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Endostatin in Concurrent Chemoradiotherapy of head and neck cancer: A Randomized Controlled Prospective Study

Endostatin in Concurrent Chemoradiotherapy of head and neck cancer: A Randomized Controlled Prospective Study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-08000280
Enrollment
Unknown
Registered
2008-12-30
Start date
2009-01-01
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

Head and neck cancer exclude nasopharyngeal carcinoma

Interventions

Experimental group:Endostatin combined concurrent radiochemotherapy

Sponsors

Sun Yat-Sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18~60 years old; 2.KPS>=70; 3. If the patient has receipted other chemotherapy, he or she can only be treated after 30 days; 4.Clinical staging system is based on AJCC cancer staging manual, 6th Edition, 2002; 5.There is no dysfunction of heart,lung,liver and kidney; 6.Pathological classification of Malignant Epithelial tumor certified by pathological department of Sun Yat-Sen University Cancer Center; 7.Has had head and neck MRI/CT before the treatment; 8. Sign the known agreement of his/her own accord.

Exclusion criteria

Exclusion criteria: 1. Allegic to the drug of research; 2. Tumor can not be evaluated; 3. Distant metastasis; 4. Moderate anemia or more severe; 5. Have purulent or chronic infected wound which exist persistently, and severe infected; 6. Mental disease not under control; 7. Recurrence in 1 year after receipted chemotherapy with platinum; 8. Have had chemotherapy, raidotherapy, biotherapy or other treatment in 30 days; 9. Pregnancy, breast-feeding and non-reproductive; 10. Researchers believe that those who do not fit.

Design outcomes

Primary

MeasureTime frame
Clinical benefit rate, CBR;Response rate, RR;Overall survival of 3 years;Toxicity and its reversability;Overall survival of 5 years;Overall survival, O;

Secondary

MeasureTime frame
Disease free survival, DFS;Quality of life, QOL;Progression-free survival, PFS;Time to progression, TTP;

Countries

China

Contacts

Public ContactJiang Wenqi
huweihan@126.com+86 020 87343352

Outcome results

None listed

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