A study to evaluate a chemotherapy treatment followed by chemo and radiotherapy in patients with rectal cancer
- Conditions
- Rectal cancerMedDRA version: 20.0Level: PTClassification code 10038038Term: Rectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-002095-40-ES
- Lead Sponsor
- Fundación de investigación de HM Hospitales
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
1. Male or females, aged > or = 18 years.
2. Agree to participate and sign voluntary written ICF before any study specific
procedure.
3. Patients with confirmed histopathological diagnosis of rectal cancer.
4. Patients with locally advanced rectal cancer T3-T4N0M0 or TxN+M0 and selected T2N0M0 candidates to watch & wait program.
5. Patients considered for neoadjuvant treatment according to usual clinical practice
may also be potential candidates.
6. ECOG performance status 0 or 1.
7. Patients who can receive radiotherapy and chemotherapy.
8. No prior or concurrent malignant disease unless in complete remission for more
than three years, except for adequately treated in situ carcinoma of the cervix, basal
or squamous skin cell carcinoma or in situ transitional bladder cell carcinoma.
9. Women of childbearing potential (WOCBP) must have a negative serum pregnancy
test before study entry. Both women and men must agree to use a highly effective
contraceptive measure throughout the treatment period and for six months after
discontinuation of treatment.
10. Adequate hematologic function
11. Adequate hepatic function
12. Adequate renal function
13. No peripheral neuropathy (< Grade 2)
14. No known history of dihydropyrimidine dehydrogenase deficiency (DPD)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2
1. Patients with ECOG performance status > or =2.
2. T1N0M0)or stage IV (TxNxM1) AJCC rectal cancer.
3. Any illness that the investigator considers will substantially increase the risk if the
patient participates in the study.
4. Pregnant or breast-feeding woman.
5. Chronically active hepatitis B or C virus infection.
6. Active uncontrolled infection.
7. History, within last year, or presence of unstable angina, myocardial infarction,
symptomatic congestive heart failure or asymptomatic left ventricular ejection
fraction < 50% (assessed by multiple-gated acquisition scan or equivalent by
ultrasound) or clinically significant valvular heart disease.
8. Peripheral neuropathy (> Grade 1)
9. Known history of dihydropyrimidine dehydrogenase deficiency (DPD)
10. Known or suspected reactions to any component of the study medication (5-FU,
leucovorin, irinotecan or oxaliplatin) or to components of similar chemical or
biologic composition.
11. Any phycological, familiar, sociological or geographical condition potentially
hampering compliance with the study protocol or follow-up schedule.
12. Concurrent participation in any other clinical trial likely to interfere with the
therapeutic schedule.
13. Patients that had received any previous treatment for their rectal cancer (surgery,
chemotherapy or radiotherapy).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method