Trial Outcomes & Findings for Trimodality Management of T1b Esophageal Cancers (NCT NCT01217060)

Last Updated: 2021-04-13

Results Overview

The primary endpoint for this protocol is to assess the efficacy (pathologic complete response) and safety of Trimodality management (chemoradiotherapy followed by esophagectomy) in patients with clinically staged T1bN0M0 cancer of the esophagus or gastroesophageal junction. This is a single-arm phase IIB trial of chemo-radiation followed by surgery for patients with early stage grade T1b esophageal cancer. The rates of pathologic CR will be tabulated and their possible relationships to baseline covariates assessed by logistic regression. Unadjusted progression free survival time will be estimated by the method of Kaplan and Meier and its possible relationship to baseline covariates assessed by survival regression modeling.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Pathologic Complete Response (PCR) will repeat EGD with biopsy to assess for clinical response to therapy after chemoradiation four to six weeks.

Results posted on

2021-04-13

Participant Flow

A total of 4 patients were consented to this study, but 1 patient want to get PROTONS treatment instead of IMRT and withdrew consent. 3 patients was treated under this protocol.

Participant milestones

Participant milestones
Measure	Docetaxel + 5-FU + Radiation + Surgery Docetaxel 20 mg/m2 given by vein (IV) once a week up to 5 1/2 weeks. Dexamethasone 10 mg IV 30 minutes prior to weekly Docetaxel. 5-FU 300 mg/m2 IV, continuously for 96 hours 5 days a week for about 5 1/2 weeks. Radiation 50.4 Gy (1.8G/Fx/day) for about 5 1/2 weeks. Surgery to remove part of esophagus and nearby lymph nodes, approximately 8 to 10 weeks after completing chemoradiation.
Overall Study STARTED	4
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Docetaxel + 5-FU + Radiation + Surgery Docetaxel 20 mg/m2 given by vein (IV) once a week up to 5 1/2 weeks. Dexamethasone 10 mg IV 30 minutes prior to weekly Docetaxel. 5-FU 300 mg/m2 IV, continuously for 96 hours 5 days a week for about 5 1/2 weeks. Radiation 50.4 Gy (1.8G/Fx/day) for about 5 1/2 weeks. Surgery to remove part of esophagus and nearby lymph nodes, approximately 8 to 10 weeks after completing chemoradiation.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Trimodality Management of T1b Esophageal Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Docetaxel + 5-FU + Radiation + Surgery n=3 Participants Docetaxel 20 mg/m2 given by vein (IV) once a week up to 5 1/2 weeks. Dexamethasone 10 mg IV 30 minutes prior to weekly Docetaxel. 5-FU 300 mg/m2 IV, continuously for 96 hours 5 days a week for about 5 1/2 weeks. Radiation 50.4 Gy (1.8G/Fx/day) for about 5 1/2 weeks. Surgery to remove part of esophagus and nearby lymph nodes, approximately 8 to 10 weeks after completing chemoradiation.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	67 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants
Karnofsky performance score (KPS) KPS≥ 80	3 Participants n=5 Participants
Karnofsky performance score (KPS) KPS≥ 70	0 Participants n=5 Participants
Smoking Never	0 Participants n=5 Participants
Smoking Prior	3 Participants n=5 Participants
Smoking Current	0 Participants n=5 Participants
Tumor Location Cardioesophageal Junction (GEJ)	2 Participants n=5 Participants
Tumor Location Lower (distal) esophgus & GEJ	1 Participants n=5 Participants
Tumor Histology- Adenocarcinoma	3 Participants n=5 Participants
Moderate to Poorly Differentiation	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Pathologic Complete Response (PCR) will repeat EGD with biopsy to assess for clinical response to therapy after chemoradiation four to six weeks.

Population: There are no statistical data analysis results available due to the protocol terminated early due to low rate of accrual, changes in treatment paradigm (patients are going for local excision for T1b esophageal cancer). We incorporated the analysis of those patient to the paper of a retrospective cohort, since the 4 patients themselves were not reportable.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time to disease progression or death, up to 6 years

Population: There are no statistical data analysis results available because this protocol termination early due to low rate of accrual, changes in treatment paradigm (patients are going for local excision for T1b esophageal cancer).

Disease-free survival (DFS) defined as the time to disease progression or death. DFS calculated from the time of surgery to disease progression or death. Followed for disease recurrence every 3-6 months in the first 3 years after last dose of radiation and chemotherapy, then every 6 months in the next 2 years, then every year.

Outcome measures

Outcome data not reported

Adverse Events

Docetaxel + 5-FU + Radiation + Surgery

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Docetaxel + 5-FU + Radiation + Surgery n=3 participants at risk Docetaxel 20 mg/m2 given by vein (IV) once a week up to 5 1/2 weeks. Dexamethasone 10 mg IV 30 minutes prior to weekly Docetaxel. 5-FU 300 mg/m2 IV, continuously for 96 hours 5 days a week for about 5 1/2 weeks. Radiation 50.4 Gy (1.8G/Fx/day) for about 5 1/2 weeks. Surgery to remove part of esophagus and nearby lymph nodes, approximately 8 to 10 weeks after completing chemoradiation.
Metabolism and nutrition disorders Anorexia	33.3% 1/3 • Number of events 1 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed at the end of the 30-day period following surgery Toxicity was documented according to the Common Terminology Criteria for Adverse Events (CTCAE) V4.0 during the 10-week period beginning at the start of chemo-radiation and ending at the time of surgery, and post-surgery mortality (PostDeath), defined as death due to any cause during the 30-day period following surgery.
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed at the end of the 30-day period following surgery Toxicity was documented according to the Common Terminology Criteria for Adverse Events (CTCAE) V4.0 during the 10-week period beginning at the start of chemo-radiation and ending at the time of surgery, and post-surgery mortality (PostDeath), defined as death due to any cause during the 30-day period following surgery.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 2 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed at the end of the 30-day period following surgery Toxicity was documented according to the Common Terminology Criteria for Adverse Events (CTCAE) V4.0 during the 10-week period beginning at the start of chemo-radiation and ending at the time of surgery, and post-surgery mortality (PostDeath), defined as death due to any cause during the 30-day period following surgery.
Metabolism and nutrition disorders Diaphoresis	33.3% 1/3 • Number of events 1 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed at the end of the 30-day period following surgery Toxicity was documented according to the Common Terminology Criteria for Adverse Events (CTCAE) V4.0 during the 10-week period beginning at the start of chemo-radiation and ending at the time of surgery, and post-surgery mortality (PostDeath), defined as death due to any cause during the 30-day period following surgery.
Gastrointestinal disorders Diarrhea	66.7% 2/3 • Number of events 2 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed at the end of the 30-day period following surgery Toxicity was documented according to the Common Terminology Criteria for Adverse Events (CTCAE) V4.0 during the 10-week period beginning at the start of chemo-radiation and ending at the time of surgery, and post-surgery mortality (PostDeath), defined as death due to any cause during the 30-day period following surgery.
Nervous system disorders Dysgeusia	33.3% 1/3 • Number of events 1 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed at the end of the 30-day period following surgery Toxicity was documented according to the Common Terminology Criteria for Adverse Events (CTCAE) V4.0 during the 10-week period beginning at the start of chemo-radiation and ending at the time of surgery, and post-surgery mortality (PostDeath), defined as death due to any cause during the 30-day period following surgery.
Gastrointestinal disorders Dyspepsia	66.7% 2/3 • Number of events 2 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed at the end of the 30-day period following surgery Toxicity was documented according to the Common Terminology Criteria for Adverse Events (CTCAE) V4.0 during the 10-week period beginning at the start of chemo-radiation and ending at the time of surgery, and post-surgery mortality (PostDeath), defined as death due to any cause during the 30-day period following surgery.
Gastrointestinal disorders Dysphagia	100.0% 3/3 • Number of events 4 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed at the end of the 30-day period following surgery Toxicity was documented according to the Common Terminology Criteria for Adverse Events (CTCAE) V4.0 during the 10-week period beginning at the start of chemo-radiation and ending at the time of surgery, and post-surgery mortality (PostDeath), defined as death due to any cause during the 30-day period following surgery.
Gastrointestinal disorders Esophagitis	66.7% 2/3 • Number of events 2 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed at the end of the 30-day period following surgery Toxicity was documented according to the Common Terminology Criteria for Adverse Events (CTCAE) V4.0 during the 10-week period beginning at the start of chemo-radiation and ending at the time of surgery, and post-surgery mortality (PostDeath), defined as death due to any cause during the 30-day period following surgery.
General disorders Fatigue	100.0% 3/3 • Number of events 5 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed at the end of the 30-day period following surgery Toxicity was documented according to the Common Terminology Criteria for Adverse Events (CTCAE) V4.0 during the 10-week period beginning at the start of chemo-radiation and ending at the time of surgery, and post-surgery mortality (PostDeath), defined as death due to any cause during the 30-day period following surgery.
Investigations Lymphopenia	33.3% 1/3 • Number of events 1 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed at the end of the 30-day period following surgery Toxicity was documented according to the Common Terminology Criteria for Adverse Events (CTCAE) V4.0 during the 10-week period beginning at the start of chemo-radiation and ending at the time of surgery, and post-surgery mortality (PostDeath), defined as death due to any cause during the 30-day period following surgery.
Respiratory, thoracic and mediastinal disorders Mucositis	33.3% 1/3 • Number of events 1 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed at the end of the 30-day period following surgery Toxicity was documented according to the Common Terminology Criteria for Adverse Events (CTCAE) V4.0 during the 10-week period beginning at the start of chemo-radiation and ending at the time of surgery, and post-surgery mortality (PostDeath), defined as death due to any cause during the 30-day period following surgery.
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed at the end of the 30-day period following surgery Toxicity was documented according to the Common Terminology Criteria for Adverse Events (CTCAE) V4.0 during the 10-week period beginning at the start of chemo-radiation and ending at the time of surgery, and post-surgery mortality (PostDeath), defined as death due to any cause during the 30-day period following surgery.
Nervous system disorders Neuropathy	33.3% 1/3 • Number of events 1 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed at the end of the 30-day period following surgery Toxicity was documented according to the Common Terminology Criteria for Adverse Events (CTCAE) V4.0 during the 10-week period beginning at the start of chemo-radiation and ending at the time of surgery, and post-surgery mortality (PostDeath), defined as death due to any cause during the 30-day period following surgery.
Gastrointestinal disorders Odynophagia	100.0% 3/3 • Number of events 3 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed at the end of the 30-day period following surgery Toxicity was documented according to the Common Terminology Criteria for Adverse Events (CTCAE) V4.0 during the 10-week period beginning at the start of chemo-radiation and ending at the time of surgery, and post-surgery mortality (PostDeath), defined as death due to any cause during the 30-day period following surgery.
Skin and subcutaneous tissue disorders Radiation Dermatitis	33.3% 1/3 • Number of events 2 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed at the end of the 30-day period following surgery Toxicity was documented according to the Common Terminology Criteria for Adverse Events (CTCAE) V4.0 during the 10-week period beginning at the start of chemo-radiation and ending at the time of surgery, and post-surgery mortality (PostDeath), defined as death due to any cause during the 30-day period following surgery.
Skin and subcutaneous tissue disorders Rash (Hand-Foot skin reaction)	33.3% 1/3 • Number of events 2 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed at the end of the 30-day period following surgery Toxicity was documented according to the Common Terminology Criteria for Adverse Events (CTCAE) V4.0 during the 10-week period beginning at the start of chemo-radiation and ending at the time of surgery, and post-surgery mortality (PostDeath), defined as death due to any cause during the 30-day period following surgery.
Respiratory, thoracic and mediastinal disorders Sore throat	33.3% 1/3 • Number of events 1 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed at the end of the 30-day period following surgery Toxicity was documented according to the Common Terminology Criteria for Adverse Events (CTCAE) V4.0 during the 10-week period beginning at the start of chemo-radiation and ending at the time of surgery, and post-surgery mortality (PostDeath), defined as death due to any cause during the 30-day period following surgery.
Investigations Weight loss	33.3% 1/3 • Number of events 1 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed at the end of the 30-day period following surgery Toxicity was documented according to the Common Terminology Criteria for Adverse Events (CTCAE) V4.0 during the 10-week period beginning at the start of chemo-radiation and ending at the time of surgery, and post-surgery mortality (PostDeath), defined as death due to any cause during the 30-day period following surgery.

Additional Information

Steven H. Lin, Associate Professor, Radiation Oncology Department

UT MD Anderson Cancer Center

Phone: (713) 563-8490

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place