Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Rectal Carcinoma | Rectal Carcinoma | CURATED_BROADER | 0.78 |
| Rectal Adenocarcinoma | Rectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage IIA Rectal Cancer AJCC v8 | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Rectal Cancer AJCC v8 | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIC Rectal Cancer AJCC v8 | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Rectal Cancer AJCC v8 | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Rectal Cancer AJCC v8 | Malignant Rectal Neoplasm | CURATED_BROADER |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Fluorouracil | Drug | Fluorouracil | ALIAS |
| Intensity-Modulated Radiation Therapy | Radiation | — | UNRESOLVED |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Surveillance | Behavioral | — | UNRESOLVED |
| Total Mesorectal Excision | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (IMRT, mFOLFOX6, CapeOX, TME)
- description
- Patients undergo SCRT in the form of IMRT over 5 fractions daily for 5 consecutive days. Beginning 11-18 days after the last day of radiation therapy, patients receive either oxaliplatin IV and leucovorin IV on day 1 and fluorouracil IV on days 1-3 (mFOLFOX6) or oxaliplatin IV on day 1 and capecitabine PO BID on days 1-14 (CapeOX). Treatment with mFOLFOX6 repeats every 2 weeks for up to 8 cycles, and treatment with CapeOX repeats every 3 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. At 8-12 weeks after completion of all therapy, patients with residual tumor undergo TME. Patients with cCR undergo NOM.
- interventionNames
- Drug: Capecitabine
- Drug: Fluorouracil
- Radiation: Intensity-Modulated Radiation Therapy
- Drug: Leucovorin
- Drug: Oxaliplatin
- Other: Quality-of-Life Assessment
- Behavioral: Surveillance
- Procedure: Total Mesorectal Excision
Primary outcomes (1)
- measure
- Complete clinical response rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available