Phase II study of up-front chemotherapy and neo-adjuvant short-course radiotherapy for resectable rectal carcinoma

Phase 1

• Conditions: resectable rectal carcinoma; MedDRA version: 15.1 Level: LLT Classification code 10038052 Term: Rectal carcinoma System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-000770-30-IT
• Lead Sponsor: IRCCS ISTITUTO SCIENTIFICO ROMAGNOLO PER LO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-12
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1.Patients with histologically or cytologically confirmed diagnosis of adenocarcinoma of the mid-low rectum (within 12 cm from the anal verge)
2.Stage: lowT2N0, T2N+M0, T3-4 N-/+M0 (N+ = = 3 nodes >0,5 cm diameter or = 1 nodes > 1 cm diameter)
3.Age =18 and = 80 years
4.ECOG performance status 0-1
5.Patients must have normal organ and marrow function as defined below:
a.- Leukocytes = 3,000/?L
b.- Absolute neutrophil count = 1,500/?L
c.- Platelets = 100,000/?L
d.- Total bilirubin = 1.5 X ULN
e.- AST (SGOT)/ALT (SGPT) = 2.5 X ULN
f.- Creatinine = 1.5 X ULN
6.Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
7.Participant is willing and able to give informed consent for participation in the study.

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 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1.Metastatic disease
2.Patients who have had any chemotherapy or radiotherapy prior to entering the study
3.Acute or sub-acute gastrointestinal occlusion
4.Participation in another clinical trial, with any investigational agent within 30 days prior the study screening
5.Other known malignant neoplastic diseases in the patient’s medical history with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma, superficial bladder tumor and in situ carcinoma of the uterine cervix)
6.History of allergic reactions attributed to compounds of similar chemical or biological composition to drugs used in the study
7.Uncontrolled concomitant illness, including but not limited to: ongoing or active infections; congestive heart failure; unstable angina pectoris; cardiac arrhythmia; or psychiatric illness/social situations that would limit compliance to study requirements

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified