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

Study Overview
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Brief Summary
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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.

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

Conditions
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Inoperable or Recurrent Rectal Cancer

Intervention / Treatment
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* Drug: Tomudex
* Procedure: Radiotherapy
* Procedure: Haematology
* Procedure: Biochemistry


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tomudex|nan|
|Procedure: Radiotherapy|nan|
|Procedure: Haematology|nan|
|Procedure: Biochemistry|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tomudex, inoperable rectal cancer, recurrent rectal cancer