rectal cancer
Conditions
Interventions
preoperative radiotherapy group:preoperative radiotherapy and operation
intraoperative radiotherapy group:intraoperative radiotherapy,operation and postoperative chemotherapy
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) infiltrative rectal adenocarcinoma; (2) more than 18 years-old; (3) WHO performance status inferior or equal to 2; (4) distance between anal margin and tumor less than 12 cm; (5) T3 with MRF or EMVI positive or T4 or N+ and M0 according to radiology; (6) patients treated with a preoperative radiotherapy with good general and visceral conditions allowing surgery and possible prolonged operative time.
Exclusion criteria
Exclusion criteria: (1) the pathological diagnosis is not adenocarcinoma or multiform pathological types; (2) with clinical symptoms requiring emergency surgery for treatment (complete obstruction, bleeding, intestinal perforation); (3) have received chemotherapy treatment or combined with other the anti-tumor treatment; (4) with serious basic diseases: heart disease, kidney failure, severe liver dysfunction or liver failure, coagulation dysfunction or oral dose of anticoagulant drugs; (5) any other contraindications for the use of radiotherapy; (6) patients with pregnancy; (7) with other detectable metastasis; (8) multiple primary colon cancer patients, or suffer from other malignant tumors, or have been systematic chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;postoperative complications;operative duration; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection;positive lymph nodes;TRG;The proportion of patients receiving adjuvant chemotherapy after surgery;rate of anus preservation;????????;rate of recurrence;DFS;3 years survival rate; | — |
Countries
China
Contacts
Public ContactXishan Wang,Zheng Jiang
Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed