Clinical trial · Interventional
Docetaxel and Loplatin Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced SCCHN
A Prospective Phase II Randomized Clinical Trial: Docetaxel and Loplatin Induction Chemotherapy Followed by Concurrent Lobaplatin Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to observe and compare the safety and tolerability of docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy and TPF induction chemotherapy combined with cisplatin chemoradiotherapy in the treatment of locally advanced head and neck squamous cell carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Lobaplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- the treatment group
- description
- docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy
- interventionNames
- Drug: Lobaplatin
- type
- ACTIVE_COMPARATOR
- label
- the control group
- description
- TPF induction chemotherapy combined with cisplatin chemoradiotherapy
- interventionNames
- Drug: Cisplatin
Primary outcomes (2)
- measure
- National Cancer Institute CTCAE v4.0
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Voluntary participation and written informed consent 2. Age 18-70 years old, gender is not limited 3. histologically proved to be squamous cell carcinoma 4. No surgery: head and neck squamous cell carcinoma 2010UICC staging Ⅲ - ⅣA, ⅣB period. After surgery: 2010UICC staging ⅣA, ⅣB;stage III tongue base or hypopharyngeal primaries;Postoperative naked eye or image residual stage III patients 5. Karnofsky score ≥70 6. Survival is expected to be ≥ 6 months 7. Women of childbearing age should be guaranteed contraception during the study period 8. (WBC) ≥4 × 109 / L \* (unit normal), platelet (PLT) ≥100 × 109 / L (unit normal value), neutrophil cell (WBC), hematocrit (WBC) ≥1.5 × 109 / L \* (unit normal value) 9. liver function: alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT) \<upper limit of normal (ULN) 1.5 times; total bilirubin \<1.5 × ULN 10. renal function: serum creatinine \<1.5 × ULN, endogenous creatinine clearance rate (Ccr) ≥ 55 ml / min 11. no serious complications such as hypertension, diabetes, coronary heart disease and psychiatric history 12. The treatment for the first course of treatment (no head and neck radiotherapy, no chemotherapy within 3 months). Exclusion Criteria: 1. There is a distant shift 2. primary lesions or lymph nodes were radiotherapy 3. had received epidermal growth factor targeted therapy 4. primary tumor had received chemotherapy or immunotherapy 5. had other malignancies (except for cured basal cell carcinoma or cervical cancer) 6. pregnant women or lactating women and treatment during the observation period of contraceptive women of childbearing age 7. have a serious history of allergies or specific physical 8. Abuse of drugs or alcohol addicts 9. Person who has personality or mental illness, no civil capacity or limited civil capacity
References
Publications (1)
- DERIVEDZhang M, Chen Y, Wu W, Jin F, Li Y, Long J, Luo X, Gong X, Chen X, Liu L, Tang H, Wang Z. A prospective phase II randomized study of docetaxel combined with lobaplatin versus TPF regimen induction chemotherapy followed by concurrent chemoradiotherapy for locally advanced head and neck squamous cell carcinoma. J Cancer Res Clin Oncol. 2023 Dec;149(20):18081-18091. doi: 10.1007/s00432-023-05497-1. Epub 2023 Nov 20. PMID 37985501