Effectiveness of incorporating cetuximab into both docetaxel/cisplatin/fluorouracil induction chemotherapy and chemoradiotherapy in inoperable squamous cell carcinoma of the oral cavity

C-TPF (cetuximab, cisplatin, docetaxel, 5-FU) induction chemotherapy in inoperable squamous cell carcinoma of oral cavity: a phase II study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13782908

Enrollment

Registered

2015-10-26

Start date

2015-09-30

Completion date

Unknown

Last updated

2021-05-24

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

Conditions

Oral Squamous Cell Carcinoma Cancer Oral Squamous Cell Carcinoma

Interventions

All participants receive two cycles of C-TPF induction treatment. After completing the induction, MRI will be examined for the response of the treatment. Only complete or partial response participants

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged between 18-70 years 2. Histologically proven locally advanced inoperable stage IV oral squamous cell carcinoma (OSCC) 3. At least one measurable lesion 4. An ECOG performance status 3 x 109/L, neutrophils > 1.5 x109/L, hemoglobin > 9 g/dl, platelets > 100 x 109/L) 6. Adequate liver and renal function panel (serum bilirubin 50 ml/min) 7. Life expectancy of more than 12 weeks 8. Effective contraception for both male and female subjects if the risk of conception exists

Exclusion criteria

Exclusion criteria: 1. Distant metastasis or locally recurrent tumors 2. Prior chemotherapy, radiotherapy or surgery for HNC 3. Simultaneous double cancers except for cervical carcinoma in situ 4. Localized skin squamous cell cancer, or basal cell carcinoma of the skin 5. Use of an investigational agent within the past 28 days prior to enrollment 6. Known grade 3/4 allergic reactions to any components of the treatment 7. Pregnancy or breast-feeding 8. Clinically active disease unrelated to cancer itself 9. History of severe pulmonary or cardiac disease in the past 12 months 10. Uncontrolled chronic neuropathy 11. Participation in another clinical trial within the past 30 days 12. Legal incapacity or limited legal capacity

Design outcomes

Primary

Measure	Time frame
Objective response rate (ORR) of induction chemotherapy is measured by MRI according to RECIST criteria in week 7, after two cycles of C-TPF treatment.	—

Secondary

Measure	Time frame
1. Progression free survival will be measured by MRI first 2 months after bio-CRT and then every 3 months, until disease progression or patient death 2. Overall survival will be followed up until patient death at physicians' clinic visits every month 3. Efficacy of bio-CRT will be measure by comparing the first MRI 2 months after bio-CRT to the MRI taken after induction chemotherapy 4. Acute side effects are recorded during the treatment of induction and bio-CRT. Late side effects are recorded by physicians during the follow-up clinic visits.	—

Measure

Time frame

1. Progression free survival will be measured by MRI first 2 months after bio-CRT and then every 3 months, until disease progression or patient death 2. Overall survival will be followed up until patient death at physicians' clinic visits every month 3. Efficacy of bio-CRT will be measure by comparing the first MRI 2 months after bio-CRT to the MRI taken after induction chemotherapy 4. Acute side effects are recorded during the treatment of induction and bio-CRT. Late side effects are recorded by physicians during the follow-up clinic visits.

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Countries

Taiwan

Contacts

Public ContactMuh Hwa Yang

Outcome results

None listed

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