Optimization of Preoperative Treatment in Locally Advanced Rectal Cancer
Optimization of Preoperative Treatment in Locally Advanced Rectal Cancer
The purpose of this study is to compare effectiveness of short-term radiotherapy with
 neoadjuvant chemotherapy(Experimental group) with preoperative long-term
 chemoradiotherapy(Control group) in locally advanced rectal cancer. The hypothesis is 3-year
 disease-free survival in Experimental group was non-inferior to that in Control group.
The study is a prospective phase II/III randomized multicenter trial. The purpose of this
 study is to compare short-term radiotherapy with neoadjuvant chemotherapy(Experimental group)
 with preoperative long-term chemoradiotherapy(Control group) for middle-lower locally
 advanced rectal cancer. The primary endpoint is 3-year disease-free survival, and the
 secondary objectives are 3-year local recurrence-free survival, distant metastasis-free
 survival and overall survival. Furthermore, the late toxicity profile and quality of life
 (QoL) after 3 years follow-up are secondary endpoints. For each group, a plan for collection
 of serum/plasma/feces at different stages of treatment and for obtaining fresh tumor tissue
 for freezing prior to treatment was defined in the protocol.

 The STELLAR-trial has been designed by National Cancer Center/Cancer Hospital, Chinese
 Academy of Medical Sciences, Peking Union Medical College, and the hypothesis is 3-year
 disease-free survival in Experimental group was non-inferior to that in Control group.
Inclusion Criteria:

 -  Biopsy proven rectal adenocarcinoma;

 -  Distance between tumour and anal verge≤ 10cm;

 -  Locally advanced tumour;(AJCC Cancer Staging:T3, T4 or N+)

 -  Cancer Staging must be based on pelvic MRI;

 -  Eastern Cooperative Oncology Group(ECOG) performance score ≤ 1;

 -  Written informed consent;

 -  Mentally and physically fit for chemotherapy;

 -  Adequate blood counts: White blood cell count ≥3.5 x 109/L Haemoglobin levels ≥100g/L
 Platelet count ≥100 x 109/L Creatinine levels ≤1.0× upper normal limit（UNL） Urea
 nitrogen levels ≤1.0× upper normal limit（UNL） Alanine aminotransferase(ALT) ≤1.5×
 upper normal limit（UNL） Aspartate aminotransferase(AST) ≤1.5× upper normal limit（UNL）
 Alkaline phosphatase(ALP) ≤1.5× upper normal limit（UNL） Total bilirubin(TBIL) ≤1.5×
 upper normal limit（UNL）

 -  No excision of tumor, chemotherapy or other anti-tumor treatment after the diagnosis.

 Exclusion Criteria:

 -  Distant metastases;

 -  Recurrent rectal cancer;

 -  Active Crohn's disease or ulcerative colitis;

 -  Concomitant malignancies;(except basocellular carcinoma or in-situ cervical carcinoma)

 -  Allergic to Fluorouracil or Platinum drugs;

 -  Contraindications to MRI for any reason;

 -  Concurrent uncontrolled medical condition;

 -  Pregnancy or breast feeding;

 -  Known malabsorption syndromes or lack of physical integrity of upper gastrointestinal
 tract;

 -  Symptoms or history of peripheral neuropathy