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Preoperative Chemoradiotheray for Rectal Cancer

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ClinicalTrials.gov Identifier: NCT00819559
Recruitment Status : Unknown
Verified January 2009 by Korean Rectal Cancer Study Group.
Recruitment status was:  Not yet recruiting
First Posted : January 9, 2009
Last Update Posted : January 12, 2009
Sponsor:
Information provided by:
Korean Rectal Cancer Study Group

Tracking Information
First Submitted Date  ICMJE January 7, 2009
First Posted Date  ICMJE January 9, 2009
Last Update Posted Date January 12, 2009
Study Start Date  ICMJE March 2009
Estimated Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2009)
Disease-free survival [ Time Frame: 5 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00819559 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2009)
Overall survival Local recurrence Early or late complication associated with preoperative radiotherapy Quality of life Accuracy of clinical staging Difference of surgical outcome between laparoscopic and open surgery [ Time Frame: Up to 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preoperative Chemoradiotheray for Rectal Cancer
Official Title  ICMJE Role of Preoperative Chemoradiotherapy in Clinically T3No Mid and Low Rectal Cancer : Multi-Institute Clinical Study
Brief Summary

Hypothesis

  • Pre operative radio-chemotherapy might be not mandatory to improve local recurrent rate and survival rate in the mid-lower rectal cancer patients with T3N0 clinical stage, if surgical principals were kept.
  • Laparoscopic resection is not inferior to Open surgery in the treatment of rectal cancer.
Detailed Description It is known that 20-60% of the rectal cancer patients treated with radical resection have the local recurrence. Therefore, chemo-radiotherapy before or after operation have been the standard treatment protocol in the rectal cancer patients to reduce the local recurrence, preserve more surrounding pelvic viscera, improve the prognosis and eventually quality of life. The preoperative chemo-radiotherapy was introduced by the German Rectal Cancer study, which compared pre- and postoperative chemo and radiotherapy. In this study, the authors reported that preoperative chemo-radiotherapy reduced local recurrent rate and 3 or 4 degree toxicity and improved the compliance for treatment. Since the introduction of chemo and radiotherapy in the treatment of rectal cancer, there have been numerous controversies on the guidelines or protocols of chemo-radiotherapy. In 1990, National Institute of Health (NIH) recommended postoperative chemo- radiotherapy to all the pT3 or pN1 rectal cancer patients at the consensus conference. In some studies, they reported that good clinical outcome and low local recurrence rate were obtained by only surgical treatment in the pT3N0 rectal cancer patients with favourable pathological characteristics. They also insisted that the effectiveness of postoperative chemo- radiotherapy was not evident. Gunderson, et al. retrospectively evaluated the five-year survival rate of the pT3N0 patients. They reported that the patients with surgery and chemotherapy showed the similar survival rate with the patients who underwent surgery and postoperative chemo-radiotherapy. National Cancer Data Base showed the similar report. However, there are some problems to apply theses results to the decision of preoperative therapeutic options. Moreover, some papers showed the low local recurrent rate (less than 5%) in the stage II without the supplement therapy, when the TME was precisely performed. All these results present the controversies on the radio-chemotherapy on all the T3N0 patients in terms of the clinical outcomes and the prognosis. In Korea, numerous clinical trials have been performed on the rectal cancer patients, however there has been no clinical study for preoperative chemo- radiotherapy in the T3N0 rectal cancer patients. In this reason, the protocols are different among institutions without unified standard treatment protocol. In this study, the authors compare the accuracy of diagnosis, the functional differences according to the preoperative chemo- radiotherapy, the local recurrent rate and survival rate between the two groups of T3N0 patients; one group with preoperative chemo-radiotherapy vs. the other without. In addition, the authors evaluate the advantage of the laparoscopic surgery, such as an extensive vision, so that laparoscopy can help rectal surgery as well as the surgical outcome.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rectal Neoplasm
Intervention  ICMJE Radiation: PCRT
Preoperative chemoradiotherapy
Other Name: preoperative chemoradiotherapy
Study Arms  ICMJE
  • Active Comparator: Open PCRT group
    Patients who underwent preoperative chemoradiotherapy and open resection
    Intervention: Radiation: PCRT
  • Experimental: Open no PCRT group
    Patients who did not undergo preoperative chemoradiotherapy and open resection
    Intervention: Radiation: PCRT
  • Active Comparator: LAP PCRT group
    Patients who underwent preoperative chemoradiotherapy and laparoscopic resection
    Intervention: Radiation: PCRT
  • Experimental: LAP no PCRT group
    Patients who did not undergo preoperative chemoradiotherapy and laparoscopic resection
    Intervention: Radiation: PCRT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 7, 2009)
1160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically demonstrated and cytologically evident rectal cancer (Glandular carcinoma: located on 4-12cm from anus), the case without remote metastasis
  • Age: 18-70 years old
  • The patients who did not undergo radiation therapy, surgery or antitumor agent therapy with the same disease medical history
  • The patients with clinical stage of T3N0 identified by ultrasound or MRI
  • Appropriate bone marrow, liver and renal function as follow; granulocyte ≥ 1500, platelet ≥ 80,000, bilirubin < 1.5 mg/dl , Serum Creatinine < 1.5 mg/dl, BUN < 30,
  • The patients who understood the rights to withdraw the agreement at any time and signed on the informed consent form with or without their legal representatives.

Exclusion Criteria:

  • Remote metastatic disease
  • When the patient is concerned about the local recurrence if the preoperative chemo-radiation therapy is not undergone, or when the patient expects that the possibility of conservation of sphincter is improved owing to the preoperative chemo-radiotherapy.
  • Pregnancy
  • Radiotherapy, the past history of operation or chemotherapy
  • Familial multiple polyp
  • Uncontrolled psychiatric disorder, chronic alcohol disease or drug addiction and CNS(Central Nervous System) disorder
  • Other malignant disorder
  • After the radiotherapy or the case which remote metastasis is detected during the surgery
  • The case which has splanchnemphraxis or the risk of progression to occlusion during the examination period
  • Those patients who do not agree to participate in this study
  • The patients who seemed to be likely to stop in the middle of clinical study.
  • The patients who cannot undergo the regular follow-up owing to the following reasons. For instance, the patients who have psychologic, social, family or geographic reason or the patients who have difficulties in observing proper follow-up or clinical examination plan. Also, the patient who the doctor considers them as improper subjects of this study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00819559
Other Study ID Numbers  ICMJE KRCSG1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gyu-Seog Choi, Professor, School of Medicine, Kyungpook National University
Study Sponsor  ICMJE Korean Rectal Cancer Study Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gyu-Seog Choi, M.D. School of Medicine, Kyungpook National University
PRS Account Korean Rectal Cancer Study Group
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP