Leucovorin for Cancer of Rectum

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Virginia, Charlottesville, VA
Cancer of Rectum+1 More
Leucovorin - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a treatment that combines surgery and chemotherapy is better than surgery and chemotherapy alone.

See full description

Eligible Conditions

  • Cancer of Rectum
  • Rectal Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Leucovorin will improve 1 primary outcome and 1 secondary outcome in patients with Cancer of Rectum. Measurement will happen over the course of 3 years.

3 years
disease-free survival (DFS)
major adverse events

Trial Safety

Safety Progress

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

Trial Design

2 Treatment Groups

INCT
1 of 2
CNCT
1 of 2
Experimental Treatment

This trial requires 358 total participants across 2 different treatment groups

This trial involves 2 different treatments. Leucovorin is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

INCTArm 1 will receive chemotherapy before chemoradiation. This is called induction neoadjuvant chemotherapy arm (INCT). The neoadjuvant chemotherapy regimen is prescribed specifically as 8 cycles of FOLFOX or 5 cycles of CapeOX over a period of approximately 15-16 weeks. Endoscopic exam (2-4 wks) after chemotherapy. If stable or response then pt will have radiation with either 5-FU or capecitabine.
CNCTArm 2 will receive chemoradiation before chemotherapy This is called the consolidation neoadjuvant chemotherapy arm (CNCT). Pt will have 6 weeks of chemoradiation therapy. Along with the radiation the pt will receive either 5-FU or capecitabine. 2-4 weeks after pt will have endoscopic exam and if stable or response pt will have will have 8 cycles of FOLFOX or 6 cycles of CapeOX.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Quality of Life Questionnaires
2005
Completed Phase 4
~1370
Leucovorin
FDA approved
Fluorouracil
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 years for reporting.

Closest Location

University of Virginia - Charlottesville, VA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Histologically confirmed diagnosis of adenocarcinoma of the rectum
Clinical Stage II (T3-4, N-) or Stage III (any T, N+) based on MRI
Rectal tumor at baseline which would be considered to require complete TME
No evidence of distant metastases
No prior pelvic radiation therapy
No prior chemotherapy or surgery for rectal cancer
Age ≥ 18 years The minimum legal age of consent for select Canadian provinces is 19
No active infections requiring systemic antibiotic treatment (oral antibiotics are acceptable at the discretion of the treating physician)
ECOG Performance status 0-2
Women with childbearing potential (WOCBP) who are negative for pregnancy test (urine or blood) and who agree to use effective contraceptive method. A woman of childbearing potential is defined of one who is biologically capable of becoming pregnant. Reliable contraception should be used from trial screening and must be continued throughout the study.

Patient Q&A Section

What causes cancer of rectum?

"Of patients presenting with rectal adenocarcinoma, 14% had an ulcerative colitis (UC). The presence of ulcerative colitis was associated with synchronous [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) in both cases and patients developing new cancers after previous colorectal cancer. The synchronous or metachronous occurrence of colorectal cancer in patients with UC is of interest if the cancer of rectum is suspected. The presence of UC warrants careful attention by health professionals concerning the possible presence of colorectal cancer and evaluation for synchronous colorectal cancers, particularly in cases of colorectal carcinoma." - Anonymous Online Contributor

Unverified Answer

What is cancer of rectum?

"About two-thirds of [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer)s are rectal cancers. In the USA, the incidence of rectal cancers is about 4 times higher in males than in females. Most colon cancers in males are adenomas whereas in females they are sessile and invasive. The prognosis is worse for rectal cancers than colon cancers in males and colon cancers in females." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cancer of rectum?

"Radical surgery is the only proven treatment and has the greatest impact in long-term survival in colorectal cancer patients. We propose that proton pump inhibitor, a kind of low-dose aspirin may also be effective preventive agent for colorectal cancer. The impact of radiation or chemotherapy is also controversial." - Anonymous Online Contributor

Unverified Answer

How many people get cancer of rectum a year in the United States?

"At least 1,000 new cases arise each year in the United States, of which nearly 750,000 were [colo[rectal cancer](https://www.withpower.com/clinical-trials/rectal-cancer)](https://www.withpower.com/clinical-trials/colorectal-cancer). The most common of the rectal cancers is one of the most common types; the most frequent in males and the most common in the elderly; and the rates of these cancers are low in young and middle aged persons. Rectal cancers occur with a higher frequency in persons on the white side of the racial divide." - Anonymous Online Contributor

Unverified Answer

What are the signs of cancer of rectum?

"Dyspareunia is common in rectal cancer. Rectal mass and perineal pain would be very suggestive of this condition. Tumor markers such as CEA and CA125 can help in making this diagnosis." - Anonymous Online Contributor

Unverified Answer

Can cancer of rectum be cured?

"Even if there were no cure for rectal cancer it would still represent a cure for colorectal cancer as the cure for colorectal cancer is the cure for rectal cancer. The cure for rectal cancer is not feasible." - Anonymous Online Contributor

Unverified Answer

Does leucovorin improve quality of life for those with cancer of rectum?

"Adding leucovorin to a standard chemotherapy regimen for patients with disease of the rectum, as compared with a placebo, was associated with worse QOL and increased side effects. This confirms the importance of identifying effective chemopreventive treatments for cancer patients." - Anonymous Online Contributor

Unverified Answer

What is the latest research for cancer of rectum?

"Results from a recent clinical trial shows that the incidence of [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) is increasing and that the disease can invade lymphatic vessels and tumor cells spread along the lymph nodes. This cancer has a poor prognosis from the time of its onset, and also from the time of operation." - Anonymous Online Contributor

Unverified Answer

Does cancer of rectum run in families?

"Genetic analysis of people with rectal cancer indicates that the rectal neoplasia is likely due to multiple genetic defects; the most common type is a predisposition to polyposis intestinalis, with a second modifier gene, presumably epigenetic, underlying sporadic disease." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving leucovorin?

"There were no reports of other clinical research involving leucovorin. We urge patients to report side effects to [the prescribing doctor], [a health centre] or the UPCR, through the Contact Numbers and other sources available." - Anonymous Online Contributor

Unverified Answer

How quickly does cancer of rectum spread?

"This retrospective study revealed that cancer of rectum might spread more quickly than colon cancer. However, there was no difference between colon and rectosigmoid cancers in tumor stage at the time of resection or in the presence of nodal or distant tumor. In view of our limited sample size, these results need confirmation with larger samples." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing cancer of rectum?

"Risk of developing [rectal cancer](https://www.withpower.com/clinical-trials/rectal-cancer) increases by age. Risk of rectal cancer in males is higher than in females, which suggests different predisposition (or environmental factors) in males and females. Risk of developing an intrastructal carcinoma is significantly higher in smokers. These statistics confirm and refine the results of [Hepatorenal cancer in relation to occupation]] (2011), with a statistically significant risk for women employed in the services (health and social), self-employed (managers), and sales workers (sales)." - 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.
See if you qualify for this trial
Get access to this novel treatment for Cancer of Rectum by sharing your contact details with the study coordinator.