Trial Outcomes & Findings for Study With Intensity Modulated Radiation Therapy With Cisplatin to Treat Stage I-IVA Cervical Cancer (NCT NCT01554397)

NCT ID: NCT01554397

Last Updated: 2024-11-29

Results Overview

Acute grade \>= 3 neutropenia or clinically significant \>=2 diarrhea or any grade \>=3 GI toxicity

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 101 participants
• Primary outcome timeframe: Up to 30 days post radiation, about one month
• Results posted on: 2024-11-29

Participant Flow

7 participants determined to be ineligible. 1 participant withdrew before protocol therapy due to an emergency

Participant milestones

Measure	IMRT IMRT with concurrent cisplatin 40 mg/m2 Intensity Modulated Radiation Therapy (IMRT): 45.0 Gy (intact) or 50.4 Gy (postoperative high-risk) in 1.8 Gy daily fractions over 5-5.5 weeks Cisplatin: Weekly infusion of 40 mg/m2 (80 mg max) x 5 weeks	PET-Guided Bone Marrow-Sparing IMRT PET-Guided Bone Marrow-Sparing IMRT with concurrent cisplatin 40 mg/m2 Intensity Modulated Radiation Therapy (IMRT): 45.0 Gy (intact) or 50.4 Gy (postoperative high-risk) in 1.8 Gy daily fractions over 5-5.5 weeks Cisplatin: Weekly infusion of 40 mg/m2 (80 mg max) x 5 weeks
Overall Study STARTED	63	46
Overall Study COMPLETED	55	46
Overall Study NOT COMPLETED	8	0

Reasons for withdrawal

Measure	IMRT IMRT with concurrent cisplatin 40 mg/m2 Intensity Modulated Radiation Therapy (IMRT): 45.0 Gy (intact) or 50.4 Gy (postoperative high-risk) in 1.8 Gy daily fractions over 5-5.5 weeks Cisplatin: Weekly infusion of 40 mg/m2 (80 mg max) x 5 weeks	PET-Guided Bone Marrow-Sparing IMRT PET-Guided Bone Marrow-Sparing IMRT with concurrent cisplatin 40 mg/m2 Intensity Modulated Radiation Therapy (IMRT): 45.0 Gy (intact) or 50.4 Gy (postoperative high-risk) in 1.8 Gy daily fractions over 5-5.5 weeks Cisplatin: Weekly infusion of 40 mg/m2 (80 mg max) x 5 weeks
Overall Study Withdrawal by Subject	1	0
Overall Study Ineligible	7	0

Baseline Characteristics

Study With Intensity Modulated Radiation Therapy With Cisplatin to Treat Stage I-IVA Cervical Cancer

Baseline characteristics by cohort

Measure	IMRT n=55 Participants All patients receive IMRT with concurrent cisplatin 40 mg/m2 Intensity Modulated Radiation Therapy (IMRT): 45.0 Gy (intact) or 50.4 Gy (postoperative high-risk) in 1.8 Gy daily fractions over 5-5.5 weeks Cisplatin: Weekly infusion of 40 mg/m2 (80 mg max) x 5 weeks	PET-Guided Bone Marrow-Sparing IMRT n=46 Participants PET-Guided Bone Marrow-Sparing IMRT with concurrent cisplatin 40 mg/m2 Intensity Modulated Radiation Therapy (IMRT): 45.0 Gy (intact) or 50.4 Gy (postoperative high-risk) in 1.8 Gy daily fractions over 5-5.5 weeks Cisplatin: Weekly infusion of 40 mg/m2 (80 mg max) x 5 weeks	Total n=101 Participants Total of all reporting groups
Age, Continuous	54.1 years STANDARD_DEVIATION 12.9 • n=5 Participants	46 years STANDARD_DEVIATION 51.2 • n=7 Participants	52.8 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	46 Participants n=7 Participants	101 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=5 Participants	33 Participants n=7 Participants	82 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Latina/Hispanic	3 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized White, non-Hispanic	38 Participants n=5 Participants	26 Participants n=7 Participants	64 Participants n=5 Participants
Race/Ethnicity, Customized Other/unknown	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Kamofsky Status 70	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Kamofsky Status 80	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Kamofsky Status 90	22 Participants n=5 Participants	17 Participants n=7 Participants	39 Participants n=5 Participants
Kamofsky Status 100	29 Participants n=5 Participants	27 Participants n=7 Participants	56 Participants n=5 Participants
Grade 1	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Grade 2	28 Participants n=5 Participants	16 Participants n=7 Participants	44 Participants n=5 Participants
Grade 3	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Grade Not graded	6 Participants n=5 Participants	13 Participants n=7 Participants	19 Participants n=5 Participants
Figo Stage IB1	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Figo Stage IB2	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Figo Stage IIA1	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Figo Stage IIB	41 Participants n=5 Participants	25 Participants n=7 Participants	66 Participants n=5 Participants
Figo Stage IIIB	3 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants
Figo Stage IVA	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Histologic Status Squamous cell Carcinoma	47 Participants n=5 Participants	36 Participants n=7 Participants	83 Participants n=5 Participants
Histologic Status Adenocarcinoma	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 30 days post radiation, about one month

Acute grade >= 3 neutropenia or clinically significant >=2 diarrhea or any grade >=3 GI toxicity

Outcome measures

Measure	IMRT Arm (Phase II) n=55 Participants IMRT with concurrent cisplatin 40 mg/m2 Cisplatin: Weekly infusion of 40 mg/m2 (80 mg max) x 5 weeks	PET-Guided BMS-IMRT (Phase II) n=46 Participants PET-Guided BMS-IMRT with concurrent cisplatin 40 mg/m2 Intensity Modulated Radiation Therapy (IMRT): 45.0 Gy (intact) or 50.4 Gy (postoperative high-risk) in 1.8 Gy daily fractions over 5-5.5 weeks Cisplatin: Weekly infusion of 40 mg/m2 (80 mg max) x 5 weeks
Primary Event (Acute Hematologic or GI Toxicity)	55 Participants	46 Participants

SECONDARY outcome

Timeframe: Up to 36 Months post treatment, a total of about 38 months

Time from registration to first recurrence of disease or death from any cause

Outcome measures

Measure	IMRT Arm (Phase II) n=46 Participants IMRT with concurrent cisplatin 40 mg/m2 Cisplatin: Weekly infusion of 40 mg/m2 (80 mg max) x 5 weeks	PET-Guided BMS-IMRT (Phase II) n=55 Participants PET-Guided BMS-IMRT with concurrent cisplatin 40 mg/m2 Intensity Modulated Radiation Therapy (IMRT): 45.0 Gy (intact) or 50.4 Gy (postoperative high-risk) in 1.8 Gy daily fractions over 5-5.5 weeks Cisplatin: Weekly infusion of 40 mg/m2 (80 mg max) x 5 weeks
Progression-free Survival	46 Participants	55 Participants

SECONDARY outcome

Timeframe: Up to 30 days post-treatment, about one month

Acute grade 2 and 3 Adverse Events occurring Up to 30 days post-treatment

Outcome measures

Measure	IMRT Arm (Phase II) n=46 Participants IMRT with concurrent cisplatin 40 mg/m2 Cisplatin: Weekly infusion of 40 mg/m2 (80 mg max) x 5 weeks	PET-Guided BMS-IMRT (Phase II) n=55 Participants PET-Guided BMS-IMRT with concurrent cisplatin 40 mg/m2 Intensity Modulated Radiation Therapy (IMRT): 45.0 Gy (intact) or 50.4 Gy (postoperative high-risk) in 1.8 Gy daily fractions over 5-5.5 weeks Cisplatin: Weekly infusion of 40 mg/m2 (80 mg max) x 5 weeks
Acute Adverse Events Grade 2 or higher GI toxicity	17 participants	17 participants
Acute Adverse Events Grade 3 or higher GI toxicity	2 participants	1 participants
Acute Adverse Events Grade 3 or higher hematologic toxicity	17 participants	25 participants

Adverse Events

IMRT

Serious events: 0 serious events

Other events: 55 other events

Deaths: 0 deaths

PET-Guided Bone Marrow-Sparing IMRT

Serious events: 0 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	IMRT n=55 participants at risk All patients receive IMRT with concurrent cisplatin 40 mg/m2 Intensity Modulated Radiation Therapy (IMRT): 45.0 Gy (intact) or 50.4 Gy (postoperative high-risk) in 1.8 Gy daily fractions over 5-5.5 weeks Cisplatin: Weekly infusion of 40 mg/m2 (80 mg max) x 5 weeks	PET-Guided Bone Marrow-Sparing IMRT n=46 participants at risk All patients receive PET-Guided Bone Marrow-Sparing IMRT with concurrent cisplatin 40 mg/m2 Intensity Modulated Radiation Therapy (IMRT): 45.0 Gy (intact) or 50.4 Gy (postoperative high-risk) in 1.8 Gy daily fractions over 5-5.5 weeks Cisplatin: Weekly infusion of 40 mg/m2 (80 mg max) x 5 weeks
Gastrointestinal disorders Clinically significant GI toxicity	32.7% 18/55 • Number of events 18 • 38 months	41.3% 19/46 • Number of events 19 • 38 months
Investigations Grade 3 or higher neutropenia	90.9% 50/55 • Number of events 50 • 38 months	60.9% 28/46 • Number of events 28 • 38 months
Gastrointestinal disorders Grade 2 GI toxicity	30.9% 17/55 • Number of events 17 • 38 months	37.0% 17/46 • Number of events 17 • 38 months
Gastrointestinal disorders Grade 3 or higher GI toxicity	1.8% 1/55 • Number of events 1 • 38 months	4.3% 2/46 • Number of events 2 • 38 months
Investigations Grade 3 or higher hematologic toxicity	45.5% 25/55 • Number of events 25 • 38 months	37.0% 17/46 • Number of events 17 • 38 months

Additional Information

Dr. Loren Mell

UCSD Moores Cancer Center

Phone: 858-246-4071

Email: lmell@health.ucsd.edu

Results disclosure agreements

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