Rectal NeoplasmNCT00819559
Preoperative Chemoradiotheray for Rectal Cancer
A study testing PCRT in people with Rectal Neoplasm, run by Korean Rectal Cancer Study Group at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rectal Neoplasm
- What is being tested?
- PCRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,160 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2009to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Korean Rectal Cancer Study Group
Daegu, 700-721
InJa Park, M.D., 82-2-519-8975, ijpark7@gmail.com
InJa Park, M.D.
About this study
Official title: 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.
Read the 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.
- Conditions
- Rectal Neoplasm
- Being tested
- PCRT
- Keywords
- Rectal neoplasm, Clinical stage, T3N0, Preoperative chemoradiotherapy, Laparoscopic, Open resection
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCRTRadiation
Also called preoperative chemoradiotherapy
Preoperative chemoradiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Open PCRT group | Active comparator | Patients who underwent preoperative chemoradiotherapy and open resection Receives: Radiation: PCRT |
| Open no PCRT group | Experimental | Patients who did not undergo preoperative chemoradiotherapy and open resection Receives: Radiation: PCRT |
| LAP PCRT group | Active comparator | Patients who underwent preoperative chemoradiotherapy and laparoscopic resection Receives: Radiation: PCRT |
| LAP no PCRT group | Experimental | Patients who did not undergo preoperative chemoradiotherapy and laparoscopic resection Receives: Radiation: PCRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Measured: 5 year
Secondary outcomes (1)
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
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startMar 2009
- Primary completionFeb 2011 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korean Rectal Cancer Study Group
- Sponsor type
- Research network
- Investigators
- Gyu-Seog Choi, M.D., Principal investigator, School of Medicine, Kyungpook National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819559
- Sponsor's protocol ID
- KRCSG1
- Status last verified
- Jan 2009
- First submitted
- 7 Jan 2009
- Last updated
- 12 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Preoperative Chemoradiotherapy in Clinically T3No Mid and Low Rectal Cancer : Multi-Institute Clinical Study
- ClinicalTrials.gov ID
- NCT00819559
- Acronym / sponsor ID
- KRCSG1
- Conditions
- Rectal Neoplasm
- Keywords
- Rectal neoplasm, Clinical stage, T3N0, Preoperative chemoradiotherapy, Laparoscopic, Open resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,160 participants (estimated)
- Lead sponsor
- Korean Rectal Cancer Study GroupResearch network
- Study start
- Mar 2009
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 9 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Open PCRT group | Active comparator | Radiation: PCRTPatients who underwent preoperative chemoradiotherapy and open resection |
| Open no PCRT group | Experimental | Radiation: PCRTPatients who did not undergo preoperative chemoradiotherapy and open resection |
| LAP PCRT group | Active comparator | Radiation: PCRTPatients who underwent preoperative chemoradiotherapy and laparoscopic resection |
| LAP no PCRT group | Experimental | Radiation: PCRTPatients who did not undergo preoperative chemoradiotherapy and laparoscopic resection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCRTAlso: preoperative chemoradiotherapyPreoperative chemoradiotherapy | Radiation | LAP PCRT group, LAP no PCRT group, Open PCRT group, Open no PCRT group |
Primary outcome
Disease-free survival
Time frame: 5 year
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gyu-Seog Choi, M.D. principal investigator
School of Medicine, Kyungpook National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCRT in people with Rectal Neoplasm, run by Korean Rectal Cancer Study Group at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact InJa Park, M.D. (82-2-519-8975, ijpark7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2009.