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

Inoperable or Recurrent Rectal Cancer Clinical Trial

— TOMUDEX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00590278
• Other study ID #: 1694TR/01
• Status: Completed
• Phase: Phase 2
• First received: December 26, 2007
• Last updated: January 23, 2008
• Start date: August 2002

Study information

• Verified date: January 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Inoperable or Recurrent Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• Tomudex

Procedure:
• Radiotherapy

• Haematology

• Biochemistry

Locations

Country	Name	City	State
Turkey	Research Site	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	This study will evaluate the value of TOMUDEX in combination with a 'standard' course of pelvic radiotherapy for inoperable/recurrent rectal cancer, in terms of response rate and increasing the resectability rate