Trial Outcomes & Findings for Cetuximab and Combination Chemotherapy in Patients With Stage III-IV Resectable Oropharynx Cancer (NCT NCT00665392)

NCT ID: NCT00665392

Last Updated: 2025-08-01

Results Overview

The evaluation of tumor response rate was assessed by computed tomography scan of the neck and chest at Baseline, then at 3 months from inclusion using RECIST1.0 criteria and clinical examination

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 42 participants
• Primary outcome timeframe: at 3 months after ETPF combination
• Results posted on: 2025-08-01

Participant Flow

From July 2008 to April 2013, 42 patients were enrolled. This study was conducted in France, in 9 active centers: Hospital Tenon, HEGP, Hospital Bichat, GH St Joseph Paris, Hospital Foch Suresnes, CH Lyon Sud, Hospital Delafontaine St Denis, Centre René Huguenin St Cloud et Hospital Simone Veil Montmorency.

The main inclusion criteria: Previously untreated, resectable stage III (T3 or T1 - 2N1 - 2M0) to IVB (T4 or T1 -3N3M0) SCCHN of the oropharynx, measurable or evaluable disease, WHO performance status ≤ 1, adequate hematologic, renal and liver functions. The main exclusion criteria: uncontrolled cardiac or other disease, hearing impairment

Participant milestones

Measure	ETPF Adminstration cisplatin: 75 mg/m², day 1. 3 cycles docetaxel: 75 mg/m² Day 1. 3 cycles fluorouracil: 750 mg/m² day 1 to day 5. 3 cycles Cetuximab: 400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles.
Overall Study STARTED	42
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	ETPF Adminstration cisplatin: 75 mg/m², day 1. 3 cycles docetaxel: 75 mg/m² Day 1. 3 cycles fluorouracil: 750 mg/m² day 1 to day 5. 3 cycles Cetuximab: 400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles.
Overall Study not treated	1

Baseline Characteristics

Cetuximab and Combination Chemotherapy in Patients With Stage III-IV Resectable Oropharynx Cancer

Baseline characteristics by cohort

Measure	Cetuximab n=42 Participants cisplatin: 75 mg/m², day 1. 3 cycles docetaxel: 75 mg/m² Day 1. 3 cycles fluorouracil: 750 mg/m² day 1 to day 5. 3 cycles Cetuximab: 400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles.
Age, Continuous	56.1 years STANDARD_DEVIATION 6.8 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants
Region of Enrollment France	42 participants n=5 Participants
Grade of differentiation Well	17 participants n=5 Participants
Grade of differentiation Moderate	18 participants n=5 Participants
Grade of differentiation Poor or undifferentiated	4 participants n=5 Participants
Grade of differentiation Missing	3 participants n=5 Participants
Primary tumor localization Anterior	3 participants n=5 Participants
Primary tumor localization Lateral (tonsillar area)	37 participants n=5 Participants
Primary tumor localization Posterior	1 participants n=5 Participants
Primary tumor localization Superior	1 participants n=5 Participants
T-stage T2	13 participants n=5 Participants
T-stage T3	24 participants n=5 Participants
T-stage T4	5 participants n=5 Participants
N-stage N0	5 participants n=5 Participants
N-stage N1	9 participants n=5 Participants
N-stage N2	27 participants n=5 Participants
N-stage N3	1 participants n=5 Participants
Cancer Staging at the inclusion III	32 participants n=5 Participants
Cancer Staging at the inclusion IV	10 participants n=5 Participants
Lip mobility Normal	40 participants n=5 Participants
Lip mobility Decreased	2 participants n=5 Participants
Trismus Yes	5 participants n=5 Participants
Trismus No	37 participants n=5 Participants
Creatinine clearance (mL/min) < 60	1 participants n=5 Participants
Creatinine clearance (mL/min) 60 -120	31 participants n=5 Participants
Creatinine clearance (mL/min) > 120	8 participants n=5 Participants
Creatinine clearance (mL/min) Missing	2 participants n=5 Participants
Albuminemia (g/L) < 40	8 participants n=5 Participants
Albuminemia (g/L) ≥ 60	14 participants n=5 Participants
Albuminemia (g/L) Missing	20 participants n=5 Participants
Life style risk factors Alcohol	3 participants n=5 Participants
Life style risk factors Tobacco	8 participants n=5 Participants
Life style risk factors Alcohol + Tobacco	25 participants n=5 Participants
Life style risk factors None	6 participants n=5 Participants
HPV 16 status Positive	17 participants n=5 Participants
HPV 16 status Negative	25 participants n=5 Participants
ECOG performance status ECOG - PS=0	33 participants n=5 Participants
ECOG performance status ECOG - PS=1	8 participants n=5 Participants
ECOG performance status Missing	1 participants n=5 Participants

PRIMARY outcome

Timeframe: at 3 months after ETPF combination

The evaluation of tumor response rate was assessed by computed tomography scan of the neck and chest at Baseline, then at 3 months from inclusion using RECIST1.0 criteria and clinical examination

Outcome measures

Measure	ETPF Administration n=41 Participants cisplatin: 75 mg/m², day 1. 3 cycles docetaxel: 75 mg/m² Day 1. 3 cycles fluorouracil: 750 mg/m² day 1 to day 5. 3 cycles Cetuximab: 400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles.
Clinical and Radiological Complete Clinical Response (crCR) Rate at 3 Months Tumor response Rate - Tumor	9 participants
Clinical and Radiological Complete Clinical Response (crCR) Rate at 3 Months Tumor response rate - node	8 participants
Clinical and Radiological Complete Clinical Response (crCR) Rate at 3 Months Tumor response rate - Tumor and node	4 participants

SECONDARY outcome

Timeframe: at 3 months

Clinical complete response (cCR) is defined by:

• Disappearance of all clinical evidence of visible tumor,
• Disappearance of all palpable residual infiltration,
• Disappearance of all evidence of residual visible tumor on CT scan in pharynx and parapharyngeal space,
• Complete symmetric remobilization of the tongue and amygdala.
• Disappearance of pre-existing trismus.
• Negative control biopsy.

The evaluation of tumor response rate was assessed by computed tomography scan of the neck and chest at Baseline, then at 3 months from inclusion using RECIST1.0 criteria and clinical examination

Outcome measures

Measure	ETPF Administration n=41 Participants cisplatin: 75 mg/m², day 1. 3 cycles docetaxel: 75 mg/m² Day 1. 3 cycles fluorouracil: 750 mg/m² day 1 to day 5. 3 cycles Cetuximab: 400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles.
Complete Clinical Response (cCR) Tumor response rate - tumor	17 participants
Complete Clinical Response (cCR) Tumor response rate - node	15 participants
Complete Clinical Response (cCR) Tumor response rate - Tumor and node	13 participants

SECONDARY outcome

Timeframe: 2 years

Population: Median OS was not achieved. The 2-year estimated rate is given.

2-year OS measured survival at 2 years from randomization.

Outcome measures

Measure	ETPF Administration n=41 Participants cisplatin: 75 mg/m², day 1. 3 cycles docetaxel: 75 mg/m² Day 1. 3 cycles fluorouracil: 750 mg/m² day 1 to day 5. 3 cycles Cetuximab: 400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles.
The 2-year Estimated Overall Survival (OS) Rate	82 percentage of participants

SECONDARY outcome

Timeframe: after surgery of the primary tumor

Population: Pathological response is evaluable in patients with tumor surgical resection only

On primary tumor resected : measure of persistence or not of tumoral lesion, histological type, size and quality of the excision piece

A pathological complete response is defined as no viable tumour cells detected on histological examination post surgery.

Outcome measures

Measure	ETPF Administration n=22 Participants cisplatin: 75 mg/m², day 1. 3 cycles docetaxel: 75 mg/m² Day 1. 3 cycles fluorouracil: 750 mg/m² day 1 to day 5. 3 cycles Cetuximab: 400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles.
Pathologic Response	9 participants

SECONDARY outcome

Timeframe: 2 years

2-year PFS measured survival at 2 years from randomization.

Outcome measures

Measure	ETPF Administration n=41 Participants cisplatin: 75 mg/m², day 1. 3 cycles docetaxel: 75 mg/m² Day 1. 3 cycles fluorouracil: 750 mg/m² day 1 to day 5. 3 cycles Cetuximab: 400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles.
The 2-year Estimated Progression-free Survival (PFS)	64 percentage of participants

SECONDARY outcome

Timeframe: At 3 months after the end of 3 cycles of the ETPF combination

Population: Patients in the mITT population who received ETPF

Radiological response is defined according to RECIST 1.0 criteria:

• Complete response (CR): disappearance of all target lesions
• Partial response (PR): at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter,
• Progressive disease (PD): at least a 20% increase in the sum of the longest diameter of target the appearance of one or more new lesions,
• Stable disease (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started

Outcome measures

Measure	ETPF Administration n=41 Participants cisplatin: 75 mg/m², day 1. 3 cycles docetaxel: 75 mg/m² Day 1. 3 cycles fluorouracil: 750 mg/m² day 1 to day 5. 3 cycles Cetuximab: 400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles.
Complete Radiological Response (rCR) Tumor response rate - Tumor	14 participants
Complete Radiological Response (rCR) Tumor response rate - Node	8 participants
Complete Radiological Response (rCR) Tumor response rate - Tumor and node	4 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: correlative studies investigating HPV status in tumor and blood samples obtained prior to and after induction therapy were done for exploratory purposes as planned in the protocol

Outcome measures

Measure	ETPF Administration n=42 Participants cisplatin: 75 mg/m², day 1. 3 cycles docetaxel: 75 mg/m² Day 1. 3 cycles fluorouracil: 750 mg/m² day 1 to day 5. 3 cycles Cetuximab: 400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles.
Biomarkers Analysis - HPV Genotyping HPV16 - Positive	17 participants
Biomarkers Analysis - HPV Genotyping HPV16 - Negative	25 participants

Adverse Events

ETPF Administration

Serious events: 13 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Measure	ETPF Administration n=41 participants at risk cisplatin: 75 mg/m², day 1. 3 cycles docetaxel: 75 mg/m² Day 1. 3 cycles fluorouracil: 750 mg/m² day 1 to day 5. 3 cycles Cetuximab: 400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles.
Vascular disorders Hypovolaemia	2.4% 1/41 • Until 1 month after the last administration Adverse events (AE) were collected during induction treatment and follow-up visit (1 month).Toxicity evaluation was carried out according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v3.0)
Cardiac disorders Orthostatic hypotension	2.4% 1/41 • Until 1 month after the last administration Adverse events (AE) were collected during induction treatment and follow-up visit (1 month).Toxicity evaluation was carried out according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v3.0)
Cardiac disorders Cardiac arrest	2.4% 1/41 • Number of events 1 • Until 1 month after the last administration Adverse events (AE) were collected during induction treatment and follow-up visit (1 month).Toxicity evaluation was carried out according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v3.0)
Gastrointestinal disorders Vomiting	4.9% 2/41 • Until 1 month after the last administration Adverse events (AE) were collected during induction treatment and follow-up visit (1 month).Toxicity evaluation was carried out according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v3.0)
Gastrointestinal disorders Diarrhoea	7.3% 3/41 • Until 1 month after the last administration Adverse events (AE) were collected during induction treatment and follow-up visit (1 month).Toxicity evaluation was carried out according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v3.0)
Hepatobiliary disorders Acute pancreatitis	2.4% 1/41 • Until 1 month after the last administration Adverse events (AE) were collected during induction treatment and follow-up visit (1 month).Toxicity evaluation was carried out according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v3.0)
Renal and urinary disorders Renal failure	2.4% 1/41 • Until 1 month after the last administration Adverse events (AE) were collected during induction treatment and follow-up visit (1 month).Toxicity evaluation was carried out according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v3.0)
Infections and infestations Febrile aplasia	4.9% 2/41 • Until 1 month after the last administration Adverse events (AE) were collected during induction treatment and follow-up visit (1 month).Toxicity evaluation was carried out according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v3.0)
Infections and infestations sepsis	2.4% 1/41 • Until 1 month after the last administration Adverse events (AE) were collected during induction treatment and follow-up visit (1 month).Toxicity evaluation was carried out according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v3.0)
Infections and infestations Febrile neutropenia	2.4% 1/41 • Until 1 month after the last administration Adverse events (AE) were collected during induction treatment and follow-up visit (1 month).Toxicity evaluation was carried out according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v3.0)
Infections and infestations Infection at the portacath site	4.9% 2/41 • Until 1 month after the last administration Adverse events (AE) were collected during induction treatment and follow-up visit (1 month).Toxicity evaluation was carried out according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v3.0)

Other adverse events

Measure	ETPF Administration n=41 participants at risk cisplatin: 75 mg/m², day 1. 3 cycles docetaxel: 75 mg/m² Day 1. 3 cycles fluorouracil: 750 mg/m² day 1 to day 5. 3 cycles Cetuximab: 400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles.
Blood and lymphatic system disorders Neutropenia	43.9% 18/41 • Until 1 month after the last administration Adverse events (AE) were collected during induction treatment and follow-up visit (1 month).Toxicity evaluation was carried out according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v3.0)
Blood and lymphatic system disorders Anemia	80.5% 33/41 • Until 1 month after the last administration Adverse events (AE) were collected during induction treatment and follow-up visit (1 month).Toxicity evaluation was carried out according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v3.0)
Blood and lymphatic system disorders Thrombocytopenia	22.0% 9/41 • Until 1 month after the last administration Adverse events (AE) were collected during induction treatment and follow-up visit (1 month).Toxicity evaluation was carried out according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v3.0)
Blood and lymphatic system disorders Creatinine	22.0% 9/41 • Until 1 month after the last administration Adverse events (AE) were collected during induction treatment and follow-up visit (1 month).Toxicity evaluation was carried out according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v3.0)
Nervous system disorders Neuropathy peripheral	9.8% 4/41 • Until 1 month after the last administration Adverse events (AE) were collected during induction treatment and follow-up visit (1 month).Toxicity evaluation was carried out according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v3.0)
Gastrointestinal disorders Nausea	39.0% 16/41 • Until 1 month after the last administration Adverse events (AE) were collected during induction treatment and follow-up visit (1 month).Toxicity evaluation was carried out according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v3.0)
Gastrointestinal disorders Vomiting	31.7% 13/41 • Until 1 month after the last administration Adverse events (AE) were collected during induction treatment and follow-up visit (1 month).Toxicity evaluation was carried out according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v3.0)
Gastrointestinal disorders Stomatitis	34.1% 14/41 • Until 1 month after the last administration Adverse events (AE) were collected during induction treatment and follow-up visit (1 month).Toxicity evaluation was carried out according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v3.0)
Gastrointestinal disorders Diarrhoea	65.9% 27/41 • Until 1 month after the last administration Adverse events (AE) were collected during induction treatment and follow-up visit (1 month).Toxicity evaluation was carried out according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v3.0)
Skin and subcutaneous tissue disorders Acne	43.9% 18/41 • Until 1 month after the last administration Adverse events (AE) were collected during induction treatment and follow-up visit (1 month).Toxicity evaluation was carried out according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v3.0)
Infections and infestations Febrile neutropenia	19.5% 8/41 • Until 1 month after the last administration Adverse events (AE) were collected during induction treatment and follow-up visit (1 month).Toxicity evaluation was carried out according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v3.0)

Additional Information

Regulatory Affairs

GERCOR

Phone: +33 (0)1 40 29 85 00

Email: regulatory.affairs@gercor.com.fr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place