Validate the Dosimetric Parameters That Correlate With Acute Hematologic Toxicity (HT) in Patients With Rectal Cancer

Rectal Neoplasm Clinical Trial

Official title:

Validate the Dosimetric Parameters That Correlate With Acute Hematologic Toxicity (HT) in Patients With Rectal Cancer Treated With Neoadjuvant Chemoradiotherapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02630056
• Other study ID #: SASYSU
• Status: Not yet recruiting
• Phase: N/A
• First received: November 27, 2015
• Last updated: December 14, 2015
• Start date: December 2015
• Est. completion date: December 2017

Study information

• Verified date: November 2015
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to validate the dosimetric parameters that correlate with acute hematologic toxicity (HT) in patients with rectal cancer treated with neoadjuvant chemoradiotherapy.

Description:

The investigators' ongoing retrospective study investigated the clinical and dosimetric parameter (dosimetry of pelvic bone marrow) which relate with acute hematologic toxicity in patient with rectal cancer treated with neoadjuvant chemoradiotherapy. In order to validate the dosimetric limitation of pelvic bone marrow in decreasing the intensity of HT, the investigators want to conduct a study to observe the acute HT without assigning any specific interventions to the subjects of the study, who will receive the standard treatment according to the multidisciplinary team's (MDT) decision and patient choice. Therefore, this study's type is observational.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• rectal cancer

• receive neoadjuvant chemoradiotherapy

Exclusion Criteria:

• hematological system disorders

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Rectal Neoplasm
• Rectal Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the grade of acute hematologic toxicity	Hematologic Adverse Events That Are Related to Pelvic Bone Marrow Irradiation	5-6 weeks	No