Evaluation of Efficacy, Quality of Life and Cost Effectiveness of Short-course Radiotherapy Followed by Capecitabine Plus Oxaliplatin chemotheRapy and TME for High-risk Rectal Cancer (ESCORT Trial)

Yonsei University31 enrolled

Overview

Multimodality treatment including surgery and radiotherapy is the current standard of care in locally advanced rectal cancer. Most clinical trials comparing short course radiotherapy (SCRT) with long course chemoradiotherapy(LCRT) did not find significant differences in oncological outcomes and short-term outcomes even though some debates. Recently, Stockholm III trial comparing SCRT plus delayed surgery with SCRT plus immediate surgery and LCRT demonstrated no differences with respect to short-term outcomes such as complications, mortality, and acute toxicity. However, overall quality of life (QoL) after curative treatment for rectal cancer is still major concern in both SCRT and LCRT. Furthermore, daily hospital visits for 5 weeks may be the cause of the increase of total medical cost due to indirect medical expense in patients with LCRT, especially in rural area. SCRT plus chemotherapy followed by delayed surgery may have the possibility of reducing total hospital costs as well as increasing QoL by proving non-inferiority in terms of perioperative outcomes. The present prospective single-arm phase 2 trial was designed to validate the efficacy, quality of life and cost effectiveness of preoperative short-course radiotherapy plus XELOX chemotherapy followed by delayed surgery for high-risk rectal cancer patient based on magnetic resonance imaging.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Locally Advanced Rectal Cancer

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. High-risk patients of rectal cancer on pretreatment MRI using the following risk stratification system Location of the lower part of the tumor is measured below less than 10 cm on the anal verge and lower part of the tumor is located below the lower limit of the peritoneal reflection. If there is more than one, classify as a high risk group Positive CRM threatening: 5mm ≦ Extramural depth Positive EMVI. cN2: Positive Lateral pelvic LN metastasis 2. Between 19 and 80 years of age; 3. Satisfactory performance status: ECOG≦2 4. American Society of Anesthesiologists (ASA) physical status classification system class I\~III 5. Adequate hematologic function: white blood cell(WBC) counts≥4,000/mm3, neutrophils counts ≥ 1,500/mm3, platelet counts ≥ 100,000/µL, hemoglobin ≥ 9g/L; 6. Adequate renal function: creatinine ≤ 1.5×upper normal limit Exclusion Criteria: 1. The evidence of relapse of distant metastasis 2. Receiving treatment of other anti-cancer drug or methods 3. Patients have low compliance and are not able to complete the entire trial 4. Presence of uncontrolled life-threatening diseases 5. cT4 with infiltration of anterior organ on pretreatment MRI 6. cT4 with infiltration of internal or external anal sphincter on pretreatment MRI

Outcomes

Primary Outcomes

pathologic complete response (pCR) rate

According to pathological response criteria, a total regression is considered a complete response

Time frame: Two weeks after surgery

Secondary Outcomes

Incidence of acute toxicities during radiation and chemotherapy

Time frame: Three months

Incidence of surgical complications

Time frame: Four weeks after surgery

Quality of life

QOL assessed using EORTC QLQ-CR29 survey form. The EORTC QLQ-CR29 is a 29-item colon and rectum cancer site-specific supplemental module that aims to enhance the sensitivity and specificity for colorectal cancer quality of life measures. The original English version comprises 4 multi-item scales (body image, urinary frequency, blood and mucus in stool, and stool frequency) and 17 functional/symptomatic single-items(anxiety, weight, sexual interest, urinary incontinence, dysuria, abdominal pain, buttock pain, bloating, dry mouth, hair loss, taste, flatulence, fecal incontinence, sore skin, embarrassment, stoma care problem, impotence or dyspareunia), with higher scores indicating better functional or worse symptomatic status. Of these 21 scales or items, only body image, anxiety, weight, and sexual interest are functional domain scales/items, and all the remaining are symptomatic.

Time frame: Baseline and QOL at 8 weeks after radiotherapy

Cost effectiveness

QALYs (quality adjusted life years) with treatment protocol