Trial Outcomes & Findings for Pelvic Radiotherapy With Concurrent Neoadjuvant FOLFOX for Patients With Newly Diagnosed Rectal Adenocarcinoma (NCT NCT02319304)

Results Overview

Overall survival rate of patients who receive a neoadjuvant full dose FOLFOX plus the addition of concurrent LDFRT result in a pCR response rate of at least 35%.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

1 year

Results posted on

2021-11-04

Participant Flow

Participant milestones

Participant milestones
Measure	Pelvic Radiotherapy With Concurrent Neoadjuvant FOLFOX Part I: FOLFOX: combination of drugs administered in a specific sequence as prescribed below. * Oxaliplatin: 85 mg/m2 intravenously (IV) over 2 hours * Leucovorin: 200 mg/m2 IV bolus over 2 hours * 5-FU: 400 mg/m2 IV bolus over 5-15 minutes, then 2,400 mg/m2 continuous IV infusion over 46-48 hours Part II: Low dose fractionated radiation therapy (LDFRT) Intensity-modulated, bone marrow sparing, whole pelvic radiation therapy 40 cGy fractions twice per day delivered at least 4-6 hours apart on the first 2 days of each chemotherapy cycle for a total of 6 cycles FOLFOX {5-fluorouracil (5-FU), leucovorin, and oxaliplatin}: see arm description Low dose fractionated radiation therapy (LDFRT): see arm description
Overall Study STARTED	3
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pelvic Radiotherapy With Concurrent Neoadjuvant FOLFOX for Patients With Newly Diagnosed Rectal Adenocarcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pelvic Radiotherapy With Concurrent Neoadjuvant FOLFOX n=3 Participants Part I: FOLFOX: combination of drugs administered in a specific sequence as prescribed below. * Oxaliplatin: 85 mg/m2 intravenously (IV) over 2 hours * Leucovorin: 200 mg/m2 IV bolus over 2 hours * 5-FU: 400 mg/m2 IV bolus over 5-15 minutes, then 2,400 mg/m2 continuous IV infusion over 46-48 hours Part II: Low dose fractionated radiation therapy (LDFRT) Intensity-modulated, bone marrow sparing, whole pelvic radiation therapy 40 cGy fractions twice per day delivered at least 4-6 hours apart on the first 2 days of each chemotherapy cycle for a total of 6 cycles FOLFOX {5-fluorouracil (5-FU), leucovorin, and oxaliplatin}: see arm description Low dose fractionated radiation therapy (LDFRT): see arm description
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	64 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	3 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Overall survival rate of patients who receive a neoadjuvant full dose FOLFOX plus the addition of concurrent LDFRT result in a pCR response rate of at least 35%.

Outcome measures

Outcome measures
Measure	Pelvic Radiotherapy With Concurrent Neoadjuvant FOLFOX n=3 Participants Part I: FOLFOX: combination of drugs administered in a specific sequence as prescribed below. * Oxaliplatin: 85 mg/m2 intravenously (IV) over 2 hours * Leucovorin: 200 mg/m2 IV bolus over 2 hours * 5-FU: 400 mg/m2 IV bolus over 5-15 minutes, then 2,400 mg/m2 continuous IV infusion over 46-48 hours Part II: Low dose fractionated radiation therapy (LDFRT) Intensity-modulated, bone marrow sparing, whole pelvic radiation therapy 40 cGy fractions twice per day delivered at least 4-6 hours apart on the first 2 days of each chemotherapy cycle for a total of 6 cycles FOLFOX {5-fluorouracil (5-FU), leucovorin, and oxaliplatin}: see arm description Low dose fractionated radiation therapy (LDFRT): see arm description
Primary Outcome Measure (Overall Survival Rate)	3 Participants

SECONDARY outcome

Timeframe: 1 year

Number of adverse events caused from the administration of neoadjuvant concurrent LDFRT-FOLFOX while maintaining a high rate of pelvic R0 resection compared to standard preoperative chemoradiation and total mesorectal excision surgery.

Outcome measures

Outcome measures
Measure	Pelvic Radiotherapy With Concurrent Neoadjuvant FOLFOX n=3 Participants Part I: FOLFOX: combination of drugs administered in a specific sequence as prescribed below. * Oxaliplatin: 85 mg/m2 intravenously (IV) over 2 hours * Leucovorin: 200 mg/m2 IV bolus over 2 hours * 5-FU: 400 mg/m2 IV bolus over 5-15 minutes, then 2,400 mg/m2 continuous IV infusion over 46-48 hours Part II: Low dose fractionated radiation therapy (LDFRT) Intensity-modulated, bone marrow sparing, whole pelvic radiation therapy 40 cGy fractions twice per day delivered at least 4-6 hours apart on the first 2 days of each chemotherapy cycle for a total of 6 cycles FOLFOX {5-fluorouracil (5-FU), leucovorin, and oxaliplatin}: see arm description Low dose fractionated radiation therapy (LDFRT): see arm description
Secondary Outcome Measure (Number of Adverse Events)	7 Adverse Events

Adverse Events

Pelvic Radiotherapy With Concurrent Neoadjuvant FOLFOX

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pelvic Radiotherapy With Concurrent Neoadjuvant FOLFOX n=3 participants at risk Part I: FOLFOX: combination of drugs administered in a specific sequence as prescribed below. * Oxaliplatin: 85 mg/m2 intravenously (IV) over 2 hours * Leucovorin: 200 mg/m2 IV bolus over 2 hours * 5-FU: 400 mg/m2 IV bolus over 5-15 minutes, then 2,400 mg/m2 continuous IV infusion over 46-48 hours Part II: Low dose fractionated radiation therapy (LDFRT) Intensity-modulated, bone marrow sparing, whole pelvic radiation therapy 40 cGy fractions twice per day delivered at least 4-6 hours apart on the first 2 days of each chemotherapy cycle for a total of 6 cycles FOLFOX {5-fluorouracil (5-FU), leucovorin, and oxaliplatin}: see arm description Low dose fractionated radiation therapy (LDFRT): see arm description
Blood and lymphatic system disorders Neutrophil Count Decreased	33.3% 1/3 • Adverse events were collected while participants were completing active treatment (approximately 6 weeks) and post-treatment (up to 13 additional weeks).
Blood and lymphatic system disorders White Blood Cell Decreased	33.3% 1/3 • Adverse events were collected while participants were completing active treatment (approximately 6 weeks) and post-treatment (up to 13 additional weeks).

Other adverse events

Other adverse events
Measure	Pelvic Radiotherapy With Concurrent Neoadjuvant FOLFOX n=3 participants at risk Part I: FOLFOX: combination of drugs administered in a specific sequence as prescribed below. * Oxaliplatin: 85 mg/m2 intravenously (IV) over 2 hours * Leucovorin: 200 mg/m2 IV bolus over 2 hours * 5-FU: 400 mg/m2 IV bolus over 5-15 minutes, then 2,400 mg/m2 continuous IV infusion over 46-48 hours Part II: Low dose fractionated radiation therapy (LDFRT) Intensity-modulated, bone marrow sparing, whole pelvic radiation therapy 40 cGy fractions twice per day delivered at least 4-6 hours apart on the first 2 days of each chemotherapy cycle for a total of 6 cycles FOLFOX {5-fluorouracil (5-FU), leucovorin, and oxaliplatin}: see arm description Low dose fractionated radiation therapy (LDFRT): see arm description
Gastrointestinal disorders Nausea	100.0% 3/3 • Adverse events were collected while participants were completing active treatment (approximately 6 weeks) and post-treatment (up to 13 additional weeks).
Gastrointestinal disorders Vomiting	33.3% 1/3 • Adverse events were collected while participants were completing active treatment (approximately 6 weeks) and post-treatment (up to 13 additional weeks).
General disorders Fatigue	100.0% 3/3 • Adverse events were collected while participants were completing active treatment (approximately 6 weeks) and post-treatment (up to 13 additional weeks).
Blood and lymphatic system disorders Platelet count Decreased	100.0% 3/3 • Adverse events were collected while participants were completing active treatment (approximately 6 weeks) and post-treatment (up to 13 additional weeks).
Blood and lymphatic system disorders White Blood Cell Decreased	100.0% 3/3 • Adverse events were collected while participants were completing active treatment (approximately 6 weeks) and post-treatment (up to 13 additional weeks).
General disorders Fever	33.3% 1/3 • Adverse events were collected while participants were completing active treatment (approximately 6 weeks) and post-treatment (up to 13 additional weeks).
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Adverse events were collected while participants were completing active treatment (approximately 6 weeks) and post-treatment (up to 13 additional weeks).

Additional Information

Caitlin Eggleston

University of Maryland Medical Center

Phone: 4103287586

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place