- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00819559
Preoperative Chemoradiotheray for Rectal Cancer
January 8, 2009 updated by: Korean Rectal Cancer Study Group
Role of Preoperative Chemoradiotherapy in Clinically T3No Mid and Low Rectal Cancer : Multi-Institute Clinical Study
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.
Study Overview
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
Interventional
Enrollment (Anticipated)
1160
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: InJa Park, M.D.
- Phone Number: 82-2-519-8975
- Email: ijpark7@gmail.com
Study Locations
-
-
-
Daegu, Korea, Republic of, 700-721
- Korean Rectal Cancer Study Group
-
Contact:
- InJa Park, M.D.
- Phone Number: 82-2-519-8975
- Email: ijpark7@gmail.com
-
Sub-Investigator:
- InJa Park, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Open PCRT group
Patients who underwent preoperative chemoradiotherapy and open resection
|
Preoperative chemoradiotherapy
Other Names:
|
Experimental: Open no PCRT group
Patients who did not undergo preoperative chemoradiotherapy and open resection
|
Preoperative chemoradiotherapy
Other Names:
|
Active Comparator: LAP PCRT group
Patients who underwent preoperative chemoradiotherapy and laparoscopic resection
|
Preoperative chemoradiotherapy
Other Names:
|
Experimental: LAP no PCRT group
Patients who did not undergo preoperative chemoradiotherapy and laparoscopic resection
|
Preoperative chemoradiotherapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease-free survival
Time Frame: 5 year
|
5 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gyu-Seog Choi, M.D., School of Medicine, Kyungpook National University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Anticipated)
February 1, 2011
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
January 7, 2009
First Submitted That Met QC Criteria
January 7, 2009
First Posted (Estimate)
January 9, 2009
Study Record Updates
Last Update Posted (Estimate)
January 12, 2009
Last Update Submitted That Met QC Criteria
January 8, 2009
Last Verified
January 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KRCSG1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rectal Neoplasm
-
Hôpital Edouard HerriotCompletedStomach Neoplasm | Rectal Neoplasm | Intestinal NeoplasmFrance
-
Osama Rahma, MDMerck Sharp & Dohme LLC; Hoosier Cancer Research NetworkWithdrawnRectal Cancer | Rectal Neoplasm
-
Fudan UniversityCompletedRectal Neoplasm With Metastasis to the Liver
-
Karolinska University HospitalRecruiting
-
National Cancer Center, KoreaUnknown
-
University of DundeeTerminatedRectal NeoplasmUnited Kingdom
-
Aalborg University HospitalActive, not recruitingRectal Cancer | Rectal Adenocarcinoma | Locally Advanced Malignant NeoplasmDenmark
-
Joseph Caster, Ph.D., M.D.GlaxoSmithKlineRecruitingRectal Neoplasms | Rectal Neoplasm MalignantUnited States
-
Instituto Nacional de Cancer, BrazilCompleted
-
Fundación de Investigación Biomédica - Hospital...Hospital Universitario La Fe; Hospital Alemão Oswaldo Cruz; Complejo Hospitalario...Not yet recruitingRectal Cancer | Rectum Neoplasm