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Phase II study of preoperative Intensity-Modulated Radiotherapy(IMRT)and capecitabine in locally advanced cectal cancer

Phase II study of preoperative Intensity-Modulated Radiotherapy(IMRT)and capecitabine in locally advanced cectal cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-13004082
Enrollment
Unknown
Registered
2013-12-13
Start date
2014-01-01
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

1:Preoperative IMRT (pGTV 55Gy/25 fractions, PTV 45 Gy/5, Chemotherapy: oral capecitabine 825g/m2 per day, twice a day from day 1 to day 14
after 6 to 8 weeks of radiotherapy, conduct TME surgery

Sponsors

Jinhua Municipal Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. patients with histologically proven adenocarcinoma of the rectum, T3/4 or any node positive disease; 2. No evidence of metastatic disease; 3. Aged between 18 to 75 years old; 4. More than 6 month life can be expected; 5. Eastern Co-operative Oncology Group score is between 0-2; 6. No prior radiotherapy, chemotherapy or any targeting therapy for rectal cancer; 7. Normal hematological, hepatic and renal function; 8. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Uncontrolled medical disease; 2. Those patients who do not agree to participate in this study; 3. Pregnant or lactating woman; 4. Medical history of chronic diarrhea or inflammatory disease of the colon or rectum; 5. Other malignant tumours within the last 5 years except basal cell carcinoma of the skin.

Design outcomes

Primary

MeasureTime frame
Toxicity during chemoradiation;Pathological downstaging rate;Ro resection rate;Sphincter preserving rate;Surgical complication;

Countries

China

Contacts

Public ContactShubo Ding

Department of Radiation Oncology, Jinhua Municipal Central Hospital

jhyyys@163.com+86 13750983285

Outcome results

None listed

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