Locally Advanced Rectal Cancer
Conditions
Keywords
Neoadjuvant Chemoradiation, Irinotecan, UGT1A1
Brief summary
The study evaluate the addition of Irinotecan in neoadjuvant chemoradiation. Half of participants will receive capecitabine alone together with neoadjuvant CRT, followed by a cycle of XELOX, while the other will receive capecitabine and irinotecan during CRT, followed by a cycle of XELIRI. All participants will be scheduled to receive surgery 6-8 weeks after the completion of CRT, then 5 cycles of adjuvant chemotherapy of XELOX.
Interventions
RADIATIONRadiation
Pelvic Radiation: 50Gy/25Fx
DRUGCapecitabine
DRUGIrinotecan
DRUGOxaliplatin
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Hubei Cancer Hospital
First Affiliated Hospital of Chongqing Medical University
Ruijin Hospital
Fudan University
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
* pathological confirmed adenocarcinoma * clinical stage T3-4 and/or N+ * the distance from anal verge less than 12 cm * without distance metastases * KPS \>=70 * 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 |
|---|---|
| Pathologic Complete Response | Surgery scheduled 6-8 weeks after the end of chemoradiation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From date of randomization until the date of death from any cause, assessed up to 10 years | — |
| Disease-free Survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 years | — |
| Local Control rate | From date of randomization until the date of first documented pelvic failure, assessed up to 10 years | Number of participants with pelvic failure after surgery, evaluated using Kaplan-Meier Curve |
| Number of participants with chemoradiation-related adverse events as assessed by CTCAE v4.0 | Up to 2 years | — |
| Surgical complications | Surgery scheduled 6-8 weeks after the end of chemotherapy | — |
Countries
China
Outcome results
None listed