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Chemotherapy

Surgery for Colorectal Cancer (CORRECT Trial)

Phase 2
Waitlist Available
Led By Amol K Narang, M.D.
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights

CORRECT Trial Summary

This trial is testing a more effective cancer treatment option for rectal cancer.

Eligible Conditions
  • Colorectal Cancer

CORRECT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Patients With Pathologic Complete Response
Secondary outcome measures
Change in EORTC QLQ-C30 Global Health Status Score
Number of Participants With Grade 3 or Higher Adverse Events
Time to Death
+3 more

Side effects data

From 2023 Phase 3 trial • 521 Patients • NCT04109066
65%
Alopecia
48%
Nausea
36%
Anaemia
26%
Fatigue
25%
Aspartate aminotransferase increased
24%
Diarrhoea
21%
Alanine aminotransferase increased
20%
Vomiting
20%
Asthenia
19%
Headache
19%
Neuropathy peripheral
19%
Neutropenia
17%
Constipation
16%
COVID-19
16%
Neutrophil count decreased
15%
Arthralgia
14%
Rash
13%
Decreased appetite
13%
Hypothyroidism
12%
Hyperglycaemia
12%
White blood cell count decreased
12%
Radiation skin injury
11%
Lymphopenia
11%
Myalgia
9%
Pruritus
9%
Infusion related reaction
9%
Cough
9%
Pyrexia
9%
Urinary tract infection
9%
Epistaxis
9%
Hypertension
8%
Blood alkaline phosphatase increased
7%
Dizziness
7%
Dyspepsia
7%
Dysgeusia
7%
Hot flush
6%
Peripheral sensory neuropathy
6%
Paraesthesia
6%
Abdominal pain upper
6%
Back pain
6%
Pain in extremity
6%
Illness
6%
Mucosal inflammation
6%
Leukopenia
6%
Hypersensitivity
6%
Hyperthyroidism
6%
Insomnia
5%
Anxiety
5%
Weight decreased
5%
Blood lactate dehydrogenase increased
5%
Folliculitis
4%
Abdominal pain
4%
Blood thyroid stimulating hormone increased
4%
Dry mouth
4%
Adrenal insufficiency
4%
Oedema peripheral
4%
Pain
3%
Blood thyroid stimulating hormone decreased
3%
Dyspnoea
3%
Hyponatraemia
3%
Stomatitis
3%
Dry eye
3%
Lacrimation increased
3%
Gastrooesophageal reflux disease
3%
Nasopharyngitis
3%
Lymphocyte count decreased
3%
Hypokalaemia
2%
Nail disorder
2%
Pulmonary embolism
2%
Rash maculo-papular
2%
Postoperative wound infection
2%
Bone pain
2%
Breast pain
2%
Thrombocytopenia
2%
Depression
2%
Palpitations
2%
Dry skin
2%
Onycholysis
2%
Malignant neoplasm progression
2%
Febrile neutropenia
2%
COVID-19 pneumonia
2%
Tachycardia
2%
Procedural pain
2%
Oropharyngeal pain
1%
Left ventricular failure
1%
Thyroiditis subacute
1%
Interstitial lung disease
1%
Upper respiratory tract infection
1%
Cervix carcinoma
1%
Embolism
1%
Cardiac perfusion defect
1%
Pneumonia bacterial
1%
Cardiac failure
1%
Vertigo
1%
Myocarditis
1%
Pemphigoid
1%
Immune-mediated adrenal insufficiency
1%
Hypotension
1%
Chills
1%
Pneumonia
1%
Myelosuppression
1%
Intracranial pressure increased
1%
Cardio-respiratory arrest
1%
Myocardial infarction
1%
Colitis
1%
Anaphylactic reaction
1%
Diabetic ketoacidosis
1%
Hepatitis cholestatic
1%
Infection
1%
Glomerulonephritis
1%
Arterial thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Nivo + Chemo (PTX QW + AC Q3W) / Nivo + ET
Arm A: Nivo + Chemo (PTX QW + AC Q2W) / Nivo + ET
Arm B: Nivo Placebo + Chemo (PTX QW + AC Q3W) / ET
Arm B: Nivo Placebo + Chemo (PTX QW + AC Q2W) / ET

CORRECT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Endo-HDRExperimental Treatment3 Interventions
Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy Followed by: Oxaliplatin: 85 mg/m² in 500ml glucose 5% solution, 2-h infusion 5-Fluorouracil (5-FU) bolus 400mg/m² following the oxaliplatin/FA infusions 5-FU continuous infusion 2400 mg/m², 46-h infusion following the 5-FU bolus Cycle length: 14 days (2 weeks) Duration of treatment: 12 cycles Then: Surgical Resection
Group II: IMRT and CapecitabineActive Control4 Interventions
Patients will receive IMRT along with capecitabine. External radiotherapy will be based on contouring guidelines from the RTOG atlas and Radiation Therapy Oncology Group (RTOG 0822) with some modifications Followed by: Oxaliplatin: 85 mg/m² in 500ml glucose 5% solution, 2-h infusion 5-Fluorouracil (5-FU) bolus 400mg/m² following the oxaliplatin/FA infusions 5-FU continuous infusion 2400 mg/m², 46-h infusion following the 5-FU bolus Cycle length: 14 days (2 weeks) Duration of treatment: 12 cycles Then: Surgical Resection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Endo-HDR (if randomized to this arm)
2014
Completed Phase 2
~10
FOLFOX6
2008
Completed Phase 2
~170
Surgery
2000
Completed Phase 3
~2550

Find a Location

Who is running the clinical trial?

NucletronUNKNOWN
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,911 Total Patients Enrolled
Amol K Narang, M.D.Principal InvestigatorThe SKCCC at Johns Hopkins
1 Previous Clinical Trials
16 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many places are managing this scientific investigation?

"Currently, 4 medical centres are enrolling participants in this trial; Moffitt Cancer Center based in Tampa, The SKCCC at Johns Hopkins located in Baltimore, Beth Israel Hospital situated in New york, and other sites."

Answered by AI

In what circumstances is surgery typically employed as a mode of treatment?

"Surgical intervention is a popular approach to managing metastatic colorectal carcinoma and can also be utilized for treating advanced esophageal cancers, folate-associated disorders, and pancreatic endocrine carcinomas."

Answered by AI

To what extent can patients trust the security of surgical procedures?

"Surgery has been assessed with a rating of 2 due to its Phase 2 status, suggesting that while there is evidence of safety, efficacy still needs to be verified."

Answered by AI

How many individuals have been included in this research project?

"Unfortunately, this research programme is not accepting participants at the present moment. It was first listed on June 12th 2014 and most recently updated on October 7th 2022. If you're seeking alternative trials, there are 339 clinical studies actively recruiting patients with rectal cancer and 649 surgical trails currently admitting individuals."

Answered by AI

Are there any unfilled opportunities to participate in this clinical experiment?

"This medical trial is no longer enrolling participants. It was initially posted on June 12th 2014 and the information page was last updated October 7th 2022. However, if you are searching for other studies, there are 339 clinical trials currently recruiting patients with rectal cancer and 649 surgical procedures actively seeking volunteers."

Answered by AI

Is it possible to enlist in this medical research study?

"This medical trial is currently recruiting 138 participants who are over 18 and have rectal cancer. To be eligible, the following conditions must be satisfied: candidacy for surgery and chemotherapy, ECOG/WHO performance status 0-1 or lower, no prior pelvic radiation exposure, acceptable lung and bone marrow health profiles, absence of pregnancy or lactation with active contraception measures in place."

Answered by AI

Are there any additional investigations that have been done involving Surgery?

"Currently, 649 live clinical trials are exploring the use of Surgery. Of those studies, 219 have reached Phase 3 and most are based in Guangzhou, Guangdong. However, 26218 different medical sites worldwide offer research on this topic."

Answered by AI

Does this investigation permit participants aged twenty and over?

"This trial is accepting participants aged 18 to 100, however there are 45 distinct studies aimed at minors and 951 trials focusing on the elderly."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Chemoradiation or Brachytherapy for Rectal Cancer
2014. "Chemoradiation or Brachytherapy for Rectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02017704.
~1 spots leftby Apr 2025
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