Status:
UNKNOWN
Preoperative Chemoradiotheray for Rectal Cancer
Lead Sponsor:
Korean Rectal Cancer Study Group
Conditions:
Rectal Neoplasm
Eligibility:
All Genders
18-70 years
Phase:
NA
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 pr...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
1160 Patients enrolled
Trial Details
Trial ID
NCT00819559
Start Date
March 1 2009
End Date
December 1 2016
Last Update
January 12 2009
Active Locations (1)
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1
Korean Rectal Cancer Study Group
Daegu, South Korea, 700-721