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Capecitabine as Radiosensitising Agent in Neoadjuvant Treatment of Locally Advanced Resectable Rectal Cancer

NCT ID: NCT01152710

Last Updated: 2010-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2010-04-30

Brief Summary

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A Phase II study aimed to evaluate the efficacy and toxicity of preoperative chemoradiotherapy with capecitabine in locally advanced resectable rectal cancer.

Detailed Description

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Preoperative chemoradiation has become a standard part of treatment protocols in stage II and III rectal cancer. Compared to postoperative chemoradiotherapy, the advantage of preoperative application of chemotherapeutics and irradiation includes improved compliance, reduced toxicity and downstaging of the tumour in a substantial number of patients. The latter may enhance the rate of curative surgery, permit sphincter preservation in patients with low-sited tumours and have a positive impact on the quality of life of these patients. Orally administered capecitabine (Xeloda®, Hoffmann - La Roche Ltd, Basel, Switzerland) mimics the pharmacokinetics of continuous 5-FU infusion and makes chemoradiotherapy more patient-friendly. The mechanism of capecitabine activation, preferably in tumour cells, may further enhance its efficacy and tolerability, offering the potential for an enhanced therapeutic ratio.The aim of the present phase II study was to evaluate the efficacy and toxicity of preoperative chemoradiotherapy with capecitabine in patients with locally advanced rectal cancer. The primary endpoint of the study is a pathologically determined complete remission rate (pCR) of the disease locally and regionally. Secondly, the rate of sphincter preservation in low-sited tumours, overall downstaging rate,toxicity and survival parameters will be analysed.

Conditions

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Resectable Rectal Cancer Clinical Stage II and III

Keywords

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capecitabine chemoradiation rectal cancer phase II study

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Capecitabine

Chemotherapy with capecitabine of 1650 mg/m2 daily dose will be administered orally, divided into two equal doses given 12 hours apart, during radiotherapy(45 Gy 1,8 Gy/fr), including weekends

Intervention Type DRUG

Other Intervention Names

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Xeloda

Eligibility Criteria

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Inclusion Criteria

* histologically verified adenocarcinoma of the rectum,
* resectable clinical stage II or III (IUCC TNM classification 2002);
* no prior radiotherapy and/or chemotherapy;
* World Health Organisation (WHO) performance status \< 2;
* age at diagnosis of 18 or older;
* and adequate bone marrow, liver, renal and cardiac function (no history of ischemic heart disease).

Exclusion Criteria

* A history of prior malignancy other than non-melanoma skin cancer or in situ carcinoma of the cervix
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Oncology Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Institute of Oncology

Locations

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Institute of Oncology

Ljubljana, Slovenia, Slovenia

Site Status

Countries

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Slovenia

References

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Sauer R, Becker H, Hohenberger W, Rodel C, Wittekind C, Fietkau R, Martus P, Tschmelitsch J, Hager E, Hess CF, Karstens JH, Liersch T, Schmidberger H, Raab R; German Rectal Cancer Study Group. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med. 2004 Oct 21;351(17):1731-40. doi: 10.1056/NEJMoa040694.

Reference Type BACKGROUND
PMID: 15496622 (View on PubMed)

Schuller J, Cassidy J, Dumont E, Roos B, Durston S, Banken L, Utoh M, Mori K, Weidekamm E, Reigner B. Preferential activation of capecitabine in tumor following oral administration to colorectal cancer patients. Cancer Chemother Pharmacol. 2000;45(4):291-7. doi: 10.1007/s002800050043.

Reference Type BACKGROUND
PMID: 10755317 (View on PubMed)

Kim JS, Kim JS, Cho MJ, Song KS, Yoon WH. Preoperative chemoradiation using oral capecitabine in locally advanced rectal cancer. Int J Radiat Oncol Biol Phys. 2002 Oct 1;54(2):403-8. doi: 10.1016/s0360-3016(02)02856-0.

Reference Type BACKGROUND
PMID: 12243814 (View on PubMed)

Twelves C, Boyer M, Findlay M, Cassidy J, Weitzel C, Barker C, Osterwalder B, Jamieson C, Hieke K; Xeloda Colorectal Cancer Study Group. Capecitabine (Xeloda) improves medical resource use compared with 5-fluorouracil plus leucovorin in a phase III trial conducted in patients with advanced colorectal carcinoma. Eur J Cancer. 2001 Mar;37(5):597-604. doi: 10.1016/s0959-8049(00)00444-5.

Reference Type BACKGROUND
PMID: 11290435 (View on PubMed)

Jansman FG, Postma MJ, van Hartskamp D, Willemse PH, Brouwers JR. Cost-benefit analysis of capecitabine versus 5-fluorouracil/leucovorin in the treatment of colorectal cancer in the Netherlands. Clin Ther. 2004 Apr;26(4):579-89. doi: 10.1016/s0149-2918(04)90060-4.

Reference Type BACKGROUND
PMID: 15189755 (View on PubMed)

Dunst J, Reese T, Sutter T, Zuhlke H, Hinke A, Kolling-Schlebusch K, Frings S. Phase I trial evaluating the concurrent combination of radiotherapy and capecitabine in rectal cancer. J Clin Oncol. 2002 Oct 1;20(19):3983-91. doi: 10.1200/JCO.2002.02.049.

Reference Type BACKGROUND
PMID: 12351595 (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)

Other Identifiers

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139/03/06

Identifier Type: -

Identifier Source: org_study_id