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

NCT01152710 | Completed Phase 2

• 1 other identifier: 139/03/06
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Resectable Rectal Cancer Clinical Stage II and III

Keywords

capecitabine; chemoradiation; rectal cancer; phase II study

Outcome Measures

Primary Outcomes (1)

• complete pathological remission rate

  after pathological examination of resected specimen

  9 weeks

Secondary Outcomes (7)

• the rate of sphincter preservation in low-sited tumours

  9 weeks

• toxicity of combined modality treatment (Number of Participants with Adverse Events)

  5 weeks

• overall downstaging rate

  9 weeks

• overall survival

  5 years

• local control

  5 years

Interventions

Capecitabine DRUG

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

Also known as: Xeloda

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• A history of prior malignancy other than non-melanoma skin cancer or in situ carcinoma of the cervix

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology

Ljubljana, Slovenia, 1000, Slovenia

Location

Related Publications (7)

• 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.

  PMID: 15496622 BACKGROUND

• 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.

  PMID: 10755317 BACKGROUND

• 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.

  PMID: 12243814 BACKGROUND

• 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.

  PMID: 11290435 BACKGROUND

• 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.

  PMID: 15189755 BACKGROUND

• 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.

  PMID: 12351595 BACKGROUND

• 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.

  PMID: 17042060 RESULT

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: June 29, 2010
• Study Start: June 1, 2004
• Primary Completion: March 1, 2006
• Study Completion: April 1, 2010
• Last Updated: June 29, 2010

Record last verified: 2010-06

Locations

SL (1)