Evaluation of the Neoadjuvant Treatment With Oxaliplatin -UFT- Radiotherapy in Rectal Cancer

Sanofi

Status and phase: Completed; Phase 2; Phase 1

Conditions: Rectal Neoplasms

Treatments: Drug: OXALIPLATIN

Study type: Interventional

Funder types: Industry

Identifiers

NCT00403624

L_8128

Details and patient eligibility

About

Primary objective:

• To evaluate the rate of responses to neoadjuvant therapy + radiotherapy

Secondary objective:

• tolerability (toxicity) and time to progression

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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:

• Patients with measurable, histologically proven rectal cancer.
• No history of previous malignancy but adequately treated skin / cervical cancer.
• Adequate haematological, renal and liver function.

Exclusion Criteria:

• No cardiopulmonary insufficiency or coronary disease. No sensory neuropathy prior to study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)