Rectal Neoplasms
Conditions
Keywords
Rectal Neoplasms, Adjuvant Chemotherapy, Neoadjuvant Chemoradiotherapy
Brief summary
The purpose of this study is to evaluate the efficacy of adjuvant chemotherapy in patients with clinical stage III rectal cancer who received neoadjuvant chemoradiotherapy on the basis of postoperative pathological stage.
Detailed description
Previous studies have proved that neoadjuvant radiotherapy can decrease the rate of local recurrence rather than distal metastases in advanced rectal cancer. Moreover, the local control was not responsible for survival benefit. Adjuvant chemotherapy is capable of eliminating the micrometastasis, rendering better prognosis to rectal cancer. However, the application of adjuvant chemotherapy depends largely on the evidence from colon cancer. At present, controversy remains on the clinical value of adjuvant chemotherapy in patients with rectal cancer who received neoadjuvant chemoradiotherapy. Besides that, the pathological stage followed by neoadjuvant chemoradiotherapy may have an effect on the evaluation of adjuvant chemotherapy. According to the postoperative pathological stage, the present study was designed as a non-inferiority trail for patients with pathological complete response or yp stage I to compare the long-term outcomes of observational group and those receiving 5-fluorouracil. For patients with yp stage II or III, the study aims to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone.
Interventions
DRUGCapecitabine
According to the postoperative pathological stage, the present study was designed as a non-inferiority trail for patients with pathological complete response or yp stage I to compare the long-term outcomes of observational group and those receiving 5-fluorouracil. For patients with yp stage II or III, the study aims to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone.
DRUGmFOLFOX6 or CAPOX
According to the postoperative pathological stage, the present study was designed as a non-inferiority trail for patients with pathological complete response or yp stage I to compare the long-term outcomes of observational group and those receiving 5-fluorouracil. For patients with yp stage II or III, the study aims to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone.
Sponsors
LI XIN-XIANG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* The lesion must be within 12 cm of the anus as measured by endoscopy * Histologically confirmed diagnosis of rectal carcinoma * CT, MRI and EUS verified as clinical stage III rectal cancer without involvement of other organs * Without multiple primary cancer * Sufficient organ function * Able to provide written informed consent
Exclusion criteria
* Younger than 18 years or older than 75 years * Synchronous or metachronous malignancy within 5 years. * Patients with Intestinal obstruction or perforation or bleeding who require emergency surgery. * Patients with a history of pelvic irradiation. * ASA grade IV or V. * Women who are pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding. * Severe mental illness. * Patients with severe emphysema, interstitial pneumonia, or ischemic heart disease who can not tolerate surgery. * Patients who received steroid therapy within one month. * Patients or family members misunderstand the conditions and goals of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival | 3-year | Calculated from the date of surgery to the date of recurrence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 3-year, 5-year | Calculated from the date of diagnosis to the date of death from any cause |
| Disease free survival | 5-year | Calculated from the date of surgery to the date of recurrence |
| The rate of local recurrence | 3-year | The ratio of the number of local recurrence to the total patients |
| The rate of adverse events resulted from chemotherapy | 3-year | The ratio of the number of patients experienced adverse events to the total patients |
| The quality of life postoperatively | 3-month, 6-month, 9-month, 12-month, 18-month, 24-month | The European Organization for Research and Treatment (EORTC)-QLQ-C30 HRQL questionnaire was assessed with repeated measures at regular intervals postoperatively at months 3, 6, 9, 12, 18, and 24 |
Countries
China
Contacts
Primary ContactXinxiang Li, MD,PhD
Backup ContactQingguo Li, MD,PhD
Outcome results
None listed