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

Phase 3

Active, not recruiting

• Conditions: Advanced Rectal Cancer
• Interventions: Drug: Induction chemotherapy, Chemoradiotherapy and gap chemotherapy (Capecitabine combine with oxaliplatin); Radiation: standard chemoradiotherapy

• Registration Number: NCT02031939
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-30
• Study Start: 2014-01
• Study First Submitted QC: 2014-01-08
• Study First Posted: 2014-01-09
• Primary Completion: 2020-12
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-23
• Last Update Posted: 2023-08-25
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 556

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
induction and gap chemotherapy	Induction chemotherapy, Chemoradiotherapy and gap chemotherapy (Capecitabine combine with oxaliplatin)	induction chemotherapy (Capecitabine 2000mg/m2 +oxaliplatine 130mg/m2) + 2 cycles of chemoradiotherapy (Capecitabine 2000mg/m2 +oxaliplatine 100mg/m2 combined with radiotherapy) + gap chemotherapy (Capecitabine 2000mg/m2 + oxaliplatine 130mg/m2)
Standard chemoradiotherapy	standard chemoradiotherapy	Standard chemoradiotherapy (Capecitabine 825mg/m2 combined with radiotherapy )

Primary Outcome Measures

Name	Time	Method
overall survival	5 years

Secondary Outcome Measures

Name	Time	Method
Respond rate	One week after surgery
Disease free survival	5 years
disease free survival	3 years

Trial Locations

Locations (1)

Sun Yat-Sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China