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

Launched by JONSSON COMPREHENSIVE CANCER CENTER · Jan 7, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with stage II-III rectal cancer. It combines short-course radiation therapy, which uses high-energy x-rays to kill cancer cells, with a mix of chemotherapy drugs that work together to stop the growth of tumors. The goal of this treatment is to shrink the tumors and possibly reduce the need for surgery, which can lead to a better quality of life for patients.

To join the trial, participants need to have a specific type of rectal cancer that has been confirmed by a doctor and be in the right stage (II or III). They should also be generally healthy enough to participate, meaning they can perform daily activities without much difficulty. Participants can expect to receive the radiation and chemotherapy as part of the trial, and they will be closely monitored by healthcare professionals throughout the process. It’s important to note that this trial is currently recruiting patients, and those interested should discuss their eligibility with their healthcare provider.

Gender

ALL

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