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

Sun Yat-sen University

Status and phase: Active, not recruiting; Phase 3

Conditions: Advanced Rectal Cancer

Treatments: Drug: Induction chemotherapy, Chemoradiotherapy and gap chemotherapy (Capecitabine combine with oxaliplatin); Radiation: standard chemoradiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02031939

SYSU5010Fund (Other Grant/Funding Number)

2013013

Details and patient eligibility

About

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.

Enrollment: 556 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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556 participants in 2 patient groups

Standard chemoradiotherapy

Active Comparator group

Description:

Standard chemoradiotherapy (Capecitabine 825mg/m2 combined with radiotherapy )

Treatment:

Radiation: standard chemoradiotherapy

induction and gap chemotherapy

Experimental group

Description:

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)

Treatment:

Drug: Induction chemotherapy, Chemoradiotherapy and gap chemotherapy (Capecitabine combine with oxaliplatin)