A Phase-II Study Of TOMUDEX Plus Radiotherapy In Subject With Inoperable or Recurrent Rectal Cancer

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Inoperable or Recurrent Rectal Cancer

Treatments: Procedure: Biochemistry; Procedure: Radiotherapy; Drug: Tomudex; Procedure: Haematology

Study type: Interventional

Funder types: Industry

Identifiers

NCT00590278

1694TR/01

Details and patient eligibility

About

The pilot study is designed to investigate the value of Neo-adjuvant Tomudez in combination with radiotherapy in patients with inoperable or recurrent rectal cancer in terms of response rate and increasing the resectability of initially inoperable rectal cancer.

Enrollment: 49 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of inoperable/recurrent rectal cancer
• Age > 18 years
• At least 1 measurable lesion should be present
• WHO performance score < 2
• Life expentancy of at least 12 weeks
• Subjects will be considered appropriate to receive systemic chemotherapy and pelvic radiotherapy
• Documented informed consent to participate in the trial

Exclusion criteria

• Previous systemic chemotherapy
• Previous radiotherapy to the planned exposure area
• Subjects with distant metastases
• (a)white blood cell < 4.0x109/L (unless absolute neutrophil count is >2.0x109/L or (b) Platelet count < 100x109/L
• Serum creatinine above the upper limit of the normal range
• (a) Serum bilirubin > 1.25 times the upper limit of the normal range or (b) Asparate aminotransferase(AST) or Alanine amiontransferase (ALT) >2.5 times the upper limit of the normal range
• Any severe concurrent medical condition which would make it undesirable, in the clinician's opinion, for the patient to participate in the trial or which would jeopardise compliance with the trial period
• Pregnancy or breast feeding. Women of childbearing age must use effective contraception
• Previous or current malignancies at other sites, with the exception of adequately treated in-situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin
• Patient participation in other studies

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)