Unique ID issued by UMIN | UMIN000002845 |
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Receipt number | R000003450 |
Scientific Title | Phase I Trial of S-1 and Weekly Oxaliplatin in Combination with Radiotherapy for Neoadjuvant Therapy of Locally Advanced Rectum Cancer |
Date of disclosure of the study information | 2009/12/04 |
Last modified on | 2015/09/19 14:50:47 |
Phase I Trial of S-1 and Weekly Oxaliplatin in Combination with Radiotherapy for Neoadjuvant Therapy of Locally Advanced Rectum Cancer
SOX-RT(P-I)
Phase I Trial of S-1 and Weekly Oxaliplatin in Combination with Radiotherapy for Neoadjuvant Therapy of Locally Advanced Rectum Cancer
SOX-RT(P-I)
Japan |
Rectal cancer of Stage II or III with T4 or lateral lymph node metastasis at the pre-operative diagnosis
Gastroenterology | Gastrointestinal surgery | Radiology |
Malignancy
NO
To determine dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD), and identify a feasible oxaliplatin dose for combination therapy of S-1 and concurrent radiation against stage II or III distal rectal cancer with T4 or lateral lymph node metastasis.
Safety
Exploratory
Explanatory
Phase I
the MTD and RD of oxaliplatin
Adverse events, radiologic and pathologic tumor response, surgical morbidity
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Maneuver |
1)S-1 at a dose of 80mg/m2/day orally in 2 divided doses for 5 days a week during radiotherapy
2) Weekly oxaliplatin at a dose of 40-60mg/m2 intravenously
3) Radiotherapy is delivered a total irradiation dose of 50.4 Gy given in daily fractions of 1.8 Gy, 5 days a week and additional exposure for 3 times.
4) Surgery
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1.Histologically confirmed Rectum cancer (adenocarcinoma, mucinous carcinoma, signet-ring cell carcinoma, adenosquamous carcinoma)
2. Preoperative findings (Must meet all the conditions)
i.Main lesion of the tumor is located at the Rs, Ra, Rb, or P
ii. Lower tumor margin is below the peritoneal reflection
iii. With lateral LN metastasis (internal iliac lymph nodes, obturator lymph nodes or common iliac lymph nodes (Shorter diameter of LN is less than 10 mm or more by pelvic CT or MRI)), or T4
3. No evidence of distant metastasis
4. age:20-75years old
5. ECOG PS:0 or 1
6. With or without target lesion by RECIST
7. Without prior anti-cancer therapy
8. Adequate oral intake
9. Adequate organ function
10.Written IC
1. Suspected metastasis of external iliac lymph nodes, para-aortic lymph nodes, or inguinal lymph nodes by pelvic MRI.
2. Prior or synchronous invasive malignancy (expect carcinoma in situ or superficial carcinoma which is able to eradicate by local therapy) unless disease free for a minimum of 5 years
3. Evidence of active bacterial or fungal infection (existing fever above 38 degrees centigrade due to infection)
4. Previous history of severe drug-induced allergy
5. Need to treatment with flucytosine, atazanavir sulfate, or warfalin
6. Need systemic administration of corticosteroids
7. Evidence of positive hepatitis B virus surface antigen
8. Evidence of severe watery diarrhea
9. Evidence of uncontrolled diabetic mellitus
10. Evidence of uncontrolled hypertension
11. Need to intervention for heart disease according to the findings of electrocardiogram within the last 28 days
12. Myocardial infarction or unstable angina pectoris within the last 12 months
13. Major surgery within 4 weeks of study enrollment (other than diverting colostomy)
14. Severe comorbidity (ie, bowel paralysis, bowel obstruction, interstitial pneumotitis, pulmonary fibrosis, advanced emphysema, heart disease which is difficult to manage, renal failure, hepatic failure)
15. Pregnant or lactating and woman with childbearing potential who lacked effective contraception
16. Evidence of psychiatric disability interfering with enrollment to clinical trial
17.Patients judged inappropriate for this study by the physicians
12
1st name | |
Middle name | |
Last name | Masayuki Ohue |
Osaka Medical Center for Cancer and Cardiovascular Diseases
Department of Surgery
1-3-3 Nakamichi, higashinari-ku, Osaka City, Osaka Prefecture
1st name | |
Middle name | |
Last name | Masayuki Ohue |
Osaka Medical Center for Cancer and Cardiovascular Diseases
Department of Surgery
ohue-ma@mc.pref.osaka.jp
National cancer center hosital
Ministry of Health, Labour and Welfare
Japan
NO
2009 | Year | 12 | Month | 04 | Day |
Published
Completed
2009 | Year | 11 | Month | 30 | Day |
2009 | Year | 12 | Month | 01 | Day |
2014 | Year | 05 | Month | 01 | Day |
2009 | Year | 12 | Month | 03 | Day |
2015 | Year | 09 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003450
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