All > Rectal Cancer

Oxaliplatin for Colorectal Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Columbia University Irving Medical Center/NYPH, New York, NYColorectal CancerOxaliplatin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial shows that TASOX can be safely and effectively given after a short course of radiation, allowing for successful R0 surgery and local control in patients with stage II/III rectal cancer.

Eligible Conditions
  • Colorectal Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Irinotecan
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Trifluridine and Tipiracil Hydrochloride
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Epacadostat

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Through study completion, an average of 6 months

Month 6
Achieve a reduction by at least 5.8 in Neoadjuvant Response (NAR) score compared to historic controls with NAR of 14.59
Safety and Tolerability

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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Side Effects for

Bevacizumab: Phase A and Phase B
68%Nausea
63%Fatigue
63%Neuropathy peripheral
55%Diarrhoea
40%Constipation
31%Abdominal pain
30%Palmar-plantar erythrodysaesthesia syndrome
28%Vomiting
25%Neutropenia
24%Mucosal inflammation
23%Epistaxis
22%Decreased appetite
20%Insomnia
20%Paraesthesia
20%Gastrooesophageal reflux disease
20%Alopecia
19%Headache
18%Hypertension
17%Stomatitis
17%Back pain
16%Dysgeusia
16%Rash
16%Urinary tract infection
14%Pain in extremity
14%Upper respiratory tract infection
13%Mouth ulceration
13%Thrombocytopenia
13%Arthralgia
12%Dysaesthesia
12%Anaemia
11%Weight decreased
11%Musculoskeletal pain
11%Oedema peripheral
10%Cough
10%Dyspnoea
10%Pulmonary embolism
10%Abdominal pain upper
10%Dizziness
10%Dyspepsia
9%Depression
9%Dysphonia
9%Pyrexia
8%Fall
8%Anxiety
8%Proteinuria
8%Dry skin
7%Abdominal distension
7%Rectal haemorrhage
7%Lethargy
7%Toothache
7%Neck pain
6%Non-cardiac chest pain
6%Dehydration
6%Rhinorrhoea
6%Oropharyngeal pain
5%Muscle spasms
5%Intestinal obstruction
5%Oral herpes
5%Sepsis
5%Nail disorder
5%Hypotension
5%Haemorrhoids
5%Oral candidiasis
5%Hypoalbuminaemia
5%Hypokalaemia
2%Angina pectoris
2%Small intestinal obstruction
2%Flank pain
2%Enterovesical fistula
2%Pneumonia
2%Febrile neutropenia
2%Gastroenteritis
2%Lower respiratory tract infection
2%Anal abscess
2%Bronchitis
2%Renal failure acute
2%Confusional state
1%Thrombophlebitis superficial
1%Anal fissure
1%Visual impairment
1%Colitis
1%Gastritis
1%Ileus
1%Inguinal hernia
1%Intestinal perforation
1%Large intestinal obstruction
1%Large intestine perforation
1%Melaena
1%Neutropenic colitis
1%Catheter site pain
1%Enterocolitis infectious
1%Eyelid infection
1%Infusion related reaction
1%Hypophagia
1%Urinary incontinence
1%Pneumonia aspiration
1%Rectal perforation
1%Dysphagia
1%Colonic obstruction
1%Haematuria
1%Gangrene
1%Urosepsis
1%Pneumonia streptococcal
1%Radius fracture
1%Musculoskeletal chest pain
1%Procedural pain
1%Cerebrovascular accident
1%Extravasation
1%Gastrointestinal perforation
1%Gastrointestinal haemorrhage
1%Cholecystitis acute
1%Infective exacerbation of chronic obstructive airways disease
1%Abscess limb
1%Lobar pneumonia
1%Pilonidal cyst
1%Ear infection
1%Wound infection
1%Procedural site reaction
1%Hemiparesis
1%Clostridium difficile colitis
1%Device related infection
1%Muscle abscess
1%Pleural effusion
1%Pharyngitis
1%Laceration
1%Hypomagnesaemia
1%Infected dermal cyst
1%Gastroenteritis viral
1%Syncope
1%Transient ischaemic attack
1%Acute psychosis
1%Pleuritic pain
1%Hydronephrosis
1%Jugular vein thrombosis
1%Orthostatic hypotension
This histogram enumerates side effects from a completed 2016 Phase 4 trial (NCT01588990) in the Bevacizumab: Phase A and Phase B ARM group. Side effects include: Nausea with 68%, Fatigue with 63%, Neuropathy peripheral with 63%, Diarrhoea with 55%, Constipation with 40%.

Trial Design

1 Treatment Group

TAS102 plus Oxaliplatin
1 of 1

Experimental Treatment

27 Total Participants · 1 Treatment Group

Primary Treatment: Oxaliplatin · No Placebo Group · Phase 2

TAS102 plus OxaliplatinExperimental Group · 2 Interventions: TAS 102, Oxaliplatin · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAS 102
2017
Completed Phase 1
~40
Oxaliplatin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 6 months

Who is running the clinical trial?

Providence Health & ServicesLead Sponsor
108 Previous Clinical Trials
53,362 Total Patients Enrolled
Benaroya Research InstituteLead Sponsor
40 Previous Clinical Trials
9,129 Total Patients Enrolled
Taiho OncologyUNKNOWN
1 Previous Clinical Trials
12 Total Patients Enrolled
Houng Pham, MDPrincipal InvestigatorVirginia mason medical Center
Lisa A. Kachnic, MDPrincipal InvestigatorColumbia University
2 Previous Clinical Trials
108 Total Patients Enrolled
Hagen Kennecke, MDPrincipal InvestigatorProvidence Health & Services
6 Previous Clinical Trials
789 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 22 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The cancer has advanced to a certain stage, including tumors that have spread to nearby lymph nodes or are larger in size.
References

Frequently Asked Questions

Has the FDA sanctioned Oxaliplatin for public use?

"Oxaliplatin was determined to be a 2 on the safety scale because this is a Phase 2 trial, indicating that there are some records of its safety but no verifiable evidence for efficacy." - Anonymous Online Contributor

Unverified Answer

Has Oxaliplatin been investigated for any other medical applications?

"Currently, 339 clinical trials are investigating the use of Oxaliplatin with 122 in Phase 3. While many studies for this medication take place in Melbourne, Victoria there is a total of 13673 trial locations around the globe." - Anonymous Online Contributor

Unverified Answer

What is the aggregate sum of participants involved in this experiment?

"To move forward with this trial, 27 qualified patients will need to be enrolled. These individuals may come from Virginia Mason Medical Center in Orange, California or the University of California Irvine in Portland Oregon." - Anonymous Online Contributor

Unverified Answer

Are there still vacancies for volunteers in this clinical trial?

"Affirmative. Clinicaltrials.gov states that this medical trial, which was initially posted on July 5th 2022 and amended most recently on the 8th of July, is actively seeking participants. The study requires 27 patients to be recruited from 5 different research locations." - Anonymous Online Contributor

Unverified Answer

How extensively is this clinical investigation being conducted in the city?

"At present, this research is being conducted at 5 medical centres. These locations include Orange, Portland and New York in addition to two other cities. To minimize travel burdens, it would be best for prospective participants to select the closest trial site available." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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