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RecruitingPhase 1

Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer

Organ Preservation for Patients With Locally Advanced Rectal Adenocarcinoma: Evaluating the Efficacy of Short Course Radiation Therapy Followed by FOLFOX or CapeOX

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years, 3 years
  • Procedures mentioned: X-rays, MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors."
  • "Explore radiomics features from longitudinal diffusion weighted magnetic resonance imaging (MRI) (diffusion weighted imaging \[DWI\]) data and build a predictive model for treatment effect (complete response) in rectal cancer patients undergoing SCRT."
  • "After completion of study treatment, patients who underwent NOM are followed up every 3 months for 2 years, then every 6 months for 3 years."
  • "TME patients are followed up every 3-6 months for 2 years, then every 6 months for 3 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early-stage study tests a short course of radiation followed by a mix of chemotherapy drugs for people with stage II–III rectal cancer. Radiation uses high-energy x-rays, and chemotherapy uses drugs to fight cancer. Researchers want to learn whether this treatment may reduce the need for surgery and improve quality of life.

This phase I trial investigates how well short-course radiation therapy followed by combination chemotherapy works in treating patients with stage II-III rectal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as leucovorin, fluorouracil, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving short-course radiation therapy and combination chemotherapy may reduce the need for surgery and therefore improve quality of life.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A tissue test must confirm rectal adenocarcinoma, a cancer that starts in gland cells in the rectum.
  • An MRI scan must show stage II (cT3, cN0) or stage III (cT1–3, cN1–3) cancer.
  • The cancer must not have spread to distant parts of the body, and the main tumor must be removable by surgery.
  • Must be able to do some daily activities, with an activity score of KPS 70 or higher or ECOG 0–2.
  • Neutrophils, a type of infection-fighting white blood cell, must be above 1.5 cells/mm³.
  • Hemoglobin, which carries oxygen in blood, must be above 8.0 g/dL. Platelets, which help blood clot, must be above 150,000/mm³.
  • Liver blood tests must meet these limits: bilirubin no more than 1.5 times the upper normal limit, and AST and ALT no more than 3 times that limit.
  • Women who can become pregnant must have a negative blood pregnancy test before starting radiation.

Who can't join

  • Currently receiving treatment for another cancer.
  • Cancer has spread to distant parts of the body, as shown by PET/CT or chest and belly CT scans within 6 weeks of starting radiation.
  • Past radiation in the same area would overlap with the study radiation.
  • Pregnant or breastfeeding.
  • A medical or mental health condition prevents having an MRI scan.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Histologically confirmed rectal adenocarcinoma * Patients must have stage II (cT3, cN0) or stage III (cT1-3, cN1-3) tumor as staged by MRI * No evidence of metastatic disease * Resectable primary lesion * Karnofsky performance status (KPS) \>= 70 or Eastern Cooperative Oncology Group (ECOG) 0-2 * Absolute neutrophil count (ANC) \> 1.5 cell/mm\^3 * Hemoglobin (Hgb) \> 8.0 gm/dL * Platelets (PLT) \> 150,000/mm\^3 * Total bilirubin \< or equal to 1.5 x upper limit of normal * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< or equal to three times upper limit of normal * If a woman is of childbearing potential, a negative serum pregnancy test must be documented prior to initiation of radiation therapy Exclusion Criteria: * Active treatment of a separate malignancy * Distant metastatic disease as assessed by staging positron emission tomography (PET)/computed tomography (CT) or CT of the chest and abdomen within 6 weeks of starting radiation therapy * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields * Pregnant and/or breastfeeding * Medical/psychological contraindication to MRI

Study sites (1)

CA