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Induction Chemotherapy, Preoperative Radiochemotherapy, Consolidation Chemotherapy, Operation and Adjuvant Chemotherapy in the Treatment of Locally Advanced Rectal Cancer- OIGIT 5-01 Phase II Trial


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Rectal Cancer

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Trial Information

Induction Chemotherapy, Preoperative Radiochemotherapy, Consolidation Chemotherapy, Operation and Adjuvant Chemotherapy in the Treatment of Locally Advanced Rectal Cancer- OIGIT 5-01 Phase II Trial


Inclusion Criteria:



- Male or female patients with histologically proven adenocarcinoma of the rectum
(tumour located below the peritoneum),

- T3/4 or any node positive disease (clinical stage according the TNM classification
system)

- No evidence of metastatic disease.

- The disease must be considered either resectable at the time of entry or thought to
become resectable after preoperative chemoradiation.

- Age 18 years and more

- WHO Performance Status 0-2

- No prior radiotherapy, chemotherapy or any targeting therapy for rectal cancer

- Adequate hematological, hepatic and renal function Ability to swallow tablets

- Signed informed consent

- Patients must be willing and able to comply with the protocol for duration of the
study

Exclusion Criteria:

- Malignancy of the rectum other than adenocarcinoma

- Any unrested synchronous colon cancer

- Other co-existing malignancy or malignancy within the past 5 years, with the
exception of adequately treated in situ carcinoma of the cervix or basal cell
carcinoma of the skin

- Significant heart disease (uncontrolled hypertension despite of medication (> 150/100
mmHg), NYHA class III or IV heart disease,unstable angina or myocardial infarction
within the past 1 year prior the study entry, history of significant ventricular
arrhythmia requiring treatment)

- Pregnant or lactating patient

- Females with a positive or no pregnancy test unless childbearing potential can be
otherwise excluded (amenorrheic for at least 2 years,hysterectomy or oophorectomy)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Pathological complete remission rate (pCR)

Outcome Time Frame:

after the pathological examination of surgical speciments ie within 14 days after the operation

Safety Issue:

No

Principal Investigator

Vaneja Velenik, Prof.assist

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institute of Oncology Ljubljana, Slovenia

Authority:

Slovenia: Ethics Committee

Study ID:

163/06/11

NCT ID:

NCT01489332

Start Date:

October 2011

Completion Date:

April 2018

Related Keywords:

  • Rectal Cancer
  • rectal cancer
  • capecitabine
  • radiotherapy
  • locally advanced rectal cancer
  • Rectal Neoplasms

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