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


Phase 2
18 Years
N/A
Not Enrolling
Both
Inoperable or Recurrent Rectal Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Principal Investigator

Tayfun Hancilar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Okmeydani Hospital Istanbul

Authority:

Turkey: Ministry of Health

Study ID:

1694TR/01

NCT ID:

NCT00590278

Start Date:

August 2002

Completion Date:

Related Keywords:

  • Inoperable or Recurrent Rectal Cancer
  • Tomudex
  • inoperable rectal cancer
  • recurrent rectal cancer
  • Rectal Neoplasms

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