Capecitabine in the Perioperative Treatment of Rectal Cancer

NCT01500993 | Completed Phase 3

• 1 other identifier: Rektum III
• Study Type: interventional
• Target: 401
• Locations: 1 country
• Sites: 14

Brief Summary

This study compares capecitabine with standard 5-FU in the perioperative treatment of locally advanced rectal cancer.

Conditions

Rectal Cancer

Keywords

Rectal cancer; Chemoradiotherapy; Capecitabine; phase-III trial

Outcome Measures

Primary Outcomes (1)

• Overall survival

  5-year

Secondary Outcomes (2)

• disease-free survival (DFS)

  3-year DFS

• Local recurrence rate

  5 years

Study Arms (2)

5-Fluorouracil (5-FU)

ACTIVE COMPARATOR

Drug - 5FU based chemoradiotherapy and chemotherapy

Drug: 5-FU

Capecitabine

EXPERIMENTAL

Drug - Capecitabine-based radiochemotherapy and chemotherapy

Drug: Capecitabine

Interventions

Capecitabine DRUG

Capecitabine standard therapy (i.e. 2,500 mg/sqm) x 5 cycles plus 1 cycle of capecitabine based chemoradiotherapy (1.650 mg/sqm)

Also known as: Xeloda

Capecitabine

5-FU DRUG

4 cycles of bolus 5-FU (500 mg/sqm) and 1 cycle of 5-FU based chemoradiotherapy (either 1,000 mg/sqm/day infusional 5-Fu days 1-5 and 29-33 or 225 mg/sqm/day infusional 5-Fu throughout the time of chemoradiotherapy)

Also known as: 5-Fluorouracil

5-Fluorouracil (5-FU)

Eligibility Criteria

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

You may qualify if:

• Eligible patients are 18 years or older and have histologically confirmed adenocarcinoma of the rectum (defined as the distal border of the tumour less than 16 cm from the anal verge measured by rigid rectoscopy) with no evidence of distant metastases (identified by abdominal ultrasound or CT scan and chest radiography).
• Patients in the adjuvant cohort have undergone R0-resection by total mesorectal excision (TME) of a pT3-4 N any or T any N positive non-metastatic rectal cancer.
• Patients treated in the neoadjuvant cohort need to have a clinical T3-4 N any or T any N positive tumour staged by endoscopic ultrasound, provided the lower border of the tumour is located 0 - 16 cm from the anal verge measured by rigid rectoscopy and the primary tumour is deemed resectable by TME surgery on the basis of clinical assessment. Other eligibility criteria comprise: WHO status of zero or one; adequate liver, renal, and bone marrow function defined as follows: leucocyte count \> 3,500/µl, thrombocyte count \> 100,000/µl, hemoglobin \> 10.0 g/dl; serum bilirubin \< 2.0 mg/dl, serum creatinine \< 2.0 mg/dl.

You may not qualify if:

• Prior treatment for rectal cancer, prior chemo- or immunotherapy, prior pelvic radiotherapy, or a history of other malignant diseases within the past five years with the exception of successfully treated basal carcinoma of the skin or carcinoma in situ of the uterine cervix.

Sponsors & Collaborators

• Universitätsmedizin Mannheim: lead

Study Sites (14)

Dr Martina Grunewald

Aschersleben, Germany

Location

Dr Hans Walter Lindemann

Hagen, Germany

Location

Prof Hartmut Link

Kaiserslautern, Germany

Location

Dr Elisabeth Fritz

Koblenz, Germany

Location

Dr Stephan Kremers

Lebach, Germany

Location

Dr Lothar Müller

Leer, Germany

Location

Dr Christain Constantin

Lemgo, Germany

Location

Dr Erika Kettner

Magdeburg, Germany

Location

Dr Markus Moehler

Mainz, Germany

Location

Dr Udo Hieber

Mannheim, Germany

Location

Prof Ralf Hofheinz

Mannheim, Germany

Location

Dr Matthias Hipp

Regensburg, Germany

Location

Prof Axel Matzdorff

Saarbrücken, Germany

Location

Dr Stephan Laechelt

Tübingen, Germany

Location

Related Publications (2)

• Hofheinz RD, Wenz F, Post S, Matzdorff A, Laechelt S, Hartmann JT, Muller L, Link H, Moehler M, Kettner E, Fritz E, Hieber U, Lindemann HW, Grunewald M, Kremers S, Constantin C, Hipp M, Hartung G, Gencer D, Kienle P, Burkholder I, Hochhaus A. Chemoradiotherapy with capecitabine versus fluorouracil for locally advanced rectal cancer: a randomised, multicentre, non-inferiority, phase 3 trial. Lancet Oncol. 2012 Jun;13(6):579-88. doi: 10.1016/S1470-2045(12)70116-X. Epub 2012 Apr 13.

  PMID: 22503032 RESULT

• Garcia-Albeniz X, Gallego R, Hofheinz RD, Fernandez-Esparrach G, Ayuso-Colella JR, Bombi JA, Conill C, Cuatrecasas M, Delgado S, Gines A, Miquel R, Pages M, Pineda E, Pereira V, Sosa A, Reig O, Victoria I, Feliz L, Maria de Lacy A, Castells A, Burkholder I, Hochhaus A, Maurel J. Adjuvant therapy sparing in rectal cancer achieving complete response after chemoradiation. World J Gastroenterol. 2014 Nov 14;20(42):15820-9. doi: 10.3748/wjg.v20.i42.15820.

  PMID: 25400468 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Capecitabine; Fluorouracil

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; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Ralf Hofheinz, MD

  Universitätsmedizin Mannheim Germany, University of Heidelberg

  STUDY CHAIR

• Frederik Wenz, MD

  Universitätsmedizin Mannheim, Germany, University of Heidelberg

  STUDY CHAIR

• Stefan Post, MD

  Universitätsmedizin Mannheim, Germany, University of Heidelberg

  STUDY CHAIR

• Andreas Hochhaus, MD

  Universitätsklinikum Jena, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator, Head Department of Radiation Oncology Mannheim

Study Record Dates

• First Submitted: December 21, 2011
• First Posted: December 29, 2011
• Study Start: March 1, 2002
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: November 27, 2020

Record last verified: 2020-11

Locations

DE (14)