Know Cancer

or
forgot password

Phase II Randomized Trial of Neoadjuvant Chemotherapeutic Treatment (XELOX) Followed by Chemoradiotherapy (XELOX/RT) and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk Rectal Cancer


Phase 2
18 Years
75 Years
Not Enrolling
Both
Rectal Neoplasms

Thank you

Trial Information

Phase II Randomized Trial of Neoadjuvant Chemotherapeutic Treatment (XELOX) Followed by Chemoradiotherapy (XELOX/RT) and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk Rectal Cancer


Inclusion Criteria:



- Patients with rectal adenocarcinoma.

- Operable tumour, confirmed by magnetic resonance of high resolution and / or
endorectal echography, or,

- Rectal tumour at distal third, or

- Tumours spread more than 5 mm in perirectal fat

- Functional state ECOG ≤ 2.

- Good hematological, hepatic and renal function

Exclusion Criteria:

- Previous pelvis radiotherapy.

- Previous antitumoural chemotherapy

- Pregnant or breastfeeding women.

- Childbearing women with a positive pregnancy test result at baseline. Menopausal
women should not have the period for the last 12 months.

- History of any other neoplastic illness within the last 5 years, except for already
resolved small cell skin cancer or cervix cancer.

- Clinically significant cardiovascular disease

- Confirmed peripheral neuropathy.

- Gastrointestinal disorders or bad absorption syndrome or non-capable to take oral
medication.

- Blood disorders.

- Intercurrent non-controlled or severe infections.

- Patients who have undergone major surgery, open biopsies or with significant trauma
lesions within the previous 28 days.

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.

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:

Response rate

Outcome Time Frame:

from the signature of Informed Consent up to the end of the study

Safety Issue:

No

Principal Investigator

José Mª Taboada, Dr.

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Spain: Spanish Agency of Medicines

Study ID:

PM_L_0098

NCT ID:

NCT00421824

Start Date:

May 2006

Completion Date:

November 2010

Related Keywords:

  • Rectal Neoplasms
  • Neoplasms
  • Rectal Neoplasms

Name

Location