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A study of S-1 with radiation therapy with local advanced colorectal cancer

A study of S-1 with radiation therapy with local advanced colorectal cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002240
Enrollment
Unknown
Registered
2012-05-02
Start date
2012-05-05
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rectal cancer

Interventions

1:different drug
2:S1 capsule

Sponsors

Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Between 8 to 70 years old, both genders; 2. More than 6 month life can be expected; 3. Pathology proved confirmed rectal cancer ,and invasion layer is more than T2; 4. No remote metastasis; 5. evaluation of tumor by CT and MRI before the radiation; 6. Eastern Co-operative Oncology Group score is between 0-2; 7. No radiation therapy, chemotherapy, target therapy, immunity therapy in 6 month; 8. No chronic disease out of the control; 9. The function of organ is as follow: AST ALT ALP =2.0*10^9/L; blood platelet count>=100*10^9/L; hemoglobin>=90g/L; Serum creatinine =60 mL/min; 10. Heart function is good, no myocardial infraction in 6 month, hypertension and coronary heart disease is under control; 11. exclude the other treatment programme; 12. signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactational patient; 2. The women who has plan to pregnancy in near future; 3. Do not fit the standard; 4. Liver or kidney severe disease or heart Failure; 5. Nervous disease or psychiatric history include dementia and epilepsy; 6. coronary heart disease; 7. arrhythmia need the medicine treatment; 8. Hypertension cannot under control (diastolic pressure over 90mmhg); 9. Severe infections; 10. HIV infected; 11. Central Nervous System Neoplasms; 12. Gastric and intestine bleeding in 6month; 13. Over use the medicine .the patient may be influenced by the medical psychological and social enviroment; 14. Patient cannot take the medicine orally; 15. Any unstable condition may jeopardize the safety of patient his/her compliance; 16. other tumor history; 17. Remote organ metastasis; 18. accepted the operation in past 3 month; 19. Basic condition too bad to sustain the operation; 20. accepting other treatment programme; 21. Allergy to the chemical medicine.

Design outcomes

Primary

MeasureTime frame
R0 rate;anus reservation;

Countries

China

Contacts

Public ContactZhang Wei
jefershon@163.com+86 13701939544

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026