Trial Outcomes & Findings for Cisplatin and Docetaxel With or Without Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Newly Diagnosed Stage III Non-Small Cell Lung Cancer (NCT NCT00113386)

NCT ID: NCT00113386

Last Updated: 2013-06-28

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

19 participants

Primary outcome timeframe

Date of death or date of last follow-up

Results posted on

2013-06-28

Participant Flow

Participant milestones

Participant milestones
Measure	Preoperative Cisplatin/Docetaxel Preoperative (induction) cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy; docetaxel 4-6 weeks post-surgery	Preoperative Radiotherapy and Cisplatin/Docetaxel Preoperative (induction) throacic radiation therapy 50.4 Gy concurrently with cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy and radiation therapy; docetaxel 4-6 weeks post-surgery.
Overall Study STARTED	10	9
Overall Study COMPLETED	3	5
Overall Study NOT COMPLETED	7	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Preoperative Cisplatin/Docetaxel Preoperative (induction) cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy; docetaxel 4-6 weeks post-surgery	Preoperative Radiotherapy and Cisplatin/Docetaxel Preoperative (induction) throacic radiation therapy 50.4 Gy concurrently with cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy and radiation therapy; docetaxel 4-6 weeks post-surgery.
Overall Study Withdrawal by Subject	1	0
Overall Study Physician Decision	0	1
Overall Study Toxicity	3	0
Overall Study Ineligible	1	2
Overall Study Unknown - Lost to Follow-Up	2	1

Baseline Characteristics

Cisplatin and Docetaxel With or Without Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Newly Diagnosed Stage III Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Preoperative Cisplatin/Docetaxel n=8 Participants Preoperative cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy; docetaxel 4-6 weeks post-surgery \[Data is reported for eligible patients with on-study information, which is 8 patients.\]	Preoperative Radiotherapy and Cisplatin/Docetaxel n=7 Participants Preoperative throacic radiation therapy 50.4 Gy concurrently with cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy and radiation therapy; docetaxel 4-6 weeks post-surgery. \[Data is reported for eligible patients with on-study information, which is 7 patients.\]	Total n=15 Participants Total of all reporting groups
Age Continuous	66 years n=5 Participants	57 years n=7 Participants	63 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: Date of death or date of last follow-up

Population: This study terminated early with 19 out of 574 subjects accrued. Therefore no analysis was performed.

Outcome measures

Outcome data not reported

Adverse Events

Preoperative Cisplatin/Docetaxel

Serious events: 5 serious events

Other events: 7 other events

Deaths: 0 deaths

Preoperative Radiotherapy and Cisplatin/Docetaxel

Serious events: 4 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Wendy Seiferheld

Radiation Therapy Oncology Group

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Preoperative Cisplatin/Docetaxel n=9 participants at risk Preoperative cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy; docetaxel 4-6 weeks post-surgery. \[Data is reported for eligible patients with adverse event information, which is 9 patients.\]	Preoperative Radiotherapy and Cisplatin/Docetaxel n=7 participants at risk Preoperative throacic radiation therapy 50.4 Gy concurrently with cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy and radiation therapy; docetaxel 4-6 weeks post-surgery. \[Data is reported for eligible patients with adverse event information, which is 7 patients.\]
Blood and lymphatic system disorders Febrile neutropenia	44.4% 4/9 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.
Cardiac disorders Atrial flutter	0.00% 0/9 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.	14.3% 1/7 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.
Cardiac disorders Supraventricular tachycardia	11.1% 1/9 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Colonic hemorrhage	0.00% 0/9 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.	14.3% 1/7 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/9 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.	14.3% 1/7 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.
Infections and infestations Wound infection	11.1% 1/9 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/9 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.	14.3% 1/7 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.
Investigations Neutrophil count decreased	44.4% 4/9 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.	14.3% 1/7 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.
Investigations Platelet count decreased	11.1% 1/9 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.
Investigations White blood cell decreased	33.3% 3/9 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.
Respiratory, thoracic and mediastinal disorders Bronchial fistula	11.1% 1/9 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/9 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.	14.3% 1/7 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.
Respiratory, thoracic and mediastinal disorders Pleural effusion	11.1% 1/9 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.
Respiratory, thoracic and mediastinal disorders Pulmonary fistula	11.1% 1/9 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.
Vascular disorders Hypertension	0.00% 0/9 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.	14.3% 1/7 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.
Vascular disorders Hypotension	11.1% 1/9 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.	14.3% 1/7 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.
Vascular disorders Thromboembolic event	11.1% 1/9 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 If a subject experienced more than one of a given SAE, the subject is counted only once for that SAE. If a subject experienced more than one of a given "Other (Not Includind Serious)" AE, then the subject is counted only once for that "Other (Not Including Serious)" AE.