Preoperative short-course radiation therapy in rectal cancer

Phase 2

Recruiting

• Conditions: Malignant neoplasm of rectum; Rectal cancer.

• Registration Number: IRCT20190119042415N1
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Patients with newly diagnosed rectal cancer with up to 16 cm distance from anal verge
Histologically confirmed adenocarcinoma
Initial pathological stage of T3 or T4 and/or N+
No history of initial distant metastases
ECOG-performance status < 2 6. Age = 18 years
Adequate bone marrow, hepatic and renal functions
Signing the informed consent

Exclusion Criteria

Pregnancy
Previous pelvic radiotherapy
Hypersensitivity to fluorouracil, oxaliplatin or capecitabine
Serious medical illness
Distance metastasis

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathologic complete response. Timepoint: Post operation. Method of measurement: Pathologic examination.

Secondary Outcome Measures

Name	Time	Method
Side effects. Timepoint: Weekly during intervention course. Method of measurement: Radiation therapy oncology group toxicity criteria.