Study: NCT02121405

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Rectectomy
Description: Include anterior resection or abdominoperineal resection by open or laparoscopy with Total Mesorectal Excision (TME).

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Rectectomy
Description: Include anterior resection or abdominoperineal resection by open or laparoscopy with Total Mesorectal Excision (TME).

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: Radiotherapy
Description: 45-50 Gy in 25-28 fractions to the pelvis. After 45 Gy a tumor bed boost with a 2 cm margin of 5.4 Gy in 3 fractions for preoperative cancers or 5.4-9.0 Gy in 3-5 fractions for postoperative cancers could be considered. Radiotherapy is used only for patients with pathological confirmed positive circumferential margin in Group primary surgery. Radiotherapy is used to all of the patients in Group preoperative radiochemotherapy.

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Radiotherapy
Description: 45-50 Gy in 25-28 fractions to the pelvis. After 45 Gy a tumor bed boost with a 2 cm margin of 5.4 Gy in 3 fractions for preoperative cancers or 5.4-9.0 Gy in 3-5 fractions for postoperative cancers could be considered. Radiotherapy is used only for patients with pathological confirmed positive circumferential margin in Group primary surgery. Radiotherapy is used to all of the patients in Group preoperative radiochemotherapy.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Capecitabine
Description: Capecitabine 825 mg/m2 twice daily 5 or 7 days/week with concurrent radiotherapy in Group primary surgery and Group preoperative radiochemotherapy. Capecitabine 1250 mg/m2 twice daily 1-14 every 3 weeks to a total of 6 weeks after preoperative radiochemotherapy in Group preoperative radiochemotherapy. Capecitabine 1250 mg/m2 twice daily 1-14 every 3 weeks to a total of 6 months postoperative therapy for a part of stage II patients in Group of primary surgery. Capecitabine 1000 mg/m2 twice daily 1-14 every 3 weeks with oxaliplatin day 1 to a total of 6 months postoperative therapy for stage III patients in Group of primary surgery.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Capecitabine
Description: Capecitabine 825 mg/m2 twice daily 5 or 7 days/week with concurrent radiotherapy in Group primary surgery and Group preoperative radiochemotherapy. Capecitabine 1250 mg/m2 twice daily 1-14 every 3 weeks to a total of 6 weeks after preoperative radiochemotherapy in Group preoperative radiochemotherapy. Capecitabine 1250 mg/m2 twice daily 1-14 every 3 weeks to a total of 6 months postoperative therapy for a part of stage II patients in Group of primary surgery. Capecitabine 1000 mg/m2 twice daily 1-14 every 3 weeks with oxaliplatin day 1 to a total of 6 months postoperative therapy for stage III patients in Group of primary surgery.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Oxaliplatin
Description: Oxaliplatin 130 mg/m2 over 2 hours, day 1, with capecitabine every 3 weeks. Repeat every 3 weeks to total of 6 months postoperative therapy.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oxaliplatin
Description: Oxaliplatin 130 mg/m2 over 2 hours, day 1, with capecitabine every 3 weeks. Repeat every 3 weeks to total of 6 months postoperative therapy.