: Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological complete remission rate (pCR)

    Measured: after the pathological examination of surgical specimens i.e. within 14 days after the operation

Secondary outcomes (8)

  1. Toxicity

    Measured: 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)

  2. Histopathological R0 resection rate

    Measured: after the pathological examination of resected specimens i.e. within 14 days after the operation

  3. Tumor down-staging rate

    Measured: after the pathological examination of resected specimens i.e. within 14 days after the operation

  4. Rate of sphincter sparing surgical procedure

    Measured: Toxicity/safety: one month after surgery.

  5. Loco-regional failure rate

    Measured: after 3y and 5y of operation

  6. Disease-free survival

    Measured: after 3y and 5y of operation

  7. Overall survival

    Measured: after 3y and 5y of the operation

  8. Quality of life

    Measured: before the treatment, after surgery, after1,2,3,4 and 5 years of the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionDec 2015 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02268006
Sponsor's protocol ID
41/12/13
Acronym
BISER
Status last verified
Sep 2014
First submitted
2 Feb 2014
Last updated
20 Oct 2014
Results posted
No

Publications

  • 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.

    PubMed 19231097

  • 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.

    PubMed 20187944

  • 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.

    PubMed 21651775

  • 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.

    PubMed 21903285

  • 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.

    PubMed 17042060

  • 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.

    PubMed 20920276

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IMRT-SIB, Capecitabine and Surgery in people with Rectal Carcinoma, run by Institute of Oncology Ljubljana at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete remission rate (pCR) (time frame: after the pathological examination of surgical specimens i.e. within 14 days after the operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02268006, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2014.

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