A prospective randomized controlled clinical study of postoperative adjuvant radiotherapy for stage II and stage III upper rectal cancer above the peritoneal reflection (ARURC)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000035634

Enrollment

Unknown

Registered

2020-08-15

Start date

2020-10-01

Completion date

Unknown

Last updated

2020-08-31

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

Conditions

Rectal cancer

Interventions

Experimental group:Postoperative adjuvant radiotherapy

Control Group:No postoperative adjuvant radiotherapy

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18-75 years; (2) Pathologically confirmed rectal adenocarcinoma; (3) Preoperative colonoscopy confirmed that the inferior margin of the tumor is less than 15 cm from the anal verge; (4) The inferior margin of the tumor is above the anterior peritoneal reflection (comprehensively judged by preoperative MRI, intraoperative examination and postoperative pathological examination); (5) Stage II or stage III (pT3-4aN0 or pT1-4aN+) by postoperative pathological examination (6) No distant metastasis; (7) No preoperative radiotherapy or chemotherapy; (8) The primary tumor of rectal cancer had been resected radically (proximal margin, distal margin and circumferential margin are all negative); (9) ASA score is lower than 3; (10) The patient can understand the research plan and is willing to participate in the research, and provide written informed consent.

Exclusion criteria

Exclusion criteria: (1) History of other malignant tumor; (2) History of previous pelvic radiotherapy; (3) Synchronous or metachronous multiple primary colorectal cancers; (4) Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgical resection; (5) History of colorectal surgery which may affect this digestive tract reconstruction; (6) MDT discusses determine that the patient is not suitable for entering the study; (7) Pregnant or lactating women; (8) History of severe mental illness; (9) Continuous systemic steroid therapy within 1 month; (10) The patient has contraindications to take radiotherapy or chemotherapy.

Design outcomes

Primary

Measure	Time frame
3 year Local recurrence free survival;	—

Secondary

Measure	Time frame
3 year overall survival;3 year disease free survival;Life of quality;urination function;fecal continence;sexual function;Incidence of adverse events;	—

Countries

China

Contacts

Public ContactXian-Hua Gao

Shanghai Changhai Hospital

gxh505@126.com+86 021-31161613

Outcome results

None listed

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