The Randomised Study of Preoperative Radiotherapy With Consolidating Chemotherapy for Unresectable Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

Short-course Preoperative Radiotherapy With Consolidating Chemotherapy vs. Preoperative Chemoradiation in Patients With Unresectable Rectal Cancer: Phase III Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00833131
• Other study ID #: PGBRJG0109
• Status: Recruiting
• Phase: Phase 3
• First received: January 29, 2009
• Last updated: April 14, 2010
• Start date: November 2008
• Est. completion date: November 2015

Study information

• Verified date: April 2010
• Source: Polish Colorectal Cancer Study Group
• Contact: Wojciech Michalski, M. S.
• Phone: +48226433909
• Email: W.Michalski[@]coi.waw.pl
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial Summary

The addition of Oxaliplatin to conventionally fractionated chemoradiation (FULV or capecitabine) is considered as standard in unresectable rectal cancer by the panel of experts. The Investigators addressed the question whether short-course preoperative radiotherapy with consolidating chemotherapy of FOLFOX4 may increase the rate of R0 resection in patients with unresectable rectal cancer.

Description:

Patients with unresectable primary rectal cancer or with unresectable local recurrence without distant metastases are randomly allocated to control or experimental arm. The preoperative treatment in the control arm is conventionally fractionated chemoradiation with 50.4 Gy total dose in 28 fractions of 1.8 Gy over 5.5 weeks simultaneously with 5-Fu, leucovorin and oxaliplatin. Experimental group receive 25 Gy in 5 fractions of 5 Gy over 5 days and after one week interval - consolidating chemotherapy of 3 courses of FOLFOX4. Surgery should be curried out 10-11 weeks from beginning of radiation and at least 4 weeks from the last dose of fluorouracil or radiation. The study hypothesis is that the short-course preoperative radiotherapy with consolidating chemotherapy produce at least 10% increase of the rate of R0 resection compared to preoperative chemoradiation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: November 2015
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with unresectable primary rectal cancer or with unresectable local recurrence without distant metastases.

• WHO performance status = 2.

• Lower border of tumour = 15 cm from anal verge.

Exclusion Criteria:

• cardiac coronary arterial disease,

• arrhythmias,

• stroke even if they have occurred in the past and are controlled with medication

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

Radiation:
• Short course of radiotherapy
5 x 5 Gy and afer one week interval consolidating chemotherapy of 3 courses of FOLFOX4
• Radiochemotherapy
28 x 1,8 Gy with simultaneous neoadjuvant chemotherapy: two courses of 5-Fu 325 mg/m2/day i.v. bolus and LV 20 mg/m2/day i.v.-bolus over 5 days given during 1-5 and 29-33 days of radiation. Oxaliplatin is given 50 mg/m2 once a week 5 times during 1, 8, 15, 22 and 29 days of radiation.

Locations

Country	Name	City	State
Poland	M. Sklodowska-Curie Memorial Cancer Centre	Warsaw

Sponsors (5)

Lead Sponsor	Collaborator
Polish Colorectal Cancer Study Group	Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Cracow, Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology, Medical University of Lublin, Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Bujko K, Kolodziejczyk M. The 5 x 5 Gy with delayed surgery in non-resectable rectal cancer: a new treatment option. Radiother Oncol. 2008 Jun;87(3):311-3. doi: 10.1016/j.radonc.2007.12.020. Epub 2008 Jan 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of patients with R0 resection		Surrogate endpoint available immediatly after surgery	No
Secondary	Overall long-term survival		5 years	No
Secondary	Progression-free long-term survival		5 years	No
Secondary	The rate of local failures		5 years	No
Secondary	The rate of distant metastases		5 years	No
Secondary	The rate of early toxicity of neoadjuvant treatment according to the NCI CTCAE (version 3.0)		3 months	Yes
Secondary	The rate of postoperative complications		30 days	Yes
Secondary	The rate of late toxicity according to the RTOG/EORTC scale		5 years	Yes
Secondary	The rate of complete pathological response		Surrogate endpoint available immediatly after surgery	No