Induction Chemotherapy,Radiochemotherapy, Consolidation Chemotherapy in Preoperative Treatment of Rectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01489332
Recruitment Status : Unknown
Verified December 2011 by Institute of Oncology Ljubljana.
Recruitment status was:  Recruiting
First Posted : December 9, 2011
Last Update Posted : December 9, 2011
Information provided by (Responsible Party):
Institute of Oncology Ljubljana

Brief Summary:

The use of capecitabine based preoperative chemoradiation and adjuvant chemotherapy is standard treatment of locally advanced rectal cancer. It has reduced local recurrence rate to less than 10%, but has only had limited effect on overall survival due to the constantly high (more than 30%) rate of distant metastasis.

Complete eradication of the primary tumour observed in the histopathological specimen (pathological complete response, pCR) correlates with a favourable overall prognosis so obtaining a pCR might be beneficial. The aim of the study is to investigate whether the addition of capecitabine based chemotherapy before preoperative chemoradiation and also before the operation improves pathological complete remission rate in locally advanced rectal cancer with acceptable toxicity. Secondary objectives are to evaluate pathological downstaging rate, histopathological R0 resection rate,sphincter preservation rate, perioperative surgical complication rate, local control, DFS, OS, late toxicity and quality of life.

Condition or disease Intervention/treatment Phase
Rectal Cancer Drug: intensified preoperative chemotherapy Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Induction Chemotherapy, Preoperative Radiochemotherapy, Consolidation Chemotherapy, Operation and Adjuvant Chemotherapy in the Treatment of Locally Advanced Rectal Cancer- OIGIT 5-01 Phase II Trial
Study Start Date : October 2011
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : April 2018

Intervention Details:
  • Drug: intensified preoperative chemotherapy

    capecitabine 1250 mg/m² p.o. twice daily for 14 consecutive days, 7 days rest for one cycle; radiotherapy: 50.4 Gy to the pelvis (25x 1.8 Gy on days 1-33, excluding weekends) plus 5.4 Gy on days 36-38 as a boost to the primary tumour (3 fractions of 1.8 Gy).Three- dimensional CT planing and a four field box technique with high energy photons (15 MV) will be used. capecitabine 825 mg/m² p.o. twice daily on days 1-38 (including weekends), One week after completion of radiochemotherapy patients receive 2 cycles of capecitabine based chemotherapy (1250 mg/m² p.o. twice daily for 14 consecutive days every three weeks).

    Radical surgery (TME): to be undertaken 8 weeks following completion of chemoradiation Postoperative treatment:capecitabine 1250 mg/m² p.o. twice daily for 14 consecutive days every three weeks; 3 cycles (R0 beginning 6-8 weeks after surgery

Primary Outcome Measures :
  1. Pathological complete remission rate (pCR) [ Time Frame: after the pathological examination of surgical speciments ie within 14 days after the operation ]

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: According to NCI-CTC (version 3.0): every week for 16 week preoperative, perioperative (0-30 days postoperative), early (30 days - 6 months postoperative), and late (more than 6 months postoperative) ]
    Number of patients with adverse events and the grade of adverse events

  2. Histopathological R0 resection rate [ Time Frame: after the pathological examination of resected speciments ie within 14 days after the operation ]
  3. Loco-regional failure rate [ Time Frame: after 3y and 5y of operation ]
  4. Disease-free survival [ Time Frame: after 3y and 5y of operation ]
  5. Overall survival [ Time Frame: after 3y and 5y of the operation ]
  6. Quality of life [ Time Frame: before the treatment, after 1,and 3 years of the operation ]
    We will use EORTC questionnaires QLQ C30 and C38

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female patients with histologically proven adenocarcinoma of the rectum (tumour located below the peritoneum),
  • T3/4 or any node positive disease (clinical stage according the TNM classification system)
  • No evidence of metastatic disease.
  • The disease must be considered either resectable at the time of entry or thought to become resectable after preoperative chemoradiation.
  • Age 18 years and more
  • WHO Performance Status 0-2
  • No prior radiotherapy, chemotherapy or any targeting therapy for rectal cancer
  • Adequate hematological, hepatic and renal function Ability to swallow tablets
  • Signed informed consent
  • Patients must be willing and able to comply with the protocol for duration of the study

Exclusion Criteria:

  • Malignancy of the rectum other than adenocarcinoma
  • Any unrested synchronous colon 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
  • Significant heart disease (uncontrolled hypertension despite of medication (> 150/100 mmHg), 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)
  • Pregnant or lactating patient
  • Females with a positive or no pregnancy test unless childbearing potential can be otherwise excluded (amenorrheic for at least 2 years,hysterectomy or oophorectomy)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01489332

Contact: Vaneja Velenik, Prof.assist +386 1 5879297
Contact: Franc Anderluh, MD +386 1 5879297 fanderluh@onko/

Institute of Oncology Recruiting
Ljubljana, Slovenia, 1000
Contact: Vaneja Velenik, Prof.assist    +386 1 5879297    vvelenik@onko/   
Contact: Franc Anderluh, MD    +386 1 5879297    fanderluh@onko/   
Principal Investigator: Vaneja Velenik, Prof.assist         
Sub-Investigator: Irena Oblak, Prof.assist         
Sub-Investigator: Franc Anderluh, MD         
Sub-Investigator: Marija Skoblar Vidmar, MD         
Sub-Investigator: Ajra Secerov Ermenc, MD         
Sub-Investigator: Danijela Golo, MD         
Sub-Investigator: Ibrahim Edhemovic, MD         
Sub-Investigator: Erik Brecelj, PhD, MD         
Sub-Investigator: Mirko Omejc, Prof         
Sub-Investigator: Bojan Krebs, MD         
Sponsors and Collaborators
Institute of Oncology Ljubljana
Principal Investigator: Vaneja Velenik, Prof.assist Institute of Oncology Ljubljana, Slovenia


Responsible Party: Institute of Oncology Ljubljana Identifier: NCT01489332     History of Changes
Other Study ID Numbers: 163/06/11
First Posted: December 9, 2011    Key Record Dates
Last Update Posted: December 9, 2011
Last Verified: December 2011

Keywords provided by Institute of Oncology Ljubljana:
rectal cancer
locally advanced rectal cancer

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents