Clinical study of changing dose fractionation patterns of preoperative intensity-modulated radiotherapy (IMRT) in locally advanced rectal cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-ONC-12002387

Enrollment

Unknown

Registered

2012-08-01

Start date

2012-02-01

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

Case series:Patients will received capecitabine (825 mg/m2, bid d1-5 weekly) and SIB-IMRT delivering 58.75 Gy/25F (2.35Gy/fraction) to the gross tumor and regional transforming lymph nodes while simul

(to be continued):One cycle of capecitabine (1250 mg/m2, twice daily, d1-14) was given one week after the completion of chemoradiation(CRT), and total mesorectal excision was scheduled 6 to 8 weeks af

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. All patients should sign an institutional review board (IRB) approved consent form; 2. Irrespective of sex, patient should be between 18 and 75 years; 3. Pathologically confirmed resectable adenocarcinoma of clinical stage II or III by pelvic magnetic resonance imaging (MRI); 4. Primary tumor is less than 15 cm from the anal verge excluding the anal canal; 5. With a Karnofsky performance status of at least 70% and expected survival of longer than 6 months; 6. Requirements of the following biochemical tests: hemoglobin concentration>=11 g/dl, WBC count>=3.5*10^9/L, neutrophil count>=1.5*10^9/L, platelet count>=100*10^9/L, creatinine<=1.0*upper normal limit, total bilirubin<=1.0*upper normal limit, ALT and/or AST<=1.5*upper normal limit, AKP<=2.5*upper normal limit.

Exclusion criteria

Exclusion criteria: (1) Patients with systemic metastases; (2) Prior pelvic radiotherapy or prior chemotherapy; (3) Serious comorbidities such as hypertension, coronary heart disease, history of mental illness or severe allergies; (4) Refused or unable to sign an institutional review board(IRB)approved consent form; (5) With expected survival of less than 6 months.

Design outcomes

Primary

Measure	Time frame
Pathological complete response rate (ypCR);tumor down-staging;Acute toxicity and postoperative complication;	—

Secondary

Measure	Time frame
local recurrence rate;progression-free survival (PFS);overall survival (OS);Sphincter preserving rate;	—

Countries

China

Contacts

Public ContactLinchun Feng

tonifeng@yahoo.cn+86 15910926073

Outcome results

None listed

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