IMRT-SIB and Capecitabine in Preoperative Rectal Cancer Treatment

NCT ID: NCT02268006

Last Updated: 2014-10-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2020-12-31

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.

Conditions

Rectal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IMRT-SIB

Group Type: OTHER

IMRT-SIB

Intervention Type: RADIATION

Capecitabine

Intervention Type: DRUG

Surgery

Intervention Type: PROCEDURE

Interventions

IMRT-SIB

Intervention Type: RADIATION

Capecitabine

Intervention Type: DRUG

Surgery

Intervention Type: PROCEDURE

Other Intervention Names

(Xeloda, Capecitabine Teva, Ecansya); Total Mesorectal Exscision

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Oncology Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Oncology

Ljubljana, , Slovenia

Site Status: RECRUITING

Countries

Slovenia

Facility Contacts

Jasna But-Hadzic, MD

Role: primary

jbut@onko-i.si

+38615879503

Vaneja Velenik, MD,PhD, asist. prof.

Role: backup

vvelenik@onko-i.si

+38615879661

References

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.

Reference Type: BACKGROUND

PMID: 19231097 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20187944 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21651775 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21903285 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17042060 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20920276 (View on PubMed)

Other Identifiers

41/12/13

Identifier Type: -

Identifier Source: org_study_id