NCT02031939

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 556 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Rectal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-01-01
• Primary completion: 2020-12-01
• Completion: 2025-12-01
• First posted: 2014-01-09
• Last updated: 2023-08-25

Locations

1 site across 1 country: China