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

NCT00590278 | Completed Phase 2

• 1 other identifier: 1694TR/01
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inoperable or Recurrent Rectal Cancer

Keywords

Tomudex; inoperable rectal cancer; recurrent rectal cancer

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Tomudex DRUG

Radiotherapy PROCEDURE

Haematology PROCEDURE

Biochemistry PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

raltitrexed; Radiotherapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Tayfun Hancilar, MD

  Okmeydani Hospital Istanbul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 10, 2008
• Study Start: August 1, 2002
• Last Updated: January 25, 2008

Record last verified: 2008-01

Locations

TU (1)