Randomized Clinical Trial on Preoperative Radiotherapy 25 Gy in Rectal Cancer

Jagiellonian University

Status: Completed

Conditions: Rectal Cancer

Treatments: Procedure: Surgery; Radiation: Preoperative radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01444495

Cracow Rectal Cancer Trial

Details and patient eligibility

About

The purpose of this study is to establish the influence of time-interval between preoperative hyperfractionated radiotherapy (5x5 Gy) and surgery on long term overall survival (5 years), local and distant recurrence rate, downstaging rate, sphincter saving procedures, radical resection rate (R0) in patients with locally advanced rectal cancer operated on according to TME technique. In particular 3D endosonography and 3rd generation ultrasonic contrast agents are evaluated to assess response to radiotherapy.

Full description

The treatment group comprises patients with locally advanced rectal cancer who were operated on in the 1st Department of General Surgery, Jagiellonian University, Cracow. The data on survival has been systematically collected using national census registry. Patients are qualified to preoperative radiotherapy 5x5 Gy and then randomly assigned to subgroups with different time interval between radiotherapy and surgery: one subgroup consists of patients operated on 7-10 days after the end of irradiation, the second subgroup consists of patients operated on after 4-5 weeks. Both should be homogenous in sex, age, cancer stage and localization, distal and circumferential resection margins, number of resected lymph nodes. 3D endorectal ultrasound and endorectal ultrasound with SonoVue are performed to assess the tumor before and after preoperative radiotherapy.

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically confirmed rectal cancer
• tumor localised in middle or lower rectum
• age > 18 years
• locally advanced cancer

Exclusion criteria

• previous pelvis radiotherapy
• lack of patient's consent
• lack of possibility to begin radiotherapy during 14 days after inclusion to the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 2 patient groups

Short time interval

Active Comparator group

Description:

Patients operated on 7-10 days after completing preoperative radiotherapy 5x5Gy.

Treatment:

Radiation: Preoperative radiotherapy

Procedure: Surgery

Long time interval

Experimental group

Description:

Patients operated on 4-5 weeks after completing preoperative radiotherapy 5x5Gy.

Treatment:

Radiation: Preoperative radiotherapy

Procedure: Surgery