Study of Intraoperative Radiotherapy for Middle and Low Rectal Cancer (IROT)

Jilin University

Status: Unknown

Conditions: Rectal Cancer

Treatments: Radiation: Intraoperative radiotherapy by Intrabeam（Zeiss Meditech，Jena，Germany）

Study type: Interventional

Funder types: Other

Identifiers

NCT03209336

SecondJilinU-IORT

Details and patient eligibility

About

To study the application of Intersphincteric Resection（ISR）combined with intraoperative radiation therapy(IORT) for ultra-low rectal cancer,and to broaden the surgical indications of Intersphincteric Resection（ISR.

The study is aimed to assess the postoperative acute complication and the short-term acute efficacy on the patients with middle and low rectal cancer by treated with intraoperative radiotherapy,especially those with peritoneal inversion rectal cancer.

Full description

Abstract objective: To study the application of Intersphincteric Resection（ISR）combined with intraoperative radiation therapy(IORT) for ultra-low rectal cancer,and to broaden the surgical indications of Intersphincteric Resection（ISR）.

Methods: Patients, who were diagnosed with ultra-low rectal cancer and had strong desire of preserving anal function, will take part in the research,whose tumor invading the levator ani muscle or above, the diameter less than 6cm, the lower tumor margin away from the anal verge by less than 5cm and away from the dentate line by less than 3cm.They will undergo total mesorectal excision(TME) and ISR combined with IORT and prophylactic ileostomy.

Outcomes Measures:The evaluation of short term effects includes complications such as anastomotic leakage, acute radiation injury ,urinary dysfunction ,dysfunction of anal sphincter ,sexual dysfunction ,local recurrence , total life expectancy and expectancy without metastasis. The postoperative pathological examination reported to be moderately differentiated adenocarcinoma .We wili assess their postoperative acute complications and short-term efficacy .Their time of follow up visit wil be 1 year or more.

Enrollment: 50 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Inclusion Criteria:

• Aged 40 to 80 years old, gender not limited.
• Be diagnosed as colorectal cancer by coloscopy.
• Patients with middle and low rectal cancer,whose preoperative staging evaluation is T3 ,T4 or N+.
• Accept surgery and intraoperative radiotherapy.
• Signed informed consent

Exclusion criteria

• the patients whose preoperative evaluation is below T3 stage with middle and rectal cancer.
• Active internal bleeding (such as gastrointestinal bleeding), urogenital system, or have not cure of peptic ulcer in four weeks
• Severe liver and kidney dysfunction
• Intracranial tumor, suspicious aortic dissection, arteriovenous malformation, aneurysm
• Thrombolysis treatment in one week
• Allergies of thrombolysis drug or contrast
• Participated in any clinical trials within three months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

A group

Experimental group

Description:

Colorectal cancer patients first are given antineoplastic drugs and then transfer to operative room to be treated by surgical resection and the radiotherapy is given during the operation after the removal of the tumour.

Treatment:

Radiation: Intraoperative radiotherapy by Intrabeam（Zeiss Meditech，Jena，Germany）

B group

No Intervention group

Description:

Colorectal cancer patients first are given antineoplastic drugs and then transfer to operative room to be treated only by surgical resection and no radiotherapy afer the removal of the tumour.