Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Capecitabine

Leucovorin

Fluorouracil

Levoleucovorin

Oxaliplatin

Folic Acid

Tetrahydrofolates

Formyltetrahydrofolates

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

* Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction.
* An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy.
* Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy.
* Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles
* Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX

Radiation

Hyun Kim, M.D.

The purpose of this research study is to look at how tumors responds to a short course of radiation (5 days) followed by 8 cycles of chemotherapy.

Non-Operative Radiation Management of Adenocarcinoma of the Lower Rectum

Non-Operative Radiation Management of Adenocarcinoma of the Lower Rectum (NORMAL-R)

* Criteria for complete clinical response:

  * No residual gross tumor at procto/sigmoidoscopy, or only erythematous scar or ulcer
  * No radiographic evidence of tumor on DRE
  * Substantial downsizing on MRI
  * No suspicious mesorectal lymph nodes on MRI
  * Negative biopsy from scar, ulcer, or former tumor site (if necessary according to surgeon's judgment)
* Criteria for no significant clinical response:

  * Residual disease by DRE, endoscopy or MR.
  * Increase in primary tumor size upon clinical exam or imaging
  * Any new lesions

-The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much).

-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

-The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much)

Washington University School of Medicine

Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

1 participant was not evaluable for this outcome measure as they were removed for an adverse event

Complete Response Rate

I have a lack of energy

I have nausea

Because of my physical condition, I have trouble meeting the needs of my family

I have pain

I am bothered by side effects of treatment

I feel ill

I am forced to spend time in bed

I feel close to my friends

I get emotional support from my family

I get support from my friends

My family has accepted my illness

I am satisfied with family communication about my illness

I feel close to my partner (or the person who is my main support)

I am satisfied with my sex life

I feel sad

I am satisfied with how I am coping with my illness

I am losing hope in the fight against my illness

I feel nervous

I worry about dying

I worry that my condition will get worse

I am able to work (include work at home)

My work (include work at home) is fulfilling

I am able to enjoy life

I have accepted my illness

I am sleeping well

I am enjoying the things I usually do for fun

I am content with the quality of my life right now

I have swelling or cramps in my stomach area

I am losing weight

I have control of my bowels

I can digest my food well

I have diarrhea (diarrhoea)

I have a good appetite

I like the appearance of my body

I am embarrassed by my ostomy appliance

Caring for my ostomy appliance is difficult

-Participant is asked about specific well-being in the past 7 days

0=Not at All

1=A Little Bit

2=Somewhat

3=Quite a Bit

4=Very Much

-Participant did not answer question about well-being

Prefer Not to Answer/No Answer/No

Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire

One participant was not evaluable for this outcome measure because they did not complete chemoradiation.

One participant was not evaluable for this outcome measure because they did not complete chemoradiation. One participant was not evaluable for this outcome measure because they expired prior to this timepoint.

Spots Global Cancer Trial Database for Non-Operative Radiation Management of Adenocarcinoma of the Lower Rectum

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial