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Preoperative Concurrent Boosting Intensity-Modulated Radiotherapy with Oral Capecitabine in Locally Advanced Mid-Low Rectal Cancer

Preoperative Concurrent Boosting Intensity-Modulated Radiotherapy with Oral Capecitabine in Locally Advanced Mid-Low Rectal Cancer

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-TNC-10001094
Enrollment
Unknown
Registered
2010-11-22
Start date
2007-05-10
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 (GTV 50.6Gy/22 fractions, CTV 41.8 Gy/22 frations, the boost to the primary tumor would be administered synchronously with the whole pelvis) with concurrent capecitabine 825 mg/m2

Sponsors

Beijing Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: All patients were histologically confirmed as the rectal adenocarcinoma within 10 cm from the anal verge, with no evidence of distant metastases. The T/N situation was stage T3 to T4 with any N, or any T with N1 to N2. Patients presenting with T2N0 tumors located within 5 cm from the anal verge could also be included.The age for this trial defined as between 18-75 years old. Patients were also required to have a WHO performance status of 0 or 1 with adequate liver, kidney, and bone marrow function.

Exclusion criteria

Exclusion criteria: Patients who had prior history of chemotherapy or pelvic radiation therapy were excluded. Patients with a history of other malignancy were also excluded. Other exclusion criteria included the acute obstructive symptoms,unresectable disease, sensitivity to fluoropyrimidines, and any serious conditions not suitable for chemoradiotherapy.

Design outcomes

Primary

MeasureTime frame
Toxicity during chemoradiation;

Secondary

MeasureTime frame
Local recurrence, Distant metastases,Overall survival;

Countries

China

Contacts

Public ContactYong Cai
caiyong109@sohu.com+86 13691351813

Outcome results

None listed

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