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A phase III randomized controlled study of adjuvant chemoradiotherapy plus or without anrotenib after primary treatment of locally advanced tongue cancer

A phase III randomized controlled study of adjuvant chemoradiotherapy plus or without anrotenib after primary treatment of locally advanced tongue cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029673
Enrollment
Unknown
Registered
2020-02-09
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-02-10

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

Conditions

Advanced tongue cancer

Interventions

experimental group:Postoperative concurrent chemoradiotherapy combined with Rotinil
control group:11/5000 Postoperative adjuvant concurrent chemoradiotherapy alone

Sponsors

Tumor Hospital Affiliated Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with locally advanced tongue cancer (PT3 -- 4N1/N2 -- 3M0) were confirmed by postoperative pathological tissue after initial treatment (according to AJCC port, Lumen carcinoma 8th edition staging, 2017), pathological types include squamous cell carcinoma and adenocarcinoma; 2. Imaging and clinical physical examination excluded distant organ metastasis; 3. Male or non-pregnant or lactating female; 4. The ECOG score was 0-2 for the body status score; 5. Aged from 18 to 75 years; 6. Hematological examination: Leucocyte count or 4 x 10^9 / L; Neutrophil count acuity 1.5 x 10^9 / L; Platelet count 100 x 10^9 / L or higher; Hemoglobin or 9 g/L 7. Blood biochemical examination: Total bilirubin, AST, ALT acuities were 2.0 times the upper limit of normal value; Creatinine 1.5 times the upper limit of normal or less; 8. Informed consent has been signed.

Exclusion criteria

Exclusion criteria: 1. Other pathological types of tongue carcinoma other than squamous and adenocarcinoma; 2. Ppatients with recurrence or distant metastasis; 3. Have had or are suffering from other tumors whose primary site or histology is different from the tumor evaluated in this study. Carcinoma in situ of the cervix, cured basal cell carcinoma and bladder surface tumor were excluded [Ta, Tis&T1]; 4. The patient suffers from other uncontrolled serious diseases; 5. Non-compliance or the researcher believes that the patient cannot complete the whole trial treatment; 6. Abnormal function of heart, brain, lung and other important organs; 7. Pregnant or lactating patients; 8. No MRI was performed within 3 months after the end of radiotherapy, or MRI examination could not be performed for other reasons.

Design outcomes

Primary

MeasureTime frame
progress free survival;

Secondary

MeasureTime frame
overall survival;locoregional failure-free survival;distant failure-free survival;therapeutic toxicity and compliance;

Countries

China

Contacts

Public ContactGuan Ying

Tumor Hospital Affiliated Guangxi Medical University

386927552@qq.com+86 14795637030

Outcome results

None listed

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