UnknownPhase 2

Neo-adjuvant Chemoradiotherapy Using Infusional Gemcitabine Followed by Surgery for Locally Advanced Rectal Cancer

Saudi Arabia25 participantsStarted 2014-12

Plain-language summary

Phase II Study of Neo-adjuvant Chemoradiotherapy using infusional Gemcitabine followed by Surgery for Locally Advanced (T3 and T4 or Node positive) Rectal Adenocarcinoma.

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. Adenocarcinoma of the rectum without evidence of distant metastases
✓. Patient must be 18 years of age or greater
✓. Potentially resectable disease based upon surgeons evaluation
✓. Clinical stages T3 or T4a, and/ or positive nodes based upon endorectal ultrasound and/ or MRI.
✓. Absolute neutrophil count of \> 1500 per microliter and platelet count \> 100,000 per microliter; Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and alkaline phosphatase \< 2.5 X upper limit of normal (ULN), bilirubin \< = 1.5 ULN, calculated creatinine clearance \> 50 ml/min using Cockcroft-Gault formula:
✓. Eastern cooperative oncology group (ECOG) performance status 0-2
✓. No history of other malignancies within 5 years, except non-melanoma skin cancer, in situ carcinoma of the cervix, or ductal carcinoma in situ of the breast. Previous invasive cancer permitted if disease free at least 5 years.
✓. Signed study-specific informed consent prior to enrolment

Exclusion criteria

✕. Any evidence of distant metastasis
✕. Synchronous primary colon carcinomas, except T1 lesions (full colonoscopy not required for enrollment)
✕. Extension of malignant disease to the anal canal
✕. Prior radiation therapy to the pelvis
✕. Prior chemotherapy for malignancies
✕. Pregnancy or lactation, (exclusion due to potential adverse effects of therapy). Women of childbearing potential with either a positive or no pregnancy test (serum or urine) at baseline. Women/men of childbearing potential not using a reliable and appropriate contraceptive method. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered to be of non-childbearing potential.) Patients will agree to continue contraception for 30 days from the date of the last study drug administration.
✕. Serious, uncontrolled, concurrent infection(s).
✕. Participation in any investigational drug study within 4 weeks preceding the start of study treatment

What they're measuring

Estimate the rate of pathological complete response following neoadjuvant combined-modality therapy using weekly Gemcitabine and radiation therapy in rectal cancer.

Timeframe: "3 years"

Trial details

NCT IDNCT02919878

SponsorKing Faisal Specialist Hospital & Research Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12

Contact for this trial

Shouki Bazarbashi, MD

00966 11 442 3935 bazarbashi@kfshrc.edu.sa

View on ClinicalTrials.gov More Rectal Adenocarcinoma trials