Inoperable or Recurrent Rectal Cancer
Conditions
Keywords
Tomudex, inoperable rectal cancer, recurrent rectal cancer
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.
Interventions
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 | — |
Countries
Turkey (Türkiye)
Outcome results
None listed