Prospectively Randomized Control Clinical Trial of FOLFOXIRI Preoperative Chemotherapy Alone on Rectal Cancer in Local Advance Comparing to Oral Capecitabine Combined With Long-term Radiation

Recruiting Phase 3 Interventional Study
Rectal Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
776 (estimated)
Sponsor
Sun Yat-sen University · Other
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About This Trial
Preoperative radiation and chemotherapy is the standard treatment for local advanced rectal cancer. The addition of oxaliplatin to capecitabine combined with radiotherapy does not improve local control and long-term survival. Most importantly,chemoradiotherapy significantly increased surgical complication and poor long-term quality of life .In the absence of effective measures of predicting chemo-…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 1)Age: 18 to 75 years old; * 2)Histological diagnosis of rectal adenocarcinoma; * 3)Distance form anal margin ≤ 5cm: cT3-4aN + M0, there is no distant metastasis, lymph node positive, or the tumor breaking through the muscular layer, no invasion of the adjacent organs , positi…
Contacts

ZhiZhong Pan

8613719388166

panzhzh@sysucc.org.cn

CONTACT

Rui-hua Xu

8613922206676

ruihxu@163.com

CONTACT