Status unknownNCT02268006BISERUpdated Oct 20, 2014

IMRT-SIB and Capecitabine in Preoperative Rectal Cancer Treatment

A Phase 2 interventional study of IMRT-SIB and Capecitabine in Rectal Carcinoma, sponsored by Institute of Oncology Ljubljana. Status unknown at 1 site in Slovenia. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2014-10-20.

Sponsored by Institute of Oncology Ljubljana · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2014), so the status shown — last known as Recruiting — may be out of date.

Phase: Phase 2
Study type: Interventional
Enrollment: 50
Allocation: Not applicable
Ages: 18 Years to 90 Years
Sex: All

Study 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.

Conditions studied

Rectal Carcinoma

Browse trials for

Rectal Neoplasms 1,762

Keywords

rectal carcinoma
preoperative radiochemotherapy
IMRT
SIB

In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's planned enrollment of 50 is below the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Institute of Oncology Ljubljana is the lead sponsor of 88 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 90 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 50 participants (estimated)

Study arms

Other
IMRT-SIB
Radiation: IMRT-SIB · Drug: Capecitabine · Procedure: Surgery

Interventions

RadiationIMRT-SIB
DrugCapecitabine
Also known as: (Xeloda, Capecitabine Teva, Ecansya)
ProcedureSurgery
Also known as: Total Mesorectal Exscision

What researchers measure

Primary outcomes

Pathological complete remission rate (pCR)
Time frame: after the pathological examination of surgical specimens i.e. within 14 days after the operation

Secondary outcomes

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)
Histopathological R0 resection rate
Time frame: after the pathological examination of resected specimens i.e. within 14 days after the operation
Tumor down-staging rate
Time frame: after the pathological examination of resected specimens i.e. within 14 days after the operation
Rate of sphincter sparing surgical procedure
Time frame: Toxicity/safety: one month after surgery.
Loco-regional failure rate
Time frame: after 3y and 5y of operation
Disease-free survival
Time frame: after 3y and 5y of operation
Overall survival
Time frame: after 3y and 5y of the operation
Quality of life
Time frame: before the treatment, after surgery, after1,2,3,4 and 5 years of the operation

Study locations

1 of 1 sites recruiting

Institute of Oncology
Ljubljana, 1000, Slovenia
- Jasna But-Hadzic, MD · Contact · jbut@onko-i.si · +38615879503
- Vaneja Velenik, MD,PhD, asist. prof. · Contact · vvelenik@onko-i.si · +38615879661
- Jasna But-Hadzic, MD · Principal investigator
- Vaneja Velenik, MD,PhD,asist.prof. · Sub investigator
- Irena Oblak, MD,PhD,asist.prof. · Sub investigator
- Franc Anderluh, MD,MSc · Sub investigator
- Ajra Secerov, MD · Sub investigator
- Ibrahim Edhemovic, MD,MSc · Sub investigator
- Erik Brecelj, MD,PhD · Sub investigator
- Andrej Vogrin, MD · Sub investigator
- Rihard Hudej · Sub investigator
- Mirko Omejc, MD,PhD,prof. · Sub investigator
- Miran Koželj, MD · Sub investigator
- Bojan Krebs, MD · Sub investigator
Recruiting

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02268006
Lead sponsor: Institute of Oncology Ljubljana
Responsible party: Sponsor
First posted: Oct 20, 2014
Start date: Jan 2014
Primary completion: Dec 2015 (estimated)
Completion: Dec 2020 (estimated)
Last update: Oct 20, 2014

View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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