Locally Advanced Rectal Cancer
Conditions
Keywords
neoadjuvant chemoradiotherapy, irinotecan, SN-38
Brief summary
The study evaluates the associations between peak and valley concentrations of SN-38 with the efficacy and adverse effects of advanced rectal cancer patients carrying genotype (TA) 6 /(TA) 6 or (TA) 6 /(TA) 7 after neoadjuvant chemoradiotherapy with CPT-11.All participants will be scheduled to receive surgery 6-8 weeks after the completion of CRT. The primary end point are toxicity and pCR rate.
Interventions
DIAGNOSTIC_TESTBlood concentration check
Blood concentration check：the plasma concentration of SN-38 was detected by HPLC (high-performance liquid chromatography) at 1.5 h and 49.0 h after CPT-11 infusion
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* pathological confirmed adenocarcinoma * clinical stage T3-4 and/or N+ * the distance from anal verge less than 12 cm * without distance metastases * performance status score: 0\ 1 * UGT1A1\*28 6/6 or 6/7 * without previous anti-cancer therapy * sign the inform consent
Exclusion criteria
* pregnancy or breast-feeding women * serious medical illness * baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN * DPD deficiency * UGT1A1\*28 7/7
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0 | During the chemoradiation weekly，assessed up to 5 weeks | the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0 |
| pathological response rate | Surgery scheduled 6-8 weeks after the end of chemoradiation | pathological complete response (pCR) was defined no viable cancer cell under the examination of surgical resection specimen. |
Countries
China
Contacts
Primary ContactJi Zhu, PhD
Outcome results
None listed