Randomized Controlled Study on Optimize Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer

Advanced Rectal Cancer Clinical Trial

Official title:

Randomized Controlled Study on Optimize Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02031939
• Other study ID #: 2013013
• Secondary ID: SYSU5010Fund
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 2014
• Est. completion date: December 2025

Study information

• Verified date: August 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Although neoadjuvant chemoradiotherapy has significantly reduced the risk of local recurrence in locally advanced rectal cancer, systemic failure remains a predominant issue probably due to the insufficient control of systemic micro-metastasis in the neoadjuvant treatment. Induction chemotherapy is one of the most studied strategies. However, the efficacy of induction chemotherapy prior to neoadjuvant chemotherapy remains controversial. In our previous study, induction chemotherapy, gap chemotherapy combined with neoadjuvant chemoradiotherapy can improve response rate of rectal cancer patients, but the results have not been confirmed in clinical trial. Whether this new kind of treatment can optimize neoadjuvant therapy for locally advanced rectal cancer or not is still a big problem in clinical practice. This study will focus on how to optimize neoadjuvant chemotherapy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 556
• Est. completion date: December 2025
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Pathological confirmed rectal cancer

• Clinical stage T3-4 or T any N1

• No metastasis

• Distance of tumor is no more than 10cm from anal verge

• No previous radiotherapy

• Age ranged from 18 to 70

• Eastern Cooperative Oncology Group score system 0-1

Exclusion Criteria:

• Clinical stage T1-2 N0

• Distance metastasis

• Multiple primary tumor

• Cachexy

Related Conditions & MeSH terms

• Advanced Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• Induction chemotherapy, Chemoradiotherapy and gap chemotherapy (Capecitabine combine with oxaliplatin)
All rectal cancer patients in this group will receive induction, gap chemotherapy (capecitabine combined with oxaliplatin) alone with chemoradiotherapy (capecitabine combine with oxaliplatin) before surgery.

Radiation:
• standard chemoradiotherapy
All rectal patients in this group will receive standard radiotherapy and surgical resection.

Locations

Country	Name	City	State
China	Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		5 years
Secondary	disease free survival		3 years
Secondary	Disease free survival		5 years
Secondary	Respond rate		One week after surgery