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


Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Rectal Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The rate of patients with R0 resection

Outcome Time Frame:

Surrogate endpoint available immediatly after surgery

Safety Issue:

No

Principal Investigator

Krzysztof Bujko, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roentgena 5, 02-781 Warsaw, Poland

Authority:

Poland: Ministry of Science and Higher Education

Study ID:

PGBRJG0109

NCT ID:

NCT00833131

Start Date:

November 2008

Completion Date:

November 2015

Related Keywords:

  • Rectal Cancer
  • Rectal cancer
  • Preoperative radiotherapy and consolidating chemotherapy
  • Rectal Neoplasms

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