Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy for Cancer of Rectum

Phase-Based Estimates
1
Effectiveness
1
Safety
Washington University School of Medicine, Saint Louis, MO
Cancer of Rectum+2 More
Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy - Radiation
Eligibility
18+
All Sexes
Eligible conditions
Cancer of Rectum

Study Summary

This study is evaluating whether a new type of radiation therapy may be effective for individuals with recurrent rectal cancer.

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Eligible Conditions

  • Cancer of Rectum
  • Rectal Neoplasms
  • Relapse
  • Recurrence
  • Recurrent Rectal Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy will improve 1 primary outcome and 8 secondary outcomes in patients with Cancer of Rectum. Measurement will happen over the course of Within 6-8 weeks post-completion of radiation therapy (estimated to be 7-9 weeks).

Month 12
Median freedom from locoregional progression (FFLP)
Median overall survival (OS)
Median progression-free survival (PFS)
Month 12
Frequency of late adverse events as measured by CTCAE v 5.0
Month 3
Frequency of acute adverse events as measured by CTCAE v 5.0
Month 12
Change in quality of life as measured by the EORTC QLQ-C30
Change in quality of life as measured by the EORTC QLQ-CR29
Month 42
Maximum tolerated dose (MTD) of reirradiation using hypofractionated IMPT
Week 9
Clinical complete response rate

Trial Safety

Trial Design

3 Treatment Groups

No Control Group
Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)

This trial requires 20 total participants across 3 different treatment groups

This trial involves 3 different treatments. Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 1. The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 2. The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 3. The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: prior to start of radiation therapy, 1-2 weeks post radiation therapy, 3 months post radiation therapy, 6 months post radiation therapy, 9 months post radiation therapy and 12 months post radiation therapy
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly prior to start of radiation therapy, 1-2 weeks post radiation therapy, 3 months post radiation therapy, 6 months post radiation therapy, 9 months post radiation therapy and 12 months post radiation therapy for reporting.

Closest Location

Washington University School of Medicine - Saint Louis, MO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Cancer of Rectum or one of the other 2 conditions listed above. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
History of biopsy-proven adenocarcinoma of the rectum, anus or rectosigmoid junction of any stage now with recurrent disease in the pelvis
One prior course of radiation therapy to the pelvis for rectal cancer
ECOG performance status 0-2
At least 18 years of age
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
Able to understand and willing to sign an IRB-approved written informed consent document.

Patient Q&A Section

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

Can cancer of rectum be cured?

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This small series show that cancer of rectum can not be cured. However, it is possible to improve the local resectability of the disease and to increase the number of locally cured patients.

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

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Approximately 70,000 cases of cancer of rectum are diagnosed a year in the United States. This makes it the second most common cancer of the large intestine.

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What are common treatments for cancer of rectum?

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Treatment for [rectal cancer](https://www.withpower.com/clinical-trials/rectal-cancer) is dependent on the type of cancer and how advanced it is, but many options exist. Common options include surgery, radiation therapy, chemotherapy, and the use of target treatment. There is no cure for rectal cancer, so treatment is focused on symptom management and supportive care.

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What are the signs of cancer of rectum?

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Rectal bleeding with [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) is an early presentation of the disease. Therefore, these patients can be diagnosed and treated by themselves avoiding referrals from doctors. Symptoms of rectal cancer include rectal bleeding, abdominal pain, dyspareunia or pain or incomplete evacuation. Other symptoms of rectal cancer include rectal bleeding, anemia, loose stools, anemia, urinary obstruction.

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What causes cancer of rectum?

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The risk of developing cancer of rectum is increasing. Increasing numbers of births that are carried at term may confer a protective effect against carcinogenic exposures in childhood.

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What is cancer of rectum?

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Rectal cancer can occur at any age group, often occurs in patients with a family history of this cancer and has a dismal prognosis. The overall 5-year survival is about 37%, the median number of disease-free years 10.3, and the mortality rate, 10.5% in the USA. Patients having curative surgery have a very improved prognosis, a very high 5-year survival of 92.1%, and a median number of disease-free year of 8.5.

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What are the common side effects of hypofractionated pencil-beam scanning intensity-modulated proton therapy?

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With PB-SIMT, a high dosage of radiation can be delivered to an optimal degree of conformity and sparing of critical structures. Furthermore, a low dosage of radiation will also be delivered to an optimal degree of conformity with sparing of normal tissues. Radiation-induced long-term side effects and side effects caused by hyperfractionation were significantly reduced.

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What is the latest research for cancer of rectum?

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A high rate of [mortality in cancer of rectum] is associated with obesity and age, and is probably caused by tumor growth and metastasis. In addition, an increasing number of obese patients are diagnosed with cancer of rectum. This condition may be associated with a relatively high mortality rate because metastasis will lead to distant cancer, which will further lead to a high mortality rate.

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What does hypofractionated pencil-beam scanning intensity-modulated proton therapy usually treat?

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HPB-SMI-IMT was applied to a small number of rectal tumors. Most of the tumors were found to be less than 5 cm or to be of lower grade. Therefore, a potential role of HPB-SMI-IMT in postoperative radiotherapy of rectal tumors can be assumed.

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What is the survival rate for cancer of rectum?

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The survival rate from cancer of rectum was 71% for stage I and IIA cancer. Stage IIIB (IV) and IV rectal cancer had a survival rate of 41% and 46% respectively, whereas stage IVA had a survival rate of 44%.

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What are the chances of developing cancer of rectum?

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Although colon and rectum cancers are similar in terms of overall distribution and survival, there are important differences in distribution and survival between patients with tumors of the rectum, or the lower colon, and those with tumors of the upper colon.

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Who should consider clinical trials for cancer of rectum?

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There are many clinical trials in process or completed for rectum cancer, so there is a need for physicians and patients to join a clinical trial. Because it is important to take into account the impact of participation in clinical trials on quality of life, the decision-making process must be preceded by discussion between the patient and his/her doctor. Because the number of participants that need to be included for a clinical trial of a new treatment should be restricted to reach statistically significant results, we consider that clinical trials should be considered for patients in high risk population (male with family history).

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