Rectal Cancer
Conditions
Keywords
Preoperative Chemoradiotherapy, Locally Advanced Rectal Cancer, boost, IMRT
Brief summary
Pathological complete response, (pCR) correlates with a favorable overall prognosis in locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a pCR might be beneficial. The aim of the study is to investigate safety and efficacy of preoperative SIB-IMRT(56Gy) combine with capecitabine. primary endpoint is pathological complete remission rate.
Interventions
RADIATIONconventional fraction
capecitabine 825mg/m2 p.o. twice daily Radiotherapy 50Gy/25f
RADIATIONSIB
Concomitant chemoradiotherapy Radiotherapy with boost Radiotherapy (25 x 2 Gy), with a simultaneous integrated boost up to 56 Gy on the primary tumor capecitabine 825mg/m2 p.o. twice daily
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* histopathologically confirmed rectal adenocarcinoma with an inferior border within 15 cm of the anal verge * the tumor has to have evidence of T3 or T4 disease on Magnetic Resonance Imaging (MRI) or endoluminal ultrasound
Exclusion criteria
* metastatic disease * Eastern Cooperative Oncology Group (ECOG) performance status \> 3 * patients not deemed fit for radiotherapy, capecitabine or surgery * pregnant or lactating patients * women with child bearing potential who lack effective contraception * patients below 18 years old
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Pathological complete remission rate (pCR) | after pathological examination of surgical speciments (6-8 weeks after chemoradiation) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events (according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE) | during preoperative treatment and after surgery for 5 years | Acute toxicities will be assessed every week during chemoradiation period , one week before surgery(6 weeks after chemoradiation) and every 3 months after surgery for 2 years.Late toxicities will be assessed every 6 months from the 3rd year for 3 years.Adverse eventswill be evaluated according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE) |
Other
| Measure | Time frame | Description |
|---|---|---|
| • Disease-free survival | 3 year afte concurrent chemoradiation | Followup will be done every 3 months in first 2 years, and every 6 months after 2 years. |
Countries
China
Contacts
Primary ContactJing Jin, Professor
Backup ContactHua Ren, Attending
Outcome results
None listed