Clinical trial · Interventional
Radiation Therapy, Pemetrexed Disodium, and Carboplatin in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed By Surgery
A Phase II Trial of Preoperative Radiation and Chemotherapy (Pemetrexed and Carboplatin) for Locally Advanced Esophageal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Trial closed early because, during an interim analysis, the primary endpoint fell short.
Summary
Brief summary (as posted)
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation therapy together with pemetrexed disodium and carboplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving radiation therapy together with pemetrexed disodium and carboplatin works in treating patients with locally advanced esophageal cancer that can be removed by surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pemetrexed/Carboplatin
- description
- Pemetrexed+Carboplatin+Radiation
- interventionNames
- Drug: carboplatin
- Drug: Pemetrexed
- Procedure: conventional surgery
- Procedure: neoadjuvant therapy
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Pathologic Complete Response Rate
- timeFrame
- Baseline to time of surgery (around 10 - 18 weeks post-baseline)
- description
- The proportion of pathologic complete responses will be estimated by the number of pathologic complete responses divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true pathologic complete response rate will be calculated. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for Measurable disease is defined as at least one lesion whose longest diameter can be accurately measured as ≥2.0 cm with conventional techniques or as ≥1.0 cm with spiral CT. Lesions on chest x-ray are acceptable as measurable lesions when they are clearly defined and surrounded by aerated lung. However, CT is preferable.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal (GE) junction
* No T1-2, N0, M0 disease
* No palpable or biopsy-proven involvement of supraclavicular nodes or radiographically involved supraclavicular nodes (\> 1.5 cm in greatest dimension) for lesions in mid-thoracic, distal thoracic, or GE junction
\+ Supraclavicular node involvement allowed provided there are upper thoracic esophagus primary lesions
* Patients with involvement of celiac nodes (stations 15-20) are eligible if the primary lesion is mid-thoracic, distal esophagus, or GE junction
* No evidence of distant metastases
* Tumor must be considered surgically resectable
\- Patients with T4, N0 tumors that are potentially resectable are eligible
* No clinically relevant pleural or peritoneal effusion that is not amenable to drainage
PATIENT CHARACTERISTICS:
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Life expectancy ≥ 12 weeks
* Absolute neutrophil count ≥1,500/mm\^3
* Platelet count ≥100,000/mm\^3
* Hemoglobin ≥10 g/dL
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST ≤ 3 times ULN
* Creatinine clearance ≥ 45 mL/min
* No New York Heart Association class III or IV congestive heart failure
* Pregnant or nursing women are ineligible
* Negative pregnancy test
* Fertile patients must use effective contraception
* No uncontrolled infection
* No other severe underlying disease that would preclude study entry
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ
* No prior sensitivity or allergic reaction to pemetrexed disodium or carboplatin
* Able to swallow pills
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy for esophageal cancer
* No prior radiotherapy field that overlapped the anticipated fields of study radiotherapy
* No prior radiotherapy to \> 30% of the marrow cavity
* Patients taking nonsteroidal anti-inflammatory drugs (NSAIDs) must be able to discontinue use 2 days prior, during, and 2 days after pemetrexed disodium administration (5 days prior for long-life NSAIDs)
* Patients must not have been receiving cyclooxygenase-2 inhibitors at study entry and while receiving protocol therapyReferences
Publications (2)
- RESULTJatoi A, Soori G, Foster NR, Hiatt BK, Knost JA, Fitch TR, Callister MD, Nichols FC 3rd, Husted TM, Alberts SR. Phase II study of preoperative pemetrexed, carboplatin, and radiation followed by surgery for locally advanced esophageal cancer and gastroesophageal junction tumors. J Thorac Oncol. 2010 Dec;5(12):1994-8. doi: 10.1097/JTO.0b013e3181fb5c3e. PMID 20975604
- RESULTKatipamula R, Jatoi A, Foster NR, Nichols F, Rubin J, Callister M, Gunderson L, Alberts S. Pemetrexed, Carboplatin, and Concomitant Radiation followed by Surgery for Locally Advanced Esophageal Cancer: Results of a Planned Interim Toxicity Analysis of North Central Cancer Treatment Group Study N044E. Clin Med Oncol. 2008;2:223-5. doi: 10.4137/cmo.s444. Epub 2008 Apr 1. PMID 21892283