Trial Outcomes & Findings for Induction Chemotherapy Followed by Chemoradiotherapy for Head and Neck Cancer (NCT NCT01716195)
NCT ID: NCT01716195
Last Updated: 2021-02-26
Results Overview
Defined from date of registration to date of first documentation of progression and/or distant metastasis, or death due to any cause. The true 2-year progression-free survival rate will be estimated by the proportion of efficacy-evaluable patients on study without documentation of disease progression or death 2 years from registration. A 95% confidence interval (CI) for the true progression-free survival rate will be constructed using the Duffy-Santner approach. However, Kaplan-Meier methodology will be used to estimate the final 2-year progression-free survival rate and its 95% CI in case there are censored patients.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2021-02-26
Participant Flow
Participant milestones
| Measure |
Response Adapted Chemoradiation
Paclitaxel 175 mg/m2 + Carboplatin area under curve (AUC) 6 followed by response adapted Radiation Therapy (5 - 6 weeks) + Paclitaxel
Induction Chemotherapy followed by Response Adapted Chemoradiation: All patients receive induction chemotherapy with 2 cycles of paclitaxel and carboplatin followed by response adapted, de-escalated chemoradiation. Patients with a complete or partial response will receive 54 Gy with concurrent paclitaxel and patients with stable disease will receive 60 Gy with concurrent paclitaxel.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One subject withdrew consent during treatment phase
Baseline characteristics by cohort
| Measure |
Response Adapted Chemoradiation
n=18 Participants
Paclitaxel 175 mg/m2 + Carboplatin area under curve (AUC) 6 followed by response adapted Radiation Therapy (5 - 6 weeks) + Paclitaxel
Induction Chemotherapy followed by Response Adapted Chemoradiation: All patients receive induction chemotherapy with 2 cycles of paclitaxel and carboplatin followed by response adapted, de-escalated chemoradiation. Patients with a complete or partial response will receive 54 Gy with concurrent paclitaxel and patients with stable disease will receive 60 Gy with concurrent paclitaxel.
|
|---|---|
|
Age, Continuous
|
63.1 years
n=18 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=17 Participants • One subject withdrew consent during treatment phase
|
|
Sex: Female, Male
Male
|
17 Participants
n=17 Participants • One subject withdrew consent during treatment phase
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=17 Participants • One subject withdrew consent during treatment phase
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=17 Participants • One subject withdrew consent during treatment phase
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=17 Participants • One subject withdrew consent during treatment phase
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=17 Participants • One subject withdrew consent during treatment
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=17 Participants • One subject withdrew consent during treatment
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=17 Participants • One subject withdrew consent during treatment
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=17 Participants • One subject withdrew consent during treatment
|
|
Race (NIH/OMB)
White
|
17 Participants
n=17 Participants • One subject withdrew consent during treatment
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=17 Participants • One subject withdrew consent during treatment
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=17 Participants • One subject withdrew consent during treatment
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: One subject withdrew consent prior to completing study
Defined from date of registration to date of first documentation of progression and/or distant metastasis, or death due to any cause. The true 2-year progression-free survival rate will be estimated by the proportion of efficacy-evaluable patients on study without documentation of disease progression or death 2 years from registration. A 95% confidence interval (CI) for the true progression-free survival rate will be constructed using the Duffy-Santner approach. However, Kaplan-Meier methodology will be used to estimate the final 2-year progression-free survival rate and its 95% CI in case there are censored patients.
Outcome measures
| Measure |
Response Adapted Chemoradiation
n=17 Participants
Paclitaxel 175 mg/m2 + Carboplatin area under curve (AUC) 6 followed by response adapted Radiation Therapy (5 - 6 weeks) + Paclitaxel
Induction Chemotherapy followed by Response Adapted Chemoradiation: All patients receive induction chemotherapy with 2 cycles of paclitaxel and carboplatin followed by response adapted, de-escalated chemoradiation. Patients with a complete or partial response will receive 54 Gy with concurrent paclitaxel and patients with stable disease will receive 60 Gy with concurrent paclitaxel.
|
|---|---|
|
Number of Participants With Progression-free Survival
|
17 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: One subject withdrew consent prior to completing study.
Defined as the time from registration to death using the Kaplan-Meier method..
Outcome measures
| Measure |
Response Adapted Chemoradiation
n=17 Participants
Paclitaxel 175 mg/m2 + Carboplatin area under curve (AUC) 6 followed by response adapted Radiation Therapy (5 - 6 weeks) + Paclitaxel
Induction Chemotherapy followed by Response Adapted Chemoradiation: All patients receive induction chemotherapy with 2 cycles of paclitaxel and carboplatin followed by response adapted, de-escalated chemoradiation. Patients with a complete or partial response will receive 54 Gy with concurrent paclitaxel and patients with stable disease will receive 60 Gy with concurrent paclitaxel.
|
|---|---|
|
Number of Participants With Overall Survival
|
16 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: One subject withdrew consent prior to completing study.
Assessed by NCI Common Toxicity Criteria for Adverse Effects, Version 4.0. Reported participants who experienced an AE during concurrent chemoradiotherapy.
Outcome measures
| Measure |
Response Adapted Chemoradiation
n=17 Participants
Paclitaxel 175 mg/m2 + Carboplatin area under curve (AUC) 6 followed by response adapted Radiation Therapy (5 - 6 weeks) + Paclitaxel
Induction Chemotherapy followed by Response Adapted Chemoradiation: All patients receive induction chemotherapy with 2 cycles of paclitaxel and carboplatin followed by response adapted, de-escalated chemoradiation. Patients with a complete or partial response will receive 54 Gy with concurrent paclitaxel and patients with stable disease will receive 60 Gy with concurrent paclitaxel.
|
|---|---|
|
Number of Patients With Toxicity of Concurrent Chemoradiotherapy
|
17 Participants
|
Adverse Events
Response Adapted Chemoradiation
Serious events: 2 serious events
Other events: 13 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Response Adapted Chemoradiation
n=18 participants at risk
Paclitaxel 175 mg/m2 + Carboplatin area under curve (AUC) 6 followed by response adapted Radiation Therapy (5 - 6 weeks) + Paclitaxel
Induction Chemotherapy followed by Response Adapted Chemoradiation: All patients receive induction chemotherapy with 2 cycles of paclitaxel and carboplatin followed by response adapted, de-escalated chemoradiation. Patients with a complete or partial response will receive 54 Gy with concurrent paclitaxel and patients with stable disease will receive 60 Gy with concurrent paclitaxel.
|
|---|---|
|
Infections and infestations
Skin Infection
|
5.6%
1/18 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
5.6%
1/18 • Number of events 1 • 5 years
|
|
General disorders
Nausea
|
5.6%
1/18 • Number of events 1 • 5 years
|
|
General disorders
Dysphagia
|
5.6%
1/18 • Number of events 1 • 5 years
|
|
General disorders
Sore throat
|
5.6%
1/18 • Number of events 1 • 5 years
|
Other adverse events
| Measure |
Response Adapted Chemoradiation
n=18 participants at risk
Paclitaxel 175 mg/m2 + Carboplatin area under curve (AUC) 6 followed by response adapted Radiation Therapy (5 - 6 weeks) + Paclitaxel
Induction Chemotherapy followed by Response Adapted Chemoradiation: All patients receive induction chemotherapy with 2 cycles of paclitaxel and carboplatin followed by response adapted, de-escalated chemoradiation. Patients with a complete or partial response will receive 54 Gy with concurrent paclitaxel and patients with stable disease will receive 60 Gy with concurrent paclitaxel.
|
|---|---|
|
General disorders
Fatigue
|
55.6%
10/18 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
3/18 • 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
72.2%
13/18 • 5 years
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
33.3%
6/18 • 5 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
11.1%
2/18 • 5 years
|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
16.7%
3/18 • 5 years
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
16.7%
3/18 • 5 years
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
16.7%
3/18 • 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
44.4%
8/18 • 5 years
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
50.0%
9/18 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.1%
2/18 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
6/18 • 5 years
|
|
Ear and labyrinth disorders
Tinnitus
|
16.7%
3/18 • 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
44.4%
8/18 • 5 years
|
|
Gastrointestinal disorders
Dysgeusia
|
27.8%
5/18 • 5 years
|
|
Gastrointestinal disorders
Sore throat
|
27.8%
5/18 • 5 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis radiation
|
38.9%
7/18 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
3/18 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
27.8%
5/18 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
2/18 • 5 years
|
|
Gastrointestinal disorders
Oral Pain
|
27.8%
5/18 • 5 years
|
|
Hepatobiliary disorders
Alkaline phosphatese increased
|
11.1%
2/18 • 5 years
|
|
Immune system disorders
Neutrophil count decreased
|
16.7%
3/18 • 5 years
|
|
Gastrointestinal disorders
Dry Mouth
|
33.3%
6/18 • 5 years
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
16.7%
3/18 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
11.1%
2/18 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
22.2%
4/18 • 5 years
|
|
General disorders
Myalgia
|
11.1%
2/18 • 5 years
|
|
Ear and labyrinth disorders
Ear Pain
|
16.7%
3/18 • 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
22.2%
4/18 • 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
22.2%
4/18 • 5 years
|
|
Psychiatric disorders
Anxiety
|
11.1%
2/18 • 5 years
|
|
Metabolism and nutrition disorders
Weight loss
|
22.2%
4/18 • 5 years
|
|
Cardiac disorders
Sinus bradycardia
|
11.1%
2/18 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
16.7%
3/18 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
11.1%
2/18 • 5 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disorder
|
11.1%
2/18 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place