Trial Outcomes & Findings for Trial of Neoadjuvant Therapy With Paclitaxel and Carboplatin in Operable Locally Advanced Head and Neck Cancer Patients (NCT NCT05294900)
NCT ID: NCT05294900
Last Updated: 2026-05-26
Results Overview
Major Pathologic Response (MPR) was defined as ≤10% residual viable tumor cells in the resected primary tumor specimen following completion of two cycles of neoadjuvant paclitaxel-carboplatin chemotherapy. Pathologic evaluation was performed by two independent board-certified pathologists in a blinded manner. MPR reflects the extent of tumor regression induced by neoadjuvant therapy and serves as a key indicator of treatment efficacy in resectable head and neck squamous cell carcinoma.
COMPLETED
PHASE2
79 participants
At the time of surgery following two cycles of neoadjuvant paclitaxel-carboplatin chemotherapy (approximately 6-9 weeks after treatment initiation).
2026-05-26
Participant Flow
Participants were recruited at two academic medical centers in the Republic of Korea. Eligible patients with resectable, locally advanced head and neck squamous cell carcinoma were enrolled consecutively between May 2023 and March 2024.
A total of 83 patients were screened for eligibility. Four patients did not meet the eligibility criteria and were not assigned to the study treatment. Seventy-nine patients were enrolled and proceeded to receive neoadjuvant chemotherapy. No patients were excluded for safety reasons before assignment.
Participant milestones
| Measure |
Paclitaxel/Carboplatin
Participants receive neoadjuvant chemotherapy with paclitaxel (175 mg/m²) and carboplatin (AUC 5), administered intravenously every 3 weeks for two cycles. Pegylated G-CSF may be administered at the investigator's discretion following chemotherapy. After completion of neoadjuvant therapy, participants undergo curative-intent surgical resection within 2 to 9 weeks. Postoperative adjuvant treatment, including chemoradiotherapy, may be provided based on high-risk pathological features but is not part of the investigational intervention.
|
|---|---|
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Neoadjuvant Chemotherapy
STARTED
|
79
|
|
Neoadjuvant Chemotherapy
COMPLETED
|
76
|
|
Neoadjuvant Chemotherapy
NOT COMPLETED
|
3
|
|
Surgery Milestone
STARTED
|
76
|
|
Surgery Milestone
COMPLETED
|
72
|
|
Surgery Milestone
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
All enrolled participants were included in this baseline analysis
Baseline characteristics by cohort
| Measure |
Paclitaxel/Carboplatin
n=79 Participants
Participants receive neoadjuvant chemotherapy with paclitaxel (175 mg/m²) and carboplatin (AUC 5), administered intravenously every 3 weeks for two cycles. Pegylated G-CSF may be administered at the investigator's discretion following chemotherapy. After completion of neoadjuvant therapy, participants undergo curative-intent surgical resection within 2 to 9 weeks. Postoperative adjuvant treatment, including chemoradiotherapy, may be provided based on high-risk pathological features but is not part of the investigational intervention.
|
|---|---|
|
Age, Continuous
|
62 years
n=79 Participants • All enrolled participants were included in this baseline analysis
|
|
Sex: Female, Male
Female
|
12 Participants
n=79 Participants • No difference
|
|
Sex: Female, Male
Male
|
67 Participants
n=79 Participants • No difference
|
|
Region of Enrollment
South Korea
|
79 Participants
n=79 Participants • All enrolled participants were included in the region of enrollment analysis.
|
|
Baseline disease characteristics
|
79 Participants
n=79 Participants
|
PRIMARY outcome
Timeframe: At the time of surgery following two cycles of neoadjuvant paclitaxel-carboplatin chemotherapy (approximately 6-9 weeks after treatment initiation).Major Pathologic Response (MPR) was defined as ≤10% residual viable tumor cells in the resected primary tumor specimen following completion of two cycles of neoadjuvant paclitaxel-carboplatin chemotherapy. Pathologic evaluation was performed by two independent board-certified pathologists in a blinded manner. MPR reflects the extent of tumor regression induced by neoadjuvant therapy and serves as a key indicator of treatment efficacy in resectable head and neck squamous cell carcinoma.
Outcome measures
| Measure |
Paclitaxel/Carboplatin
n=72 Participants
Participants receive neoadjuvant chemotherapy consisting of paclitaxel (175 mg/m²) and carboplatin (AUC 5), administered intravenously every 3 weeks for two cycles. Pegylated G-CSF may be administered at the investigator's discretion. Following completion of neoadjuvant therapy, participants undergo curative-intent surgical resection between 2 and 9 weeks. Postoperative adjuvant therapy, including chemoradiotherapy, may be given based on high-risk pathological features, but is not part of the investigational intervention.
|
|---|---|
|
Major Pathologic Response
|
22 Participants
|
Adverse Events
Paclitaxel/Carboplatin
Serious adverse events
| Measure |
Paclitaxel/Carboplatin
n=79 participants at risk
Participants receive neoadjuvant chemotherapy with paclitaxel (175 mg/m²) and carboplatin (AUC 5), administered intravenously every 3 weeks for two cycles. Pegylated G-CSF may be administered at the investigator's discretion following chemotherapy. After completion of neoadjuvant therapy, participants undergo curative-intent surgical resection within 2 to 9 weeks. Postoperative adjuvant treatment, including chemoradiotherapy, may be provided based on high-risk pathological features but is not part of the investigational intervention.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.3%
1/79 • From initiation of neoadjuvant chemotherapy through 30 days after surgery.
Adverse events were assessed systematically at each treatment cycle and during the postoperative period. Definitions follow CTCAE v5.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer bleeding
|
1.3%
1/79 • From initiation of neoadjuvant chemotherapy through 30 days after surgery.
Adverse events were assessed systematically at each treatment cycle and during the postoperative period. Definitions follow CTCAE v5.0.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.3%
1/79 • From initiation of neoadjuvant chemotherapy through 30 days after surgery.
Adverse events were assessed systematically at each treatment cycle and during the postoperative period. Definitions follow CTCAE v5.0.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place