Preoperative Chemoradiotheray for Rectal Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2009 by Korean Rectal Cancer Study Group
Sponsor:
Information provided by:
Korean Rectal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00819559
First received: January 7, 2009
Last updated: January 8, 2009
Last verified: January 2009
  Purpose

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.

Condition Intervention
Rectal Neoplasm
Radiation: PCRT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Role of Preoperative Chemoradiotherapy in Clinically T3No Mid and Low Rectal Cancer : Multi-Institute Clinical Study

Resource links provided by NLM:


Further study details as provided by Korean Rectal Cancer Study Group:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1160
Study Start Date: March 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Open PCRT group
Patients who underwent preoperative chemoradiotherapy and open resection
Radiation: PCRT
Preoperative chemoradiotherapy
Other Name: preoperative chemoradiotherapy
Experimental: Open no PCRT group
Patients who did not undergo preoperative chemoradiotherapy and open resection
Radiation: PCRT
Preoperative chemoradiotherapy
Other Name: preoperative chemoradiotherapy
Active Comparator: LAP PCRT group
Patients who underwent preoperative chemoradiotherapy and laparoscopic resection
Radiation: PCRT
Preoperative chemoradiotherapy
Other Name: preoperative chemoradiotherapy
Experimental: LAP no PCRT group
Patients who did not undergo preoperative chemoradiotherapy and laparoscopic resection
Radiation: PCRT
Preoperative chemoradiotherapy
Other Name: preoperative chemoradiotherapy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819559

Contacts
Contact: InJa Park, M.D. 82-2-519-8975 ijpark7@gmail.com

Locations
Korea, Republic of
Korean Rectal Cancer Study Group Not yet recruiting
Daegu, Korea, Republic of, 700-721
Contact: InJa Park, M.D.    82-2-519-8975    ijpark7@gmail.com   
Sub-Investigator: InJa Park, M.D.         
Sponsors and Collaborators
Korean Rectal Cancer Study Group
Investigators
Principal Investigator: Gyu-Seog Choi, M.D. School of Medicine, Kyungpook National University
  More Information

No publications provided

Responsible Party: Gyu-Seog Choi, Professor, School of Medicine, Kyungpook National University
ClinicalTrials.gov Identifier: NCT00819559     History of Changes
Other Study ID Numbers: KRCSG1
Study First Received: January 7, 2009
Last Updated: January 8, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korean Rectal Cancer Study Group:
Rectal neoplasm
Clinical stage
T3N0
Preoperative chemoradiotherapy
Laparoscopic
Open resection

Additional relevant MeSH terms:
Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on October 16, 2014