Efficacy of Adjuvant Chemotherapy in Patients With Clinical Stage III Rectal Cancer Undergoing Neoadjuvant Chemoradiotherapy: A Pathology-oriented, Prospective, Multicenter, Randomized, Open-label, Parallel Group Clinical Trial
| Registry | NCT03415763 |
|---|---|
| Status | Unknown |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 764 (Estimated) |
| Sponsor | LI XIN-XIANG (Other) |
| Conditions | Rectal Neoplasms |
| Interventions | Capecitabine, mFOLFOX6 or CAPOX (Drug) |
| Dates | start 2018-11-05, primary completion 2020-12-01 (estimated), completion 2025-12-01 (estimated), first posted 2018-01-30, last updated 2018-11-06 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Rectal Neoplasms All trials of Capecitabine All trials of mFOLFOX6 or CAPOX
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Observation | No intervention | Observation for patients with pathological complete response or yp stage I(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) | |
| 5-fluorouracil | Experimental | Drug: Capecitabine | Capecitabine for patients with pathological complete response or yp stage I Capecitabine 1250 mg/m2 twice daily for 14 days in a 3-week cycle to be administered orally after food, three cycles(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 ) |
| 5-fluorouracil alone | Experimental | Drug: Capecitabine | 5-fluorouracil alone for patients with yp stage II or III Capecitabine 1250 mg/m2 twice daily for 14 days in a 3-week cycle to be administered orally after food, three cycles(According to the postoperative pathological stage, the present study was designed as a superiority trail for patients with yp stage II or III to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone) |
| mFOLFOX6 or CAPOX | Experimental | Drug: mFOLFOX6 or CAPOX | Oxaliplatin combined with 5-fluorouracil for patients with yp stage II or III mFOLFOX6 (leucovorin 400 mg/m2 as a 2-hour infusion, and the concurrent administration of oxaliplatin 85 mg/m2 as a 2-hour infusion, followed by a bolus of 5-FU 400 mg/m2 within 15 min and 46-hour infusion of 5-FU 2400 mg/m2 on day 1 every 2 weeks), three cycles or CAPOX (oxaliplatin 130 mg/m2 as a 2-hour infusion on day 1, followed by capecitabine 1000 mg/m2 twice daily for 14 days every 3 weeks), three cycles( According to the postoperative pathological stage, the present study was designed as a superiority trail for patients with yp stage II or III to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone) |
Sex: All, ages: 18 Years to 75 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai, Shanghai Municipality | China | Recruiting |