Randomized controlled study on preoperative chemoradiation assisted radical operation for mid-low rectal carcinoma

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-08000122

Enrollment

Unknown

Registered

2008-08-23

Start date

2008-03-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal carcinoma

Interventions

Group A:1. Routine preoperative radiotherapy (2 Gy once a day, 5 times/ week, for total 46 Gy) + concurrent chemotherapy (mXelox) + total mesorectum excision

2. Postoperative chemotherapy: Xelox.

Group B:Total mesorectum excision

postoperative chemotherapy: Xelox

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Features of diseases:Diagnosis of rectal adenocarcinoma by histology examination; Proximal edge of carcinoma within 10 cm of anal verge confirmed by enteroscopy;Preoperative stage: T3, T4 or N 1-2;No signs of intestinal obstruction or obstruction has been relieved by colostomy;Without metastasis confirmed by CT and X ray tests; 2. History or concurrent therapy:No rectal operation before;No chemotherapy before;No radiotherapy before;No restrict on biotherapy;No restrict on endocrine therapy; 3. Features of patients:Aged between 18 and 70 years old;ECOG 0-1;Expected life > 2 years;Hematology test: WBC>4000/mm3; PLT>100000/mm3; Hb>10g/dL;Hepatic function: SGOT and SGTP < 1.5*normal value; bilirubin < 1.5mg/dL; Renal function: creatinine < 1.8mg/dL; Others: non-pregnant or breast-feeding women; no other malignant diseases within 5 years (except melanoma or carcinoma in situs of cervix); no diseases causing disability of informed contents; no diseases that may shorten life period.

Exclusion criteria

Exclusion criteria: Dyscrasia, or organs dysfunction; Without signing informed contents forms; Multiple primary carcinomas; Other conditions that are not suitable to perform chemoradiation.

Design outcomes

Secondary

Measure	Time frame
Distant metastasis rate;Local recurrence rate;Pathological response rate;Clinical response rate;Rate of reserving the anus;	—

Primary

Measure	Time frame
Disease free survival rat;Sexual function;Bladder function;Acute side effects;Pathological complete response rate;	—

Countries

China

Contacts

Public ContactDesen Wan

wds@medmail.com.cn+86 020 87343124

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 4, 2026