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A comparative study between surgery and concurrent radiotherapy and chemotherapy in PR patients with advanced pharyngeal and laryngeal cancer

A comparative study between surgery and concurrent radiotherapy and chemotherapy in PR patients with advanced pharyngeal and laryngeal cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036734
Enrollment
Unknown
Registered
2020-08-25
Start date
2021-01-01
Completion date
Unknown
Last updated
2020-09-21

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

Conditions

advanced pharyngeal and laryngeal cancer

Interventions

concurrent chemotherapy and radiotherapy:concurrent chemotherapy and radiotherapy
Surgery :surgery

Sponsors

The Department of Otolaryngology-Head & Neck Surgery, Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years and = 20mg or a similar dose of corticosteroids (>= 3 months). 9. The function of the main organs is normal, that is, they meet the following criteria: (1) the standard of blood routine examination should meet: (no blood transfusion within 14 days). A. HB >= 90g/L. B. ANC >= 1.5 x 10^9CompL. C. PLT >= 80 x 10^9 shock L. (2) biochemical tests shall meet the following standards: A. BIL 50ml/min (Cockcroft-Gault formula). 10. The subjects voluntarily joined the study, signed the informed consent form, had good compliance and cooperated with the follow-up. 11. Doctors believe that treatment can bring benefits to patients.

Exclusion criteria

Exclusion criteria: 1. Suffer from other malignant tumors within two years or at the same time, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix. 2. People who have been confirmed to be allergic to docetaxel, cisplatin, 5-fluorouracil / or their excipients. 3. A serious and uncontrollable infection. 4. Patients with renal insufficiency, previous renal disease, positive urine protein (urine protein test 2 + or more, or 24-hour urine protein quantity > 1.0g); and other major organ dysfunction. 5. Pregnant or lactating women. 6. Abnormal coagulation function (INR > 1.5, APTT > 1.5 ULN) with bleeding tendency (such as active ulcer lesions in stomach, occult blood in stool (+ +), black stool and / or hematemesis within 3 months, hemoptysis) or lesions close to large blood vessels. 7. Tumor involving skin and / or pharyngeal mucosa with rupture. 8. Patients with a history of psychotropic substance abuse and unable to quit or with mental disorders. 9. Patients who have participated in clinical trials of other drugs within 4 weeks. 10. According to the researchers, there are other serious risks to the safety of patients or patients with concomitant diseases that affect the completion of the study.

Design outcomes

Primary

MeasureTime frame
Disease-free survival rate;Overall survival rate;

Secondary

MeasureTime frame
Progression-free survival;Disease control rate;Throat preservation rate;Quality of life scale score;

Countries

China

Contacts

Public ContactHongliang Zheng

The Department of Otolaryngology-Head & Neck Surgery, Changhai Hospital

zheng_hl2004@163.com+86 13764303602

Outcome results

None listed

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