Trial Outcomes & Findings for Study of Chemotherapy Prior to Radiotherapy and Chemotherapy in Patients With HPV Associated Cancer of the Oral Cavity (NCT NCT01525927)

NCT ID: NCT01525927

Last Updated: 2017-12-19

Results Overview

The 3-month response rate will be estimated using standard methods for estimating proportions and their 95% one-sided confidence intervals (CIs). Comparison to the historical control data will be carried out using a chi-square test for comparing proportions (or a Fisher exact test if an expected cell frequency in the 2x2 table is less than 5). Zero (0) participants analyzed

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: 3 months following completion of radiation phase
• Results posted on: 2017-12-19

Participant Flow

2 participants enrolled, no data collected, no documentation of study intervention.

Participant milestones

Measure	Chemotherapy Responders Patients who respond to chemotherapy are treated with reduced dose radiotherapy. chemotherapy: Chemotherapy for three cycles prior to radiotherapy Reduced dose radiotherapy: Patients who achieve a response to chemotherapy then go on to receive reduced dose radiotherapy.
Overall Study STARTED	0
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Chemotherapy Prior to Radiotherapy and Chemotherapy in Patients With HPV Associated Cancer of the Oral Cavity

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 3 months following completion of radiation phase

Population: No study intervention or data collected.

The 3-month response rate will be estimated using standard methods for estimating proportions and their 95% one-sided confidence intervals (CIs). Comparison to the historical control data will be carried out using a chi-square test for comparing proportions (or a Fisher exact test if an expected cell frequency in the 2x2 table is less than 5).

Zero (0) participants analyzed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Three months following completion of radiation therapy phase.

To define objective tumor response rates to induction chemotherapy and to subsequent radiation-based treatment, per RESIST version 1.1 criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At two years following completion of radiation phase

Population: No study intervention or data collected- Zero (0) participants analyzed

assess Progression-free survival at 2 years.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At two years following completion of radiation phase

Population: No study intervention or data collected- Zero (0) participants analyzed

To assess overall survival at 2 years.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At two years following completion of radiation phase

Population: No study intervention or data collected- Zero (0) participants analyzed

To assess locoregional disease control at 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At two years following completion of radiation phase

Population: No study intervention or data collected- Zero (0) participants analyzed

3.5 To assess distant disease control at 2 years.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, during therapy and up to two years following completion of radiation phase

Population: No study intervention or data collected- Zero (0) participants analyzed

Serial evaluation of functional quality-of-life, including M. D. Anderson Dysphagia Inventory (MDADI) and Oropharyngeal swallowing efficiency (OPSE) measures of swallowing function, as well as formal sialometric measurement of parotid function.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During therapy and up to 5 years following completion of treatment

Population: No study intervention or data collected- Zero (0) participants analyzed

To identify additional toxicity of treatment

Outcome measures

Outcome data not reported

Adverse Events

Chemotherapy Non-responders

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Chemotherapy Responders

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeffrey Revello Sr. Administrative Manager

North Shore LIJ Cancer Institute

Phone: 516 734 7629

Email: jrevello@nshs.edu

Results disclosure agreements

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