RP II Study of SOX vs mFOLFOX6 in Patients With Resectable Rectal Cancer (KSCC1301).

Summary

To evaluate the efficacy and safety of SOX or mFOLFOX6 as neoadjuvant chemotherapy in patients with resectable rectal cancer, and to identify the more promising regimen.

Conditions

• Rectal Cancer

Interventions

OTHER

Laboratory test

Leukocyte, neutrophil (ANC ：stab + seg), hemoglobin, platlet, albumin, total birrilubin, AST, ALT, LDH, Creatinine, Na, K, CRP, fast blood sugar

OTHER

Medical history and physical examination

medical history and physical examination

OTHER

BW and height

Body weight (kg) and height (cm)

OTHER

Performance status

ECOG performance status, 0: Fully active, able to carry on all pre-disease performance without restriction, 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work, 2: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours, 3: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours, 4: Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair, 5: Dead

OTHER

Creatinine clearance

Creatinine clearance (CCr, mL/min) was estimated by Cockcroft \& Gault method using serum creatinine (mg/dL), age and body weight (kg).

OTHER

Biomarker

Carcinoembryonic antigen and carbohydrate antigen 19-9

RADIATION

Contrasting CT

Computed tomography

OTHER

Adverse event

AE was evaluated using Common Terminology Criteria for Adverse Events (CTCAE v4.0).

OTHER

HBs antigen and HCV antibody

check for exclusion criteria

OTHER

Endoscopy

Endoscopy for lower digestive tract

OTHER

HBs antibody and HBc antibody

Check according to hepatitis B guideline

DRUG

S-1

S-1 (80 mg/m2, p.o.) is administered at day 1 -14 of the course and repeated every 3 weeks until 4 courses or meet discontinuation criteria.

DRUG

L-OHP (130mg/m2)

L-OHP (130mg/m2 intravenously) is administered at day 1 of the course and repeated every 3 weeks until 4 courses or meet discontinuation criteria.

DRUG

L-OHP (85 mg/m2)

L-OHP (85mg/m2) is administered by IV infusion drip for 2hr at day 1 of the course and repeated every 2 weeks until 6 courses or meet discontinuation criteria.

DRUG

l-LV

l-LV (200 mg/m2) is administered by IV infusion drip for 2hr at day 1 of the course and repeated every 2 weeks until 6 courses or meet discontinuation criteria.

DRUG

5-FU

5-FU (400 mg/m2) by bolus IV administration just after the L-OHP and l-LV administration. 5-FU (2,400 mg/m2) by IV continuous infusion for 46 hours using infuser pump afterwards and repeated every 2 weeks until 6 courses or meet discontinuation criteria.

Sponsors & Collaborators

• Clinical Research Support Center Kyush

  lead OTHER

Principal Investigators

• Yasunori Emi, MD, PhD · Saiseikai Fukuoka General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-09-30

Primary Completion

2018-08-31

Completion

2020-08-31

Countries

• Japan

Study Locations