A Trial of High Intensity Versus Low Intensity Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

An Open Label, Randomized, Multi-center, Phase II/III Trial of High Intensity Versus Low Intensity Neoadjuvant Chemoradiotherapy With Intensity-modified Radiation Therapy (IMRT) in Local Advanced Rectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01064999
• Other study ID #: FDRT-002
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: February 5, 2010
• Last updated: March 12, 2012
• Start date: March 2010
• Est. completion date: December 2014

Study information

• Verified date: March 2012
• Source: Fudan University
• Contact: Ji Zhu, MD
• Email: leo.zhu[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Neoadjuvant chemoradiotherapy (CRT) has been the standard therapy for local advanced rectal cancer. Pathological complete response (pCR) is an important prognostic factor for local control and survival. A high intensity CRT increases not only the pCR rate, but also toxicity, especially diarrhea. Compared with traditional RT technique, intensity-modified radiation therapy (IMRT) can decrease the toxicity of diarrhea because of low volume of high dose for small bowel. Therefore, IMRT technique provides an opportunity to improve the dose intensity of neoadjuvant CRT. The investigators hypothesize that a higher treatment dose induces a high rate of pCR and design a two-arm trial. in this trial, low intensity CRT includes the whole pelvic irradiation of 50Gy together with Oxaliplatin and Capecitabine weekly. While in high intensity group, additional concomitant 5Gy for primary tumor and a cycle of Xelox are prescribed. All patients will receive a total mesorectal excision (TME) 8 weeks after CRT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 2014
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with rectal adenocarcinoma

• Clinical staged T3/4 or any node-positive disease

• Age: 18-75 years

• Karnofsky Performance Status > 80

• Adequate bone marrow reserve, renal and hepatic functions

• Without previous antitumoural chemotherapy

• No evidence of metastatic disease

• Written informed consent before randomization

Exclusion Criteria:

• Previous pelvis radiotherapy.

• Previous antitumoural chemotherapy

• Clinically significant internal disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• Oxaliplatin
CRT:50mg/m2,IV,weekly*5 cycle CT: 130mg/m2,IV,d1,q 21 day
• Capecitabine
CRT:625mg/m2,bid,d1-5,q week RT:1000mg/m2,bid,d1-14,q 3 weeks

Radiation:
• Radiotherapy
High intensity group:55Gy Low intensity group:50Gy

Procedure:
• Surgery
Lower anterior resection or abdominoperineal resection

Locations

Country	Name	City	State
China	Cancer Hospital, Fudan University	Shanghai	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Fudan University	First Affiliated Hospital of Zhejiang University, RenJi Hospital, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of pathological complete response (pCR)		within 14days after surgery	No
Primary	toxicity		every week during radiotherapy	Yes
Secondary	local recurrence		every half year after surgery	No
Secondary	disease-free survival		every half year after surgery	No
Secondary	overall survival		every half year after surgery	No