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Simultaneous integrated boost versus regular intensity-modulated radiation therapy in the preoperative?concurrent chemoradiotherapy?of locally advanced recta

Simultaneous integrated boost versus regular intensity-modulated radiation therapy in the preoperative?concurrent chemoradiotherapy?of locally advanced recta

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800018750
Enrollment
Unknown
Registered
2018-10-07
Start date
2015-01-01
Completion date
Unknown
Last updated
2018-10-15

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

Conditions

rectal cancer

Interventions

SIB-IMRT group:SIB-IMRT technology for neoadjuvant synchronous chemoradiotherapy
R-IMRT group:Conventional segmented radiotherapy for neoadjuvant concurrent chemoradiotherapy

Sponsors

The First Affiliated Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. histopathological confirmation of rectal adenocarcinoma; 2. aged 18-75 years; 3. The survival period is estimated to be over 6 months; 4. resectable tumor distal border located within 10cm from anal verge; 5. pre-treatment tumor staging cT3-4 or N+ without distant metastatic disease; 6. without any chemotherapy history or abdominal and pelvic radiotherapy history; 7. the white blood cell count=3.5x109/L, the hemoglobin count=11g/dl; the platelet count=100x10^9/L; 8. adequate liver function and renal function (bilirubin and AST or ALT; creatinine must be=1.5 times upper normal limit); 9. all patients must consent to be in the study.

Exclusion criteria

Exclusion criteria: Except adenocarcinoma, the malignant rectal tumor such as sarcoma, lymphoma, carcinoid were excluded. Patients must not have other previously cancer and previously receive chemotherapyradiotherapy to the pelvis, or have contraindications to the CRT. 1. patients with distant metastasis; 2. systemic infections are not yet controlled; 3. chronic wasting diseases; 4. in pregnancy and lactation; 5. in chronic hormone or systemic immunotherapy; ) combined with severe hypertension, liver and kidney dysfunction, and abnormal bone marrow function; 6. History of radiotherapy and chemotherapy or other anti-tumor treatment (including immunotherapy) for other malignant tumors, combined with severe heart, liver, kidney and lung diseases; hereditary syndrome; 7. recurrent rectal cancer.

Design outcomes

Primary

MeasureTime frame
The tumor regression grading(TRG);T downstaging rate;

Secondary

MeasureTime frame
Sphincter preservation rate;toxicity effects;

Countries

China

Contacts

Public ContactYong Zhang

The First Affiliated Hospital of Guangxi Medical University

zhangyonggxmu@163.com+86 13607884001

Outcome results

None listed

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