GDF15-based chemotherapy for advanced oral cancer
GDF15 (Growth Differentiation Factor 15) Based TPF Induction Chemotherapy for Oral Squamous Cell Carcinoma Patients at T3/T4cN0M0 Stage: a Phase II Randomized Controlled Trial
This study is testing if a specific chemotherapy treatment can help people with advanced oral cancer who have high levels of a protein called GDF15 feel better and have better outcomes compared to those who only get surgery and radiation.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT02285530 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of TPF induction chemotherapy in patients with advanced oral squamous cell carcinoma (OSCC) who have high levels of GDF15 expression. The study involves a randomized control design where participants will receive either TPF chemotherapy followed by surgery and radiotherapy or undergo surgery and radiotherapy alone. The goal is to determine if GDF15 can serve as a predictive biomarker for improved treatment outcomes in this patient population. The trial is designed to provide insights into the potential benefits of induction chemotherapy for those with resectable tumors.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with resectable T3/T4cN0M0 oral squamous cell carcinoma and high GDF15 expression.
Not a fit: Patients with distant metastatic disease or those who have undergone prior treatments such as chemotherapy or radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes for patients with advanced oral squamous cell carcinoma.
How similar studies have performed: Previous studies have suggested that GDF15 may be a predictive biomarker for chemotherapy response, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 18 to 75 years old. * Sex: both males and females. * Karnofsky performance status (KPS) \>60. * Histological biopsy confirming squamous cell carcinoma of the oral cavity (tongue, gingiva, buccal mucosa, floor of mouth, palate, and retromolar region). * GDF1 high expression * Clinical stage III/IVA (T1-2, N2, M0 or T3-4, N2, M0, UICC\[international Union Against Cancer \] 2002) with resectable lesions. * Adequate hematologic function: white blood cell \>3,000/mm3, hemoglobin\>8g/L, platelet count\>80,000/mm3. * Hepatic function: ALAT(alanine aminotransferase)/ASAT(aspartate transaminase) \<2.5 times the upper limit of normal (ULN), bilirubin \<1.5 times ULN. * Renal function: serum creatinine \<1.5 times ULN. * Written informed consent Exclusion Criteria: * Evidence of distant metastatic disease and other cancers. * Surgical procedure of the primary tumors or lymph nodes (except diagnostic biopsy). * Previous radiotherapy or chemotherapy. * Other previous malignancies within 5 years. * Can not tolerate the treatment protocol with systematic diseases such as history of severe pulmonary or cardiac diseases. * Legal incapacity or limited legal capacity. * Creatinine clearance \<30ml/min. * Pregnancy (confirmed by serum or urine β-HCG) or lactation period.
Where this trial is running
Shanghai, Shanghai
- Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, Shanghai, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.