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Phase I-II Study of Preoperative Oxaliplatin-FU and Radiotherapy for Patients With Rectal Cancer


Phase 1/Phase 2
18 Years
80 Years
Not Enrolling
Both
Rectal Neoplasms

Thank you

Trial Information

Phase I-II Study of Preoperative Oxaliplatin-FU and Radiotherapy for Patients With Rectal Cancer


The following information on clinical trials is provided for information purposes only to
allow patients and physicians to have an initial discussion about the trial. This
information is not intended to be complete information about the trial, to contain all
considerations that may be relevant to potential participation in the trial, or to replace
the advice of a personal physician or health professional.

Main criteria are listed hereafter:

Inclusion Criteria:



- ECOG: 0-2

- Histological proved rectal adenocarcinoma

- No chemotherapy treatment on the previous 6 months before inclusion.

- No previous pelvic radiotherapy treatment

Exclusion Criteria:

- Important Biological abnormality (renal, hepatic and/or hematological)

- Intestinal occlusion or subocclusion

- Peripheral neuropathy

- Pregnant or breast-feeding women. Potential child-bearing women with a positive
pregnancy test.

- Participation in other trials on the previous 4 months.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I : Maximum Tolerated Dose & Recommended Dose

Outcome Time Frame:

Days 1, 15, 29

Safety Issue:

No

Principal Investigator

José Mª Taboada

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Spain: Spanish Agency of Medicines

Study ID:

L_8330

NCT ID:

NCT00259363

Start Date:

October 2002

Completion Date:

Related Keywords:

  • Rectal Neoplasms
  • Neoplasms
  • Rectal Neoplasms

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