|Phase IV||Treatment||Active||18 to 80||Other||pSRT-201106|
The local recurrence after the radical operation of rectal cancer is the main problem that confusing the doctor and the patients. The preoperative adjuvant chemo-radiotherapy has been confirmed to be effective to reduce the local recurrence rate,especially the advanced resectable rectal cancer. As the invading state of the mesorectum by the tumor and the integrity of the mesorectum after the operation are the most critical factor for the local recurrence. So that, how to select the patients with high risk of local recurrence to have a radiotherapy before the operation, which both reducing the local recurrence rate and decreasing the adverse effect of the radiotherapy, over treatment,and avoiding the waste of the medical resource, became a problem. This trial was mainly focus on the patients whose preoperative stage was T3 or N+. These patients which included will be divided in to 2 subgroup, the early mesorectal involvement group (EMRI) and the late mesorectal involvement group (LMRI) according the preoperative CT and Endoscopic ultrasound,and carrying out randomized trial in the two groups individually.The purpose of this trial is to confirm whether the preoperative radiotherapy is necessary for the EMRI patients,identify the reason of the local recurrence,and finally help the making of the treatment decision for the advanced resectable rectal cancer.
Further Study Information
The colorectal cancer is the secondary most common cancer among the population. Every year,it's estimated that there was over 1,200,000 new cases,and in China the data is about 440,000. The local recurrence (LR) and the lung or liver metastasis are the most critical problems that confusing the doctor,which the local recurrence rate is about 3%-50%,with a median rate of 18.8%。 Now, multidisciplinary treatment become a standard treatment for the rectal cancer, and the preoperative adjuvant chemoradiotherapy is a critical part of the therapy. As various trials have confirmed that the preoperative chemoradiotherapy can reduce the postoperative local recurrence rate. And,there are two kinds of preoperative adjuvant therapy,the long-term chemoradiotherapy and the short-term radiotherapy. In the US, the long-term is more common,with a total dose of 50.4 Gy in 25-28 fraction,and in the Europe, the short-term are more common with a dose of 25 Gy in 5 fraction.For the two,there is no conclusion about which is better. The National Comprehensive Cancer Network(NCCN) guideline recommend that for the patients with preoperative stage T3N0，or T1-3N1-2,preoperative radiotherapy is necessary.However the Polish Colorectal Study Group found that there is no difference in survival, local recurrence or late toxicity,in the short-term radiotherapy,with a less Early radiation toxicity.So that the short is more regarded.
Although the preoperative radiotherapy can decrease the local recurrence, it can't increase the 5-year survival. The reason for the radiotherapy reducing the local recurrence was that the radiation decreased the positive rate of the circumferential resection margin(CRM) of the total mesorectal excision(TME) operation. In a recent prospective trial in UK, the preoperative adjuvant radiotherapy can decrease the local recurrence with different operation quality(both completed TME or uncompleted TME), however a defect of this trial was that the lymph node positive patients were not receiving the postoperative supplementary radiation.
One of the other factors influencing the LR is the operation quality, completely resection of the mesorectum can decrease the LR to about 4%. As the obesity can influence the TME, in the Asia the experienced surgeon can have a higher rate of mesorectum resection,in the thinner asian.
Overall, for the patients that the tumor have not invaded the mesorectum and the operation has a completely resection of the mesorectum, the preoperative adjuvant radiotherapy may have no difference with the selective postoperative chemoradiotherapy. In addition to this,the preoperative adjuvant therapy can induce various complications,injury of the nervous plexus, radical rectitis,increasing the infection rate of the wound. About 5%-10% radioresistant patients has the carcinoma enlarged or metastasis during the adjuvant treatment.
So that,dividing the T3 patients into subgroups, that for the CRM may positive or the lymph node may positive,the preoperative radiotherapy may be positive, and for the preoperative negative CRM and no lymph node metastasis,the radiotherapy may have a negative effect. This trial was mainly focus on the patients whose preoperative stage was T3 or N+. The patients which included will be divided in to 2 subgroup according the preoperative CT and Endoscopic ultrasound,the early mesorectal involvement group (EMRI): the tumor invade into the mesorectum<=5mm,or the hole bowel in the peritoneum covering part; in the anterior wall ,the tumor had not invaded into the fat tissue; there is no high-density image in the mesorectum in the CT scan; there is no enlarged lymph node that larger than 8mm; if the preoperative stage is T1-3N+,the lymph node <=8mm; and the late mesorectal involvement group (LMRI): the tumor invade into the mesorectum >5mm, in the lateral or posterior part. There is high-density image in the mesorectum in the CT scan; there is enlarged lymph node which is larger than 8mm; the tumor invade the whole circle of the bowel by anal examination;and carry out randomized trial in the two groups individually. The purpose of this trial is to confirm whether the preoperative radiotherapy is necessary for the EMRI patients,identify the reason of the local recurrence,and finally help the making of the treatment decision for the advanced resectable rectal cancer.
1. histologically verified adenocarcinoma of the rectum;
2. the lower border of the tumor within 12cm of the anal verge;
3. age between 18 to 80 years;
4. preoperative endosonography and the abdominopelvic CT diagnosis as early mesorectal involvement or late mesorectal involvement(the detail of these two subgroup was illustrated in the detailed description of this trial);
5. ECOS ≤ 2
6. there was no evidence of metastasis with chest and abdominopelvic CT.
1. with other colorectal cancer, or other cancer,simultaneously;
2. Locally recurrent rectal cancer;
3. had a history of malignant tumor within 5 years(except the skin cancer);
4. Pregnant or lactating women
5. there was contraindication for the preoperative adjuvant radiotherapy or the operation.
6. with antitumor drug or radiation before this trial.
7. discovery of metastasis in the operation
8. worrying about the local recurrence or the adverse effect of the radiation excessively;
9. with mental disorder.
Trial Lead Organizations/Sponsors
West China Hospital at Sichuan University
|Deng Xiang bing||Ph: +8613730677124|
|Wang Kang, MD||Principal Investigator|
|Sichuan academy of medical science and sichuan provincial people's hospictal|
|Wang Kang, chief surgeon||Ph: 134455324242|
|Liu Yan jun, MD||Principal Investigator|
|the Third People'S Hospital of Chengdu|
|Liu Yan jun, MD||Ph: 15108402860|
|Xu feng||Principal Investigator|
|Shu ye||Principal Investigator|
|Deng xiang bing||Ph: +86-13730677124|
|West China Hospital at Sichuan University|
|Wang zi qiang||Ph: +86-18980602028|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01437514
Information obtained from ClinicalTrials.gov on February 24, 2013
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