Patients with operable rectal cancer MedDRA version: 14.1 Level: PT Classification code 10062099 Term: Rectal neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: XELODA*120CPR RIV 500MG
Pharmaceutical Form: Tablet
INN or Proposed INN: CAPECITABINE
CAS Number: 154361-50-9
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg mil
Sponsors
CENTRO DI RIFERIMENTO ONCOLOGICO DI AVIANO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligibility criteria include 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 MRI or endoluminal ultrasound. Patients with unresectable mestastatic disease, with an ECOG performance status > 3 and patients not deemed fit for radiotherapy, capecitabine or surgery are excluded. Pregnant or lactating patients, women with child bearing potential who lack effective contraception and patients below 18 years old are excluded as well Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: - ECOG Performance status >3 - previous pelvic radiation therapy and/or chemotherapy - patients with inoperable rectal cancer - unresectable distant metastases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): we propose a randomized non-inferiority trial that compares preoperative FUbased chemoradiotherapy to radiotherapy with a simultaneous integrated boost. In case of non-inferiority, the latter approach is considered preferential with regard to toxicity and cost. The metabolic response of the tumor, as assessed by 18F-FDG PET or PET-CT, will be used as a surrogate marker of cause specific outcome.;Timepoint(s) of evaluation of this end point: 4-6 weeks after preoperative treatment;Main Objective: we propose a randomized non-inferiority trial that compares preoperative FUbased chemoradiotherapy to radiotherapy with a simultaneous integrated boost. In case of non-inferiority, the latter approach is considered preferential with regard to toxicity and cost. The metabolic response of the tumor, as assessed by 18F-FDG PET or PET-CT, will be used as a surrogate marker of cause specific outcome.;Secondary Objective: Secondary endpoints: ?? histological downgrading, according to the Dworak classification (13) ?? number of R0, R1 and R2 resections ?? acute and late toxicity, according the NCI Common Terminology Criteria for Adverse Events v3.0 (CTCAE) ?? local control ?? progression free survival ?? survival ?? quality of life ?? cost evaluation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Histological tumor regression grade;Timepoint(s) of evaluation of this end point: 6-8 weeks after preoperative treatment | — |
Countries
Italy
Contacts
Public ContactDr. Antonino De Paoli
Centro di Riferimento Oncologico (CRO), IRCCS, Aviano
Outcome results
None listed