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

Fudan University logo

Fudan University

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Rectal Cancer

Treatments

Radiation: Radiotherapy
Drug: Capecitabine
Drug: Oxaliplatin
Procedure: Surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT01064999
FDRT-002

Details and patient eligibility

About

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.

Enrollment

240 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

240 participants in 2 patient groups

High intensity group
Experimental group
Description:
(RT 55Gy + CapOx) + a cycle of Xelox + Surgery
Treatment:
Drug: Oxaliplatin
Radiation: Radiotherapy
Drug: Capecitabine
Procedure: Surgery
Low instensity group
Active Comparator group
Description:
(RT 50Gy + CapOx) + Surgery
Treatment:
Drug: Oxaliplatin
Radiation: Radiotherapy
Drug: Capecitabine
Procedure: Surgery

Trial contacts and locations

1

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Central trial contact

Ji Zhu, MD

Data sourced from clinicaltrials.gov

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